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Meeting Psychosocial Needs of Women with Breast Cancer (2004)

Chapter: Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials

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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Suggested Citation:"Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials." Institute of Medicine and National Research Council. 2004. Meeting Psychosocial Needs of Women with Breast Cancer. Washington, DC: The National Academies Press. doi: 10.17226/10909.
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Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials Summary tables and detailed descriptions of clinical trials of the effective- ness of psychosocial interventions for women with breast cancer Table B-1 Randomized trials in “early” breast cancer Table B-2 Randomized trials in “metastatic” breast cancer Table B-3 Summary of the effectiveness of psychosocial interventions in breast cancer Boxes B-4 through B-34 Detailed description of individual studies 234

TABLE B-1 Randomized Trials in “Early” Breast Cancer Citation n Intervention(s) Duration Outcomes Maguire 172 Individual counseling by nurse Every 2 months after surgery until Nursing interventions did not reduce morbidity directly; 1980 specialist vs. control woman had “adapted well” however, it led to increased recognition of the need for 1983 psychiatric referral which, in turn, reduced psychiatric morbidity, anxiety and depression. (follow-up to 12-18 months) Christensen 20 Postmastectomy couple Weekly x 4 weeks No overall treatment effects (small sample size may have 1983 counseling vs. control precluded identification of effects). Adjusted analyses suggested tentative benefits in sexual satisfaction and psychological status (husbands and wives) and depression (wives). (follow-up to 1 week post intervention) Bridge 154 Structured relaxation vs. Weekly x 30 minutes Overall mood and relaxation better for relaxation plus 1988 relaxation plus imagery vs. x 6 weeks imagery than for relaxation alone. attention control Both better than attention control arm. (follow-up to immediately post intervention) Cimprich 32 “Restorative intervention” 20–30 minutes 3x/week Intervention improved attentional capacity and total 1993 - individualized protocol to x 7 weeks attentional score. identify and practice restorative (follow-up to immediately post intervention) experiences 235

TABLE B-1 Randomized Trials in “Early” Breast Cancer 236 Citation n Intervention(s) Duration Outcomes Burton 200 Psychological interview vs. One day – 45 minute interview, 30 Psychological interview led to lasting reduction in body 1995 interview plus 30 minutes minute psychotherapy or chat image distress and reductions in overall distress, anxiety, depression, upset regarding loss of breast and enhanced psychotherapy (surgeon) vs. fighting spirit coping. interview plus 30 minutes Psychotherapy better than chat among women with chat vs. control (all pre- stressful life events. mastectomy) (follow-up for one year – controls unaware of study until end of study, did not provide baseline data) Maunsell 259 Telephone screening of distress Monthly x 2 No significant effects. 1996 (with social work referral) vs. (average 7.6 minutes each) (follow-up to 12 months) routine care Marchioro 36 Individual cognitive therapy Weekly x 50 minutes Intervention improved depression and quality of life. 1996 focusing on problems relating to x ? duration Some changes in personality factors were noted. cancer therapy vs. standard care (follow-up to 9 months) McArdle 272 Nurse specialist support vs. Variable Support from nurse specialist resulted in improved 1996 voluntary organization support vs. somatic symptoms, social dysfunction and depression. both vs. neither Nurse support significantly better than voluntary organization support. Richardson 47 Group support (non-structured, Weekly x 1 hour Enhanced coping skills in Support (p<0.01) and Imagery 1997 supportive) vs. imagery/relaxation x 6 weeks group (p<0.07) vs. control. group with one individual session Women in both types of groups sought more support from vs. standard care others. Women in support group had greater acceptance of death. (follow-up to immediately post intervention)

TABLE B-1 Randomized Trials in “Early” Breast Cancer Citation n Intervention(s) Duration Outcomes Samarel 228 Structured support group with Weekly x 2 hours Support group with coaching resulted in higher quality 1992 coaches (family, friend, spouse) x 8 weeks relationships at the end of the intervention but not 8 1993 vs. structured support group weeks later. 1997 without coaches vs. control No effect on symptom distress or mood. (follow-up to 8 weeks) Kolcaba 53 Guided imagery audiotape vs. Audiotape use daily during radiation Intervention significantly improved comfort. 1999 control and for 3 weeks after (follow-up to 3 weeks post radiation) Walker 96 Relaxation and guided imagery Daily for 6 Intervention enhanced overall HRQOL and reduced 1999 vs. standard care chemotherapy cycles emotional repression (overall, unhappiness). (follow-up to end of intervention) Wengström 134 Individual nursing intervention Weekly x 30 minutes Intervention led to fewer distress reactions but no 1999 based on Orem’s model for self- x 5 weeks difference in HRQOL or toxicity. 2001 care vs. standard care Intervention resulted in “Stronger motivation to be emotionally involved” in those over 59 years old. (follow-up to 3 months post intervention) 237

TABLE B-1 Randomized Trials in “Early” Breast Cancer 238 Citation n Intervention(s) Duration Outcomes Sandgren 62 Telephone-based individual Weekly x 4, then every No consistent effects of the intervention over time. 2000 cognitive–behavioral therapy vs. 2 weeks x 6 Borderline effects for stress (early benefit, late detriment), assessment only (each < 30 minutes) anxiety and confusion (benefit), physical role functioning (early detriment) and mental health (early benefit). (follow-up to 10 months) Bultz 36 Psycho-educational group for Weekly x 90–120 minutes No significant effects. 2000 partners of breast cancer patients x 6 weeks Borderline improvement in mood of partner (p=0.07) and vs. control breast cancer patients (p=0.06) 3 months after intervention. (follow-up to 3 months post intervention) Ritz 210 Advanced practice nursing Not specified Intervention led to reduced uncertainty at 1, 3, 6 months 2000 interventions (individual) vs. (but not at 12 months). control Effect greatest in unmarried women. Beneficial effect on mood at 1, 3 months in subgroup without a family history. (follow-up to 12 months) Fukui 50 Cognitive–behavioral group Weekly x 90 minutes Intervention significantly improved mood, vigor and 2000 therapy with muscle relaxation x 6 weeks fighting spirit coping at the end of the intervention. and guided imagery vs. control Effects were marginal at 6 months. No effect on depression or anxiety. (follow-up to 6 months)

TABLE B-1 Randomized Trials in “Early” Breast Cancer Citation n Intervention(s) Duration Outcomes Helgeson 312 Education group vs. Weekly x 60 minutes Education group resulted in enhanced vitality, mental 1999 Peer discussion group vs. x 8 weeks health and social functioning compared to peer 2000 Education and peer discussion discussion. 2001 group vs. control Education group resulted in above plus enhanced role functioning and reduced bodily pain compared to controls. No benefits observed for peer discussion. Effects “dissipated over time.” (follow-up for 48 months) Simpson 89 Structured group psychotherapy Weekly x 60 minutes Intervention reduced depression and severity of 2001 vs. control (self-study) x 6 weeks psychiatric symptoms and enhanced mood and HRQOL at 2 years (but not at earlier times). (follow-up for 2 years) Lev 53 Individual counseling plus Monthly x ? minutes Small to large effect sizes for HRQOL, psychiatric 2001 videotape plus self-care booklet x 5 months symptoms. vs. control (educational booklet) No statistical significance testing. (follow-up to 8 months) Antoni 100 Structured cognitive–behavioral Weekly x 2 hours No overall effects. 2001 group intervention vs. 1 day x 10 weeks Intervention reduced the prevalence of moderate seminar (controls) depression and it increased benefit finding and optimism. (follow-up to 9 months post-intervention) 239

TABLE B-1 Randomized Trials in “Early” Breast Cancer 240 Citation n Intervention(s) Duration Outcomes Molassiotis 71 Progressive muscle relaxation Daily x 30 minutes Intervention reduced total mood disturbance, duration of 2002 training (individual session, audio x 6 days nausea and vomiting (trend to reduced frequency of and videotapes) vs. control nausea and vomiting). No effect on intensity of nausea and vomiting. (follow-up for 14 days) Allen 164 Individual problem skills training 6 sessions over 4 months No overall effects. 2002 vs. control (2 in person, 4 by telephone) Subgroup analysis indicated benefit in women with good baseline problem-solving ability. (follow-up for 8 months) Targ 181 Standard psychoeducational Standard – 12 sessions x 90 minutes Both interventions improved HRQOL and psychosocial 2002 group vs. mind–body–spirit weekly x 12 weeks functioning. (CAM) group CAM – 24 sessions x 150 minutes CAM led to greater spiritual integration and satisfaction. twice weekly x 12 weeks (follow-up for 12 weeks)

TABLE B-2 Randomized Trials in “Metastatic” Breast Cancer Citation n Intervention(s) Duration Outcomes Spiegel 86 Supportive–expressive group Weekly x 90 minutes Intervention improved mood, reduced maladaptive coping 1981 therapy vs. control x 1 year responses and phobias. 1983 Intervention prolonged survival (mean 36.6 vs. 18.9 1989 months intervention vs. control). (psychological follow-up x 12 months, survival > 10 years) Arathuzik 24 Individual structured relaxation 1 x 75 minutes No effects of intervention. 1994 and visualization with or without (relaxation and imagery alone) (same day follow-up) cognitive–behavioral therapy vs. written handouts about pain distraction Edelman 121 Group cognitive–behavioral Weekly x 8, Intervention improved mood and reduced depression, 1999 therapy vs. control monthly x 3, enhanced self-esteem. one family session Effects present at end of intervention but not 3 or 6 (each 2 hours) months later. No effect on survival. (follow-up 12 months for psychological outcomes, 2 to 5 years for survival) Edmonds 66 Supportive plus cognitive– Weekly x 2 hours Intervention subjects experienced more anxious- 1999 behavioral group therapy vs. x 35 weeks (longer in some women) preoccupied coping and less helplessness coping. Cunningham home cognitive–behavioral study plus one weekend No survival effects. 1999 program (psychological follow-up x 12 months, survival to > 5 years) 241

TABLE B-2 Randomized Trials in “Metastatic” Breast Cancer 242 Citation n Intervention(s) Duration Outcomes Classen 125 Supportive–expressive group Weekly x 90 minutes Intervention significantly reduced traumatic stress 2001 therapy vs. control to end of life symptoms – enhanced mood if final assessment during the year prior to death was excluded. Survival effects pending. (follow-up to 12 months) Goodwin 235 Supportive–expressive group Weekly x 90 minutes Intervention significantly enhanced overall mood, 2002 therapy vs. control to end of life depression, anxiety, anger, confusion and experience of pain. Intervention had no effect on survival. (follow-up to end of life)

TABLE B-3 Summary of the Effectiveness of Psychosocial Interventions in Breast Cancer I. Relaxation/Imagery* Duration of Duration of Duration of Citation Phase n Intervention Effectiveness Intervention Benefit Follow-up Bridge Early 154 Relaxation (audiotape) 6 weeks Improved mood, relaxation. 6 weeks 6 weeks 1988 Relaxation/Imagery Imagery and relaxation had additive effects. Richardson Early 47 Relaxation/Imagery group 6 weeks Greater acceptance of death, 6 weeks 6 weeks 1997 intervention enhanced coping – no effect on mood. Kolcaba Early 53 Guided imagery audiotape Radiation and 3 Improved “comfort”. 3 weeks 3 weeks 1999 weeks after post radiation post radiation Walker Early 96 Relaxation/guided imagery 6 cycles of Improved overall HRQOL To end of To end of 1999 (audiotape) chemotherapy Reduced emotional repression. chemotherapy chemotherapy Molassiotis Early 71 Progressive muscle relaxation 6 days Improved mood, reduced 14 days 14 days 2002 – audio and videotape duration and frequency but not intensity of nausea, vomiting. Arathuzik Metastatic 24 Relaxation plus visualization 1 session No effect. 1 day 1 day 1994 with or without cognitive– behavioral therapy * Does not include studies in which relaxation/hypnosis/imagery was delivered as a minor part of another intervention. 243

TABLE B-3 Summary of the Effectiveness of Psychosocial Interventions in Breast Cancer 244 II. Group Interventions Duration of Duration of Duration of Citation Phase n Intervention Effectiveness Intervention Benefit Follow-up Richardson Early 47 Non-structured support group 6 weeks Greater acceptance of death, 6 weeks 6 weeks 1997 enhanced coping Samarel Early 228 Structured support group with 8 weeks Coached groups resulted in 8 weeks 16 weeks 1992 or without coaches higher quality relationships 1993 1997 Helgeson Early 312 Education group 8 weeks Education group enhanced 48 months 48 months 1999 Education group plus peer vitality, mental health, social 2000 discussion group functioning, role functioning 2001 Peer discussion group and reduced bodily pain. No benefits of peer discussion. Effects “dissipated” over time. Simpson Early 89 Structured group 6 weeks Reduced depression and severity 24 months 24 months 2001 psychotherapy of psychiatric symptoms, enhanced mood and HRQOL Targ Early (<10% 181 Psychoeducational group 12 weeks Both groups improved measures 12 weeks 12 weeks 2002 metastatic) Mind–body–spirit group of HRQOL, psychosocial (CAM) function. CAM improved spiritual integration, satisfaction.

TABLE B-3 Summary of the Effectiveness of Psychosocial Interventions in Breast Cancer II. Group Interventions (continued) Duration of Duration of Duration of Citation Phase n Intervention Effectiveness Intervention Benefit Follow-up Spiegel Metastatic 86 Supportive–expressive group 1 year Improved mood, reduced 12 months 12 months 1981 therapy with relaxation maladaptive coping responses 1983 and phobias. 1989 Prolonged survival. Classen Metastatic 125 Supportive–expressive group Indefinite Reduced traumatic stress 12 months 12 months 2001 therapy with relaxation symptoms Enhanced mood if final measurement during the year prior to death excluded Goodwin Metastatic 235 Supportive–expressive group Indefinite Improved mood, reduced 12 months 12 months 2002 therapy with relaxation experience of pain Fukui Early 50 Cognitive–behavioral group 6 weeks Improved mood, vigor, fighting 8 weeks 6 months** 2000 with relaxation and guided spirit imagery Antoni Early 100 Structured cognitive– 10 weeks No overall effects _______ 9 months 2001 behavioral group Reduced prevalence of moderate depression, increased benefit finding/optimism Edelman Metastatic 121 Cognitive–behavioral group 5 months Improved mood, reduced 5 months 11 months 1999 depression, enhanced self-esteem ** Marginal effect at 6 months. 245

TABLE B-3 Summary of the Effectiveness of Psychosocial Interventions in Breast Cancer 246 III. Individual Interventions Duration of Duration of Duration of Citation Phase n Intervention Effectiveness Intervention Benefit Follow-up Edmonds Metastatic 66 Supportive plus cognitive– 35 weeks Increased anxious-preoccupied 12 months 12 months 1999 behavioral coping, reduced helplessness, Cunningham coping “Little psychometric 1999 effects” Cimprich Early 32 Individualized intervention to ? (short-term) Enhanced attentional capacity 90 days 90 days 1988 restore attentional capacity Burton Early 200 Psychological interview 1 day Psychological interview led to 1 year 1 year 1995 Psychological interview plus lasting reduction in body image psychotherapy distress, overall distress, anxiety, Psychological interview plus depression, enhanced fighting chat spirit. Psychotherapy beneficial among women with stressful life events. Maunsell Early 259 Telephone screening for 12 months No effects. _______ 1 year 1996 distress Marchioro Early 36 Cognitive–behavioral ? (short-term) Improved depression and quality 9 months 9 months 1996 counseling of life. Maguire Early 172 Nurse specialist counseling “Until woman Increased recognition of need for 12 to 18 months 12 to 18 months 1980 had adapted psychiatric referral. 1983 well” Psychiatric intervention reduced morbidity.

TABLE B-3 Summary of the Effectiveness of Psychosocial Interventions in Breast Cancer III. Individual Interventions (continued) Duration of Duration of Duration of Citation Phase n Intervention Effectiveness Intervention Benefit Follow-up McArdle Early 272 Nurse specialist support ? Nurse specialist led to improved 12 months 12 months 1996 Voluntary organization support somatic symptoms, social Both dysfunction and depression. Neither Wengström Early 134 Nursing intervention based on 5 weeks Fewer distress reactions, stronger 3 months 3 months 1999 Orem’s model for self-care motivation to be emotionally 2000 involved. 2001 Sandgren Early 62 Telephone-based cognitive– 16 weeks No consistent effects. 10 months 10 months 2000 behavioral therapy Borderline effects on stress, anxiety, confusion, physical role functioning and mental health varied over time. Ritz Early 210 Advanced practice nursing ? Reduced uncertainty (especially 3 to 6 months 12 months 2000 interventions in unmarried women). Beneficial early effect on mood in those without a family history. Lev Early 53 Nurse counseling plus 5 months No significance testing “Small to 8 months 8 months 2001 videotape plus self-care large effect sizes for HRQOL, booklet psychiatric symptoms”. Allan Early 164 Problem-solving skills training 4 months No overall effects. 8 months 8 months 2002 (2 session in person, 4 by Subgroup analysis suggested telephone) benefit in women with good problem-solving skills. 247

248 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-4 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Bridge LR, Benson P, Pietroni PC, Priest RG. Title: Relaxation and imagery in the treatment of breast cancer. Journal: British Medical Journal 1988; 297:1169–1172. Category: ( ) Education ( ) Individual Therapy (X) Relaxation/Hypnosis/Imagery (..) Group Therapy ( ) Behavioral Therapy/CBT (..) Other Setting: UK – Middlesex Hospital, London Study Design: RCT (1) Relaxation (2) Relaxation plus Imagery (3) Attention control Phase/Stage of Disease: Stage I or II during local radiotherapy. Number of Subjects: 154 Dropouts: 15 Compliance: Not stated Intervention: (1) Structured relaxation techniques + diaphragmatic breathing + audiotape (2) Above + imagery of peaceful scene (3) Controls encouraged to talk about themselves # Sessions: 30 min Duration: Weekly x 6 Measures: (1) Profile of Mood States (POMS) (2) Leeds General Scales (anxiety and depression) Time of Administration: Pre and post-intervention. Analysis: ANCOVA Relaxation with imagery better than relaxation alone for total mood disturbance (POMS). Results: Both interventions arms better than attention control arm. Same pattern for “relaxed” item in POMS. No differences for Leeds General Scales. Comments:

APPENDIX B 249 BOX B-5 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Cimprich B. Title: Development of an intervention to restore attention in cancer patients. Journal: Cancer Nursing 1993; 16:83–92. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (..) Group Therapy ( ) Behavioral Therapy/CBT (..) Other ] Setting: United States – University Medical Center Study Design: RCT (1) “Restorative intervention (2) Control Phase/Stage of Disease: Newly diagnosed Stage I or II breast cancer Number of Subjects: 32 Dropouts: 6 Compliance: Restorative intervention Intervention: – individualized protocol to identify experiences/practices that engage fascination or have other restorative properties – included a written contract and serial observations # Sessions: ? Duration: 20-30 minutes z 3 weeks x ? weeks Measures: (1) Digital Span (2) Leeds General Scales (anxiety and depression) Time of Administration: Baseline, 18, 60, 90 days post surgery Analysis: ANCOVA Results: Intervention significantly improved attentional capacity (AFI) and total attentional score. Comments:

250 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-6 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Maguire P, Tait A, Brooke M, Thomas C, Sellwood R. Title: Effect of counselling on the psychiatric morbidity associated with mastectomy. Journal: British Medical Journal 1980; 281:1454–1456. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (..) Group Therapy ( ) Behavioral Therapy/CBT (..) Other Setting: United Kingdom – University associated hospital “Pseudo RCT” – randomization of weeks in a 24 month period to: Study Design: (1) specialist nursing intervention versus (2) control according to week of admission for surgery. * Awareness of randomization may have influenced admission date. Phase/Stage of Disease: Breast cancer patients admitted for mastectomy Number of Subjects: 172 Dropouts: 20 Compliance: 3 not stated Intervention: Individual counseling by RN before/after surgery in hospital and at subsequent home visits every 2 months until women had “adapted well” – focus on scar, arm morbidity, breast prosthesis, openness re: effect of surgery. # Sessions: Variable Duration: Variable Measures: (1) Present State Exam (interviewer administered) (2) LASA’s – mood (self-report) (3) Brown-Birley Life Events Schedule (short version – interviewer administered) Time of Administration: (1) Postoperative, (2) three months later, (3) 12-18 months later Analysis: Not stated Results: “Counseling failed to prevent morbidity but the nurses’ regular monitoring of the women’s progress led nurse to recognize and refer 76% of those who needed psychiatric help” (vs. only 15% of control group). subsequent intervention reduced psychiatric morbidity at 12-18 months (also reduced anxiety and depression LASA scores). See also: Maguirre P, Brooke M, Tait A, Thomas C, Sellwood R. The effect of counselling Comments: on physical disability and social recovery after mastectomy. Clinical Oncology 1983; 9:319–324.

APPENDIX B 251 BOX B-7 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Christensen D. Title: Postmastectomy couple counseling: An outcome study of a structured treatment protocol. Journal: Journal of Sex and Marital Therapy 1983; 9:266–275. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (..) Group Therapy ( ) Behavioral Therapy/CBT (X) Other Couples therapy Setting: United States – multiple referral sources Study Design: RCT (couples randomized) Phase/Stage of Disease: Post mastectomy Number of Subjects: 20 couples Dropouts: Compliance: Intervention: Structured couples intervention based on work by Mildred Witlen – specifies tailored to each couple’s needs – focus on impact of mastectomy on couple’s relationship. # Sessions: 4 x ? time Duration: Weekly x 4 weeks Measures: (1) Psychological Screening Inventory (PSI) (2) Beck Depression Inventory (BDI) (3) Spielberger State/Trait Anxiety Inventory (STAI) (4) Lowenberg Self-Esteem Scale (5) Sexual Satisfaction Scale (6) Locke-Wallace Marital Adjustment Test (7) Internal-External Locus of Control Scale, Revised Time of Administration: 1 week before and 1 week after intervention Analysis: ANOVA No overall treatment effects identified. Results: adjusted analyses suggested tentative benefit for sexual satisfaction (husbands and wives), depression (wives), PSI (husbands and wives). Comments:

252 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER Box B-8 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Burton MV, Parker RW, Farrell A, Bailey D, Conneely J, Booth S, Elcombe S. Title: A randomized controlled trial of preoperative psychological preparation for mastectomy. Journal: Psycho-Oncology 1995; 4:1–19. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (..) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United Kingdom – Coventry Health Authority Study Design: RCT (1) Pre-operative interview (2) Pre-operative interview + 30 minutes psychotherapy (3) Pre-operative interview + 30 minutes chat (4) Routine care Phase/Stage of Disease: Pre-mastectomy (day before) Number of Subjects: 200 Dropouts: ? Compliance: 80 declined intervention Intervention: (1) Interview – psychologist – Present State Exam – focus on worries, concerns, beliefs (2) Interview + Psychotherapy – effect of illness on life situation, feelings (3) Interview + Chat – hobbies, holidays # Sessions: 1 or 2 (same day) Duration: - Pre-operative interview 45 minutes - Psychotherapy or chat 30 minutes Measures: (1) Present State Examination (shortened)/Interview – assessed depression, coping, stressful life events, social support, body image distress (2) Hospital Anxiety and Depression Scale Time of Administration: (1) Pre-intervention (except controls) (2) 3 months (3) 1 year Analysis: ANOVA Results: Pre-operative interviews (vs. control) - lasting reduction in body image distress – reduced overall distress, anxiety, depression, upset re: loss of breast, enhanced fighting spirit coping. Psychotherapy (vs. chat) superior among patients with stressful life events. (Interpret with caution – no baseline control data) Comments: Control group not informed of study until final measurement. No baseline data on controls; therefore, control group results may not be comparable to the intervention group at baseline.

APPENDIX B 253 BOX B-9 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Maunsell E, Brisson J, Deschênes L, Frasure-Smith N. Title: A randomized trial of a psychologic distress screening program after breast cancer: effects on quality of life. Journal: Journal of Clinical Oncology 1996; 14:2747–2755. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (..) Group Therapy ( ) Behavioral Therapy/CBT (X) Other Telephone distress screening Setting: Canada – University affiliated hospital Study Design: RCT (1) Monthly telephone screening of distress (2) Routine care (includes brief social work contact at diagnosis) Phase/Stage of Disease: Newly diagnosed “localized or regional stage” disease Number of Subjects: 259 Dropouts: 9 Compliance: 11.2 of 12 calls Intervention: Telephone screening q 28 days based on General Health Questionnaire – if score 5, patient’s social worker intervened by telephone to confirm distress, ascertain cause and offer additional contact. (Screening performed by a research assistant) # Sessions: 12 x 7.6 minutes Duration: Monthly x 12 Measures: (1) Social Support Questionnaire (2) Life Experiences Survey (3) Locke-Wallace Marital Adjustment Test (4) Psychiatric Symptom Index (5) Canada Health and Activity Limitation Survey Time of Administration: Baseline, 3, 12 months Analysis: Repeated Measures ANOVA Results: No significant effects. Comments:

254 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-10 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Marchioro G, Azzarello G, Checchin F, Perale M, Segati R, Sampognaro E, Rosetti F, Franchin A, Pappagallo GL, Vinante O. Title: The impact of a psychological intervention on quality of life in non-metastatic breast cancer. Journal: European Journal of Cancer 1996; 32A:1612–1615. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (..) Group Therapy (X) Behavioral Therapy/CBT ( ) Other Setting: Italy – setting not specific Study Design: RCT (1) Weekly cognitive individual therapy and bimonthly family counseling. (2) Standard care Phase/Stage of Disease: Newly diagnosed, non-metastatic breast cancer Number of Subjects: 36 Dropouts: Not stated Compliance: Not stated Intervention: Individual cognitive psychotherapy aimed at problems related to cancer diagnosis and therapy, anxiety or depression; loss of behavioral or emotional control; altered cognitive functioning; social and role limitations. # Sessions: ? x 50 min Duration: Weekly x ? Measures: (1) Beck Depression Inventory (2) Functional living Index cancer (3) 16-PF – A form (personality) (4) Interx Introject Questionnaire. Time of Administration: Baseline, 1, 3 6, 9, months Analysis: Repeated measures ANOVA Results: Intervention improved depression and quality of life. Changes in personality factors noted. Comments:

APPENDIX B 255 BOX B-11 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Richardson MA, Post-White J, Grimm EA, Moye LA, Singletary SE, Justice B. Title: Coping, life attitudes, and immune responses to imagery and group support after breast cancer treatment. Journal: Alternative Therapies in Health and Medicine. 1997; 3:62–71. Category: ( ) Education ( ) Individual Therapy (X) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States – University associated cancer center Study Design: RCT (1) Support groups (2) Imagery/relaxation group (3) Standard care Phase/Stage of Disease: Stage I-III Number of Subjects: 47 Dropouts: 0 Compliance: 8 attended < 50% Support Group – nonstructured, supportive – stress reduction, reducing feelings of Intervention: isolation, enhancing self-esteem. Imagery/Relaxation Group – relaxation, imagery, and basic breathing – audiotapes, discussion of stress, coping (one individual session). # Sessions: 6 x 1 hour Duration: Weekly x 6 weeks Measures: (1) Ways of Coping – Cancer (2) Life Attitude Profile (3) Functional Assessment of Cancer Treatment – Breast (4) Profile of Mood States (5) Duke UNC Functional Social Support Questionnaire (6) NK cytotoxicity (7) Cytokines (8) Beta endorphins. Time of Administration: Pre-test, Post-test Analysis: ANOVA Results: Enhanced coping skills in support (p <0.01) and imagery groups (p < 0.07); women in both interventions sought more support from others. Greater acceptance of death in support group (p < 0.01). No difference in mood or QOL or immune parameters. No significant differences between support and imagery groups. Comments: Pilot Study

256 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-12 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Samarel N, Fawcett J, Tulman L. Title: Effect of support groups with coaching on adaptation to early stage breast cancer. Journal: Research in Nursing and Health 1997; 20:15–26. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States Study Design: RCT - reassignment of women permitted in the 2 intervention arms (1) Support groups with coaching (2) Support group alone (3) Control Note: Some patients randomized to the intervention arms were re-randomized for logistical reasons. Phase/Stage of Disease: Stage I or II breast cancer surgically treated in the previous 4 months Number of Subjects: 228 Dropouts: 47 Compliance: (1) Structured support group designed to assist women to adapt in physiological, self- Intervention: concept, role function and interdependent response modes – patients and a coach (2) Support group without coaches (3) No treatment # Sessions: 8 x 2 hours Duration: Weekly x 8 weeks Measures: (1) Symptom Distress Scale (2) Profile of Mood States (3) Inventory of Functional Status – Cancer (4) Relationship Change Scale Time of Administration: (1) Baseline (2) End of group intervention (3) 8 weeks later Analysis: Repeated measures MANOVA, ANOVA Results: Support group with coaching resulted in higher quality relationships at the end of the group but not 8 weeks later. Interventions had no effect on symptom distress, mood or functional status. See also: Comments: (1) Samarel N, Fawcett J, Tulman L. The effects of coaching in breast cancer support groups: A pilot study. Oncology Nursing Forum 1993; 20:795–798. (2) Samarel N, Fawcett J. Enhancing adaptation to breast cancer: The addition of coaching to support groups. Oncology Nursing Forum 1992; 19:591–596.

APPENDIX B 257 BOX B-13 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Kolcaba K, Fox C. Title: The effects of guided imagery on comfort of women with early stage breast cancer undergoing radiation therapy. Journal: Oncology Nursing Forum 1999; 26:67–72. Category: ( ) Education ( ) Individual Therapy (X) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States – mid-western radiation and oncology departments Study Design: RCT (1) Guided imagery audiotape (2) Control Phase/Stage of Disease: Stage I or II breast cancer patients about to begin radiation therapy Number of Subjects: 53 Dropouts: 3 Compliance: ? Intervention: Audiotape – 20 minutes of verbal guided imagery focusing on comfort – psychospiritual, environmental, social - plus 20 minutes of soft jazz music # Sessions: Not stated Duration: Daily during XRT and for 3 weeks after Measures: (1) State-Trait Anxiety Inventory – baseline only (2) Radiation Therapy Comfort Questionnaire (RTCQ) Time of Administration: Baseline, 3 weeks later, 3 weeks after radiation completed Analysis: Repeated measures ANOVA Results: Intervention significantly improved comfort across all three time periods. Comments: See also: Kolcaba KY. A taxonomic structure for the comfort concept. Image: Journal of Nursing Scholarship 1991; 23 237–240.

258 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-14 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Walker LG, Walker MB, Ogston K, Heys SD, Ah-See AK, Miller ID, Hutcheon AW, Sarkar TK, Eremin O. Title: Psychological, clinical and pathological effects of relaxation training and guided imagery during primary chemotherapy. Journal: British Journal of Cancer 1999; 80:262–268. Category: ( ) Education ( ) Individual Therapy (X) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United Kingdom – Aberdeen Royal Infirmary Study Design: RCT (1) Relaxation training and guided imagery. (2) Standard care Phase/Stage of Disease: Newly diagnosed locally advanced breast cancer (T2 > 4 cm,T3, T4 or N2, M0) Number of Subjects: 96 Dropouts: 10 (death progression) Compliance: 56% 1/day Intervention: Progressive muscular relaxation and cue-controlled relaxation Audiocassettes and cartoon images of host defenses destroying cancer cells (the first 40 women also received “live” training) – daily use # Sessions: Duration: Daily x 6 chemotherapy cycles Measures: (1) Courtauld Emotional Control Scale (2) Eysenck Personality Questionnaire (3) Rotterdam Symptom Checklist (4) Global Self-rated Quality of Life (5) Mood Rating Scale (6) Tumor size measurements Using calipers (7) Histological response Time of Administration: Variable – all before chemotherapy cycle 1, 6; MRS and RSCL before each cycle Analysis: MANCOVA Results: Intervention reduced emotional repression (overall, unhappiness). Intervention enhanced overall quality of life (RSCL, Global Self-rated QOL). No effect on mood. Comments: No effect on tumor size or histological response to chemotherapy.

APPENDIX B 259 BOX B-15 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Wengström Y, Häggmark C, Strander H, Forsberg C. Title: Effects of a nursing intervention on subjective distress, side effects and quality of life of breast cancer patients receiving curative radiation therapy. A randomized study. Journal: Acta Oncologica 1999; 38:763–770. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: Stockholm, Sweden – University Hospital Study Design: RCT (1) Intervention (2) Standard care Phase/Stage of Disease: Adjuvant – radiation therapy Number of Subjects: 134 Dropouts: 1 (control) Compliance: ? Intervention: Nursing intervention based on Orem’s model for self-care – individual contact – education, support and guidance re: self-care, psychological support and coping strategies + body image + treatment # Sessions: 5 x 30 minutes Duration: Weekly x 5 weeks Measures: (1) Impact of Events Scale (2) Cancer Rehabilitation Evaluation System (CARES-sf ) (3) Oncology Treatment Toxicity Assessment Tool (4) Wheel Questionnaire Time of Administration: (1) prior to XRT (2) 3 weeks into XRT (3) 2 weeks post XRT (4) 3 months post XRT Analysis: Repeated measures ANOVA, t-tests Results: Intervention group had fewer distress reactions (IES) – there were no effects on QOL (CARES) or toxicity (OTTAT). Intervention resulted in “stronger motivation to be emotionally involved” in women >59 years old. Comments: See also: Wengström Y, Häggmark C, Forsberg C. Coping with radiation therapy: Effects of a nursing intervention coping ability for women with breast cancer. International Journal of Nursing Practice 2001; 7:8–15.

260 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-16 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Sandgren AK, McCaul KD, King B, O’Donnell S, Foreman G. Title: Telephone Therapy for Patients with Breast Cancer. Journal: Oncology Nursing Forum 2000; 4:683–688 Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery ( ) Group Therapy (X) Behavioral Therapy/CBT ( ) Other Setting: United States – Tertiary cancer center Study Design: RCT (1) Telephone based cognitive–behavioral therapy (individual) (2) Assessment only Phase/Stage of Disease: Stage I, II – within 3-4 months of diagnosis. Number of Subjects: 62 Dropouts: 5 Compliance: 90% (17 randomized women declined participation) Intervention: Telephone support, coping skills, managing anxiety and stress, solving patient-generated problems – using cognitive restructuring – encouragement of emotional expression, diaphragmatic breathing. weekly x 4 # Sessions: Duration: 30 minutes (average 20-25) q 2 weekly x 6 Measures: (1) Profile of Mood States (2) Medical Outcome Scales SF 36 (3) Perceived Stress (4) Satisfaction with therapy (5) Coping Response Indices - Revised Time of Administration: Baseline, 4 and 10 months follow-up Analysis: ANOVA, t-tests No consistent effects of intervention over time. Results: Some borderline effect of interaction for stress (early benefit, late detriment) anxiety and confusion (benefit), physical role functioning (early detriment), mental health (early benefit) Intervention subjects used oncology nursing telephone line more. Comments: ? Pre-consent randomization

APPENDIX B 261 BOX B-17 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Bultz BD, Speca M, Brasher PM, Geggie PHS, Page SA. Title: A randomized controlled trial of a brief psychoeducational support group for partners of early stage breast cancer patients. Journal: Psycho-Oncology 2000; 9:303–313. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: Canada – University affiliated Regional Cancer Center Study Design: RCT (1) Psychoeducational group for breast cancer partners (2) Control Phase/Stage of Disease: Stage I or II diagnosed within the past year. Number of Subjects: 36 couples Dropouts: 2 couples Compliance: 31/34 – 100% attendance Intervention: Psycho-education – first 2 sessions educational, last 4 unstructured Focus on feelings, fears, strengthening relationships # Sessions: 6 Duration: Weekly x 1.5 to 2 hours Measures: (1) Profile of Mood States (2) Index of Marital Satisfaction (3) Duke – UNC Functional Social Support Scale (4) Mental Adjustment to Cancer Scale. Time of Administration: Pre and post-intervention, 3 months later Analysis: ANCOVA No statistically significant effects. Results: Author states intervention improved mood in partners at 3 months (p = 0.07) [wives’ mood also improved (p = 0.06)]. Comments:

262 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-18 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Ritz LJ, Nissen MJ, Swenson KK, Farrell JB, Sperduto PW, Sladek ML, Lally RM, Schroeder, LM. Title: Effects of advanced nursing care on quality of life and cost outcomes of women diagnosed with breast cancer. Journal: Oncology Nursing Forum 2000; 6:923–932. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States – Health care setting not described Study Design: RCT (1) Advanced Practice Nursing Interventions (2) Control Phase/Stage of Disease: Within 2 weeks of diagnosis (invasive, and non-invasive breast cancer) Number of Subjects: 210 Dropouts: ? Compliance: ? Written and verbal information about breast cancer; what to expect in consultation with Intervention: physicians’ decision, making support, answering questions, continuity of care (in person, by telephone, during home visits) # Sessions: Not specified Duration: Not specified Measures: (1) Functional Assessment of Cancer Therapy – Breast (2) Mishel Uncertainty in Illness Scale (3) Profile of Mood States Time of Administration: Baseline and 1, 3, 6, 12, 24 months later Analysis: Multiple regression models for repeated measures Results: Intervention reduced uncertainty at 1, 3, 6 months (greatest effect in unmarried women) – overall and complexity, inconsistency and unpredictability subscales. No effect on mood overall benefit at 1, 3 months and in women without a family history. No effect on QOL. Comments: No effect on health-care costs.

APPENDIX B 263 BOX B-19 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Fukui S, Kugaya A, Okamura H, Kamiya M, Koike M, Nakanishi T, Imoto S, Kanagawa K, Uchitomi Y. Title: A psychosocial group intervention for Japanese women with primary breast carcinoma. A randomized controlled trial. Journal: Cancer 2000; 89:1026–1036. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: Japan – National Cancer Center Study Design: RCT (1) Cognitive–behavioral Group Therapy (2) Wait list controls Phase/Stage of Disease: High risk invasive breast cancer diagnosed 4-18 months before – no chemotherapy Number of Subjects: 50 Dropouts: 4 Compliance: Group cognitive behavioral therapy – education, coping skills training, stress management Intervention: (including muscle relaxation and guided imagery), psychosocial support 6 to 10 patients, 2 therapists – structured. # Sessions: 6 x 90 minutes Duration: Weekly x 6 Measures: (1) Hospital Anxiety and Depression Scale (2) Mental Adjustment to Cancer Scale (3) Profile of Mood States Time of Administration: Baseline, 6 weeks (end of intervention), 6 months Analysis: ANCOVA Results: Intervention significantly improved vigor and overall mood at the end of the intervention; effect marginal 6 months later. Intervention significantly enhanced Fighting Spirit Coping at the end of the intervention; effect marginal 6 months later. No significant effect on depression or anxiety. Comments:

264 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-20 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Helgeson VS, Cohen S. Title: Long-term effects of educational and peer discussion group interventions on adjustment to breast cancer. Journal: Health Psychology 2001;20:387-392. Category: (X) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT (X) Other Peer discussion Setting: United States (Pittsburgh) – oncology offices Study Design: RCT (1) Control (2) Education (3) Peer Discussion (4) Education and peer discussion (Factorial design) Phase/Stage of Disease: Prior to or early into adjuvant chemotherapy (Stage I to III) Number of Subjects: 312 Dropouts: 2% Compliance: 62.5% Intervention: (1) Education – group – lecture + questions/answers; expert presenter and oncology RN/MSW – interaction inhibited (2) Peer Discussion – group – MSW/RN facilitation (did not direct) – focus on expression of feelings/self disclosure # Sessions: 8 x 60 minutes Duration: Weekly x 8 Measures: (1) MOS SF-36 (2) Positive and Negative Affect Scale (3) Impact of Events Scale (4) Rosenberg Self-Esteem Scale (5) CARES (6) Interview Time of Administration: Pre-R; 1-2 weeks post interview; 6, 12, 24, 48 months post Analysis: Intent to treat – Repeated measures ANOVA Excluded 54 women who recurred before last measurement. Results: Education vs. control: enhanced vitality, social function, mental health, reduced bodily pain; short term enhanced role functioning. Education vs. peer discussion – enhanced vitality, mental health, social functioning. No benefits for peer discussion (early or late). Effects of intervention “dissipated over time”. See also: Comments: (1) Helgeson VS, Cohen S, Schulz R, Yasko J. Education and peer discussion group interventions and adjustment to breast cancer. Archives of General Psychiatry 1999; 56:340–347. (2) Helgeson VS, Cohen S, Schulz R, Yasko J. Group support interventions for women with breast cancer: Who benefits from what? Health Psychology 2000; 19:107–114.

APPENDIX B 265 BOX B-21 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Simpson JSA, Carlson LE, Trew ME. Title: The effect of group therapy for breast cancer on healthcare utilization. Journal: Cancer Practice 2001; 9:19–26. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: Alberta (Canada) Study Design: RCT (1) Group Intervention (2) Control – “Self-initiated studies” Phase/Stage of Disease: Stage 0-2; treatment completed up to 2 years before study entry Number of Subjects: 89 Dropouts: ? Compliance: ? Intervention: (1) Intervention – structured group psychotherapy with weekly themes – one therapist, 2 “survivor” leaders and 7 to 10 subjects (2) Control – self-study, “Helping Yourself – A Workbook for People Living with Cancer” # Sessions: 6 x 90 minutes Duration: Weekly x 6 weeks Measures: (1) Profile of Mood States (2) Mental Adjustment to Cancer (3) Beck Depression Inventory (4) Symptom Checklist – SCL 90R (5) Dealing with Illness Inventory (6) DS MIII R SCI D (structured clinical interview). Time of Administration: Baseline; post-intervention, 1 and 2 years (except SCID) Analysis: t-tests at each timepoint Repeated measures GLM Results: Reduced depression, enhanced mood, QOL post-intervention and at 2 years follow-up (but not at one year) in intervention subjects. Lower severity of psychiatric symptoms at 2 years in intervention subjects (results similar using repeated measures and t-tests). Comments: Health care billing $147 less in intervention subjects (23.5% reduction) compared to controls.

266 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-22 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Lev EL, Daley KM, Conner NE, Reith M, Fernandez C, Owens SV. Title: An intervention to increase quality of life and self-care self-efficacy and decrease symptoms in breast cancer patients. Journal: Scholarly Inquiry for Nursing Practice: An International Journal 2001; 15:277–294. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT (X) Other Self –efficacy intervention Setting: United States Study Design: RCT (1) Efficacy enhancing intervention (2) Control – Educational booklet on cancer chemotherapy Phase/Stage of Disease: Stage I or II – within first cycle of chemotherapy Number of Subjects: 53 Dropouts: 27 Compliance: Intervention: (1) 5 minute videotape (2) Self-care behavior booklet (3) 5 efficacy-enhancing counseling interventions at one month intervals (individual) # Sessions: 5 x ? minutes Duration: Monthly x 5 months Measures: (1) Functional Assessment of Cancer Treatment - Breast (2) Symptom Distress Scale (3) Strategies Used by Patients to Promote Health (SUPPH) Time of Administration: Baseline, 4 and 8 months Analysis: No formal tests of statistical significance – reported effect sizes only Results: Small (functional concerns) to large (social concerns) effect sizes for FACT-B. Large effect sizes for SDS. Small (Enjoying Life, Stress Reduction) to large (Making Decisions) effect sizes for SUPPH. Comments: Interpretation of results difficult because of high dropout rate and lack of statistical significance testing.

APPENDIX B 267 BOX B-23 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Antoni MH, Lehman JM, Kilbourn KM, Boyers AE, Culver JL, Alferi SM, Yount SE, McGregor BA, Arena PL, Harris SD, Price AS, Carver CS. Title: Cognitive–behavioral stress management intervention decreases the prevalence of depression and enhances benefit finding among women under treatment for early-stage breast cancer. Journal: Health Psychology 2001; 20:20–32. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy (X) Behavioral Therapy/CBT ( ) Other Setting: United States Miami – several hospitals and medical practices RCT (only the 73.5% who completed all assessments were included in the analysis) Study Design: (1) Intervention (2) Control Phase/Stage of Disease: Stage 0-2; within 8 weeks of surgery 86.5% (Intervention) Number of Subjects: 100 Dropouts: 26.5% Compliance: 75.5% (Control) Intervention: (1) Cognitive–behavioral stress management - structured group intervention weekly for 2 hours x 10 weeks - didactic/experiential exercises + homework - several areas of emphasis (2) Control – 1 day seminar 16-18 weeks post operatively # Sessions: 10 x 2 hours Duration: Weekly x 10 weeks Measures: (1) Profile of Mood States – SF (2) Center for Epidemiologic Studies – Depression (3) Impact of Events Scale (4) Life Orientation Test – Revised (5) Novel Measures of Perceived Benefits and Emotional Processing Time of Administration: Baseline, post intervention, 3 and 9 months post intervention Analysis: Multiple techniques Results: No overall effects. Intervention reduced the prevalence of moderate depression, increased benefit finding and optimism (maximum effect in women with low baseline optimism scores). Many secondary analyses presented. Comments: Only the 100 women who completed all assessments were included in the analysis.

268 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-24 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Molassiotis A, Yung HP, Yam BMC, Chan FYS, Mok TSK. Title: The effectiveness of progressive muscle relaxation training in managing chemotherapy- induced nausea and vomiting in Chinese breast cancer patients: A randomised controlled trial. Journal: Support Care Cancer 2002; 10:237–246. Category: ( ) Education ( ) Individual Therapy (X) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: Hong Kong – outpatient oncology department of university hospital Study Design: RCT (1) Intervention (2) Control Phase/Stage of Disease: Stage I-III; first cycle of AC chemotherapy Number of Subjects: 71 Dropouts: 0 Compliance: 100% Progressive muscle relaxation training – 6 standardized sessions (25 minutes relaxation, 5 Intervention: minutes imagery) with therapist (1 hour before chemo, days 1 to 5 post chemo) + individual audiocassettes + 30 minute video teaching program. # Sessions: 6 x 30 minutes Duration: Daily x 6 days Measures: (1) Profile of Mood States (2) State-Trait Anxiety Inventory (3) Morrow Assessment of Nausea and Vomiting Scale (MANV) Time of Administration: (1) and (2) Baseline, 7 and 14 days post chemotherapy; (3) daily x 7 Analysis: Repeated measures ANOVA Results: POMS – significant decrease in total mood disturbance (not anxiety) with intervention. MANV – significant decrease in duration of nausea and vomiting with intervention – trend to lower frequency of nausea and vomiting with intervention (no effect on intensity of nausea and vomiting). Comments:

APPENDIX B 269 BOX B-25 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Allen SM, Shah AC, Nezu AM, Nezu CM, Ciambrone D, Hogan J, Mor V. Title: A problem-solving approach to stress reduction among younger women with breast carcinoma. Journal: Cancer 2002; 94:3089–3100. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States – 31 private oncology practices, 4 hospitals departments Study Design: RCT (1) Intervention (2) Control Phase/Stage of Disease: Adjuvant Chemotherapy Stage I-IIIA Number of Subjects: 164 (<50 years old) Dropouts: 9% Compliance: Not stated Intervention: Problem-solving skills training based on “Home Care Guide for Women with Breast Cancer” 5 interactive components individualized worksheets focus on problem-solving. 6 (2 in person x 2 hours each; # Sessions: Duration: Approximately 3 months 4 telephone calls Measures: (1) Cancer Rehabilitation Evaluation System (2) MH 1-5 (Mental Health Inventory) (3) Impact of Events Scale, Social Problem-Solving Inventory (Revised) (4) Unmet Needs for Assistance Time of Administration: Baseline; 4 and 8 months post baseline Analysis: ANOVA; multivariate analyses Results: No overall significant differences (univariate or multivariate). Subgroups: Good baseline problem-solving ability – significant decrease in number and severity of difficulties experienced. Poor baseline problem-solving ability – no effect. Comments: Effect of intervention differed according to baseline problem-solving ability in post-hoc analyses.

270 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-26 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Spiegel D, Bloom JR, Yalom I. Title: Group support for patients with metastatic breast cancer. A randomized prospective outcome study. Journal: Archives of General Psychiatry 1981; 38:527–533. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States – University affiliated medical center Study Design: RCT (1) Support Group (2) Control Phase/Stage of Disease: Metastatic Number of Subjects: 86 Dropouts: 28 Compliance: ? Supportive–expressive group therapy: 7-10 women and 2 leaders – primary supportive – focus Intervention: on content (death, dying, family problems, treatment, communication, living richly in face of terminal illness). # Sessions: Weekly x 90 minutes Duration: Weekly x 1 year (or longer) Measures: (1) Profile of Mood States (2) Health Locus of Control (3) Janis-Field Self-Esteem Scale (4) Maladaptive Coping Response (5) Phobia Checklist (6) Denial measure Time of Administration: Baseline, 4, 8, 12 months Analysis: Slopes analysis (psychological measures), Cox proportional hazards model (survival) Results: Intervention improved mood, reduced maladaptive coping responses, reduced phobias and prolonged survival (mean 36.6 months in intervention group, 18.9 months in controls). Comments: See also: (1) Spiegel D, Bloom JR. Pain in metastatic breast cancer. Cancer 1983; 52:341–345 . (2) Spiegel D, Bloom, JR, Kraemer H, Gottheil E. Effects of psychosocial treatment on survival of patients with metastatic breast cancer. Lancet 1989; 2:888–891.

APPENDIX B 271 BOX B-27 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Arathuzik D. Title: Effects of cognitive–behavioral strategies on pain in cancer patients. Journal: Cancer Nursing 1994; 17:207–214. Category: ( ) Education ( ) Individual Therapy (X) Relaxation/Hypnosis/Imagery ( ) Group Therapy (X) Behavioral Therapy/CBT ( ) Other Setting: United States Boston – community and university hospitals RCT (pilot) Study Design: (1) relaxation/visualization (2) relaxation/visualization + cognitive–behavioral (3) control Phase/Stage of Disease: Metastatic breast cancer. Number of Subjects: 24 Dropouts: 0 Compliance: 100% Intervention: (1) Structured relaxation and visualization – individual sessions, progressive relaxation/visualization (2) CBT – individual – pain distraction – written handout describing 23 methods of distraction Relaxation/visualization – 75 minutes # Sessions: 1 Duration: Relaxation/visualization + CBT – 120 minutes Measures: (1) Profile of Mood States - B (2) Johnson Pain Intensity Distress Scale Time of Administration: Pre/post intervention; 2 consecutive days controls Analysis: ANOVA, t-tests No between group differences in pain intensity, distress, control or ability to decrease pain Results: or in mood. Both treatment groups increased perceived ability to decrease pain. Multiple within-group pre/post change identified. Comments:

272 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-28 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Edelman S, Bell DR, Kidman AD. Title: A group cognitive behaviour therapy programme with metastatic breast cancer patients. Journal: Psycho-Oncology 1999; 8:295–305. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy (X) Behavioral Therapy/CBT ( ) Other Setting: Australia – University associated hospital Study Design: RCT (1) CBT x 12 sessions (group) (2) Control Phase/Stage of Disease: Metastatic breast cancer Number of Subjects: 121 Dropouts: 28 Compliance: ? Intervention: Structured manual based homework exercises. Specific themes – cognitive restructuring, relaxation, communication and coping strategies, group interaction and support, relationships, self-image. # Sessions: 12 x ? 2 hours Duration: Weekly x 8, monthly x 3, one family session Measures: (1) Profile of Mood States (2) Coopersmith Self-Esteem Inventory – Adult Form (3) Survival Time of Administration: Baseline, completion of therapy; 3, 6, 12 months post intervention (12 month data not analysed) Analysis: Change scores – t-tests Cox Proportional Hazards Model (Survival) Results: No survival effects. Intervention improved mood (depression, total mood disturbance) and enhanced self-esteem at completion of therapy. No benefits at 3, 6 months. Comments: See also: Edelman S, Lemon J, Bell DR, Kidman AD. Effects of group CBT on the survival time of patients with metastatic breast cancer. Psycho-Oncology 1999; 8:474–481.

APPENDIX B 273 BOX B-29 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Edmonds CVI, Lockwood GA, Cunningham AJ. Title: Psychological response to long term group therapy: A randomized trial with metastatic breast cancer patients. Journal: Psycho-Oncology 1999; 8:74–91. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy (X) Behavioral Therapy/CBT ( ) Other Setting: Canada – University associated cancer center Study Design: RCT (1) Group intervention – supportive + CBT (2) Home cognitive – behavioral study package Phase/Stage of Disease: Metastatic breast cancer Number of Subjects: 66 Dropouts: 8 Compliance: 62.6% Intervention: (1) Group discussion, CBT assignments (20), coping skills weekend, relaxation (2) Home package – CBT/coping skills workbook, relaxation tapes, phone call at 2, 4, 5, 10, 12 months - supportive # Sessions: 35 x 2 hours Duration: Weekly x 35 weeks + one weekend Measures: (1) Survival (2) Profile of Mood States (3) Functional Living Index for Cancer (4) Duke UNC Functional Social Support Questionnaire (5) Mental Adjustment to Cancer Scale (6) Rationality/Emotional Defensiveness Scale (7) Marlow Crowne Social Desirability Scale (8) Defensive Repression Time of Administration: Baseline, 4, 8, 12 months Analysis: Change scores – t-tests/Mann-Whitney Tests (psychological) Cox Proportional Hazards analysis (Survival) Results: No survival effects. “Little” psychometric effects – intervention subjects experienced more anxious- preoccupation and less helplessness. Comments: See also: Cunningham AJ, Edmonds CVI, Jenkins GP, Pollack H, Lockwood GA, Warr D. A randomized controlled trial of the effects of group psychological therapy on survival in women with metastatic breast cancer. Psycho-Oncology 1998; 7:508–517.

274 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-30 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Classen C, Butler LD, Koopman C, Miller E, DiMiceli S, Giese-Davis J, Fobair P, Carlson RW, Kraemer HC, Spiegel D. Title: Supportive–expressive group therapy and distress in patients with metastatic breast cancer. Journal: Archives of General Psychiatry 2001; 58:494–501. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States – University associated hospitals Study Design: RCT (1) Supportive–expressive group therapy (2) Control (educational materials offered) Phase/Stage of Disease: Metastatic breast cancer (2 had local breast recurrences only) Number of Subjects: 125 Dropouts: 11 Compliance: 82% questionnaires Intervention: Supportive–expressive group therapy: 2 therapists – supportive environment in which participants encouraged to confront problems, strengthen relationships, find enhanced meaning in life – unstructured. # Sessions: Variable x 90 minutes Duration: Weekly to end of life Measures: (1) Profile of Mood States (2) Impact of Events Time of Administration: Baseline, every 4 months x 1 year, every 6 months thereafter Analysis: Slopes analysis Results: Intervention significantly reduced traumatic stress symptoms but had no significant impact on overall mood (effect enhanced if final assessment during the year before death excluded). Intervention significantly improved mood if final assessments performed during the year before death excluded. Comments: Survival data not yet mature.

APPENDIX B 275 BOX B-31 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Goodwin PJ, Leszcz M, Ennis M, Koopmans J, Vincent L, Guther H, Drysdale E, Hundleby M, Chochinov H, Navarro M, Speca M, Hunter J et al. Title: The effect of group psychosocial support on survival in metastatic breast cancer. Journal: New England Journal of Medicine 2002; 345:1719–1726. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: Canada – University associated cancer centers Study Design: RCT (1) Supportive–expressive Group Therapy (2) Usual Care Phase/Stage of Disease: Metastatic breast cancer Number of Subjects: 235 Dropouts: 19.0% Compliance: 66.7% Intervention: Supportive–expressive group therapy: 8-12 women, 2 leaders foster support, encourage emotional expressiveness, confront effects of illness, change in self-image, roles, relationships, life altering nature of illness, coping and communication. Monthly family sessions. # Sessions: Weekly sessions to death Duration: Weekly x 90 minutes Measures: (1) Profile of Mood States (2) Pain LASAs (3) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (4) Survival Time of Administration: Baseline, 4, 8, 12 months Analysis: Intervention to treat ANCOVA (psychological) Cox Proportional Hazards Model (survival) Results: No survival effects, no HRQOL effects. Enhanced mood (total mood, anger, anxiety, depression, confusion) in intervention subjects. Reduced experience of pain in intervention subjects. Comments: See also: Bordeleau L, Szalai JP, Ennis M, Leszcz M, Speca M, Sela R, Doll R, Chochinov HM, Navarro M, Arnold A, Pritchard KI, Bezjak A, Llewellyn-Thomas H, Sawka CA, Goodwin PJ. Quality of life in a randomized trial of group psychosocial support in metastatic breast cancer: overall effects of the intervention and an exploration of missing data. 2003. J Clin Oncol 21(10)1944:1951.

276 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-32 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Fogarty LA, Curbow BA, Wingard JR, McDonnell K, Somerfield MR. Title: Can 40 Seconds of Compassion Reduce Patient Anxiety? Journal: Journal of Clinical Oncology 1999; 17:371–379. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery ( ) Group Therapy ( ) Behavioral Therapy/CBT (X) Other Videotape Setting: United States – University Centres, local support groups Study Design: RCT (1) Enhanced compassion videotape (2) Standard videotape Phase/Stage of Disease: Healthy breast cancer survivors (> 6 months post diagnosis, no recurrence) Number of Subjects: 123 Dropouts: Compliance: Dramatized videotapes of a treatment consultation that did or did not enhance compassion – Intervention: verbal acknowledgement of psychologic concern, offer of support and partnership – touching of hand # Sessions: 1 Duration: 18 minutes Measures: (1) State Trait Anxiety Index (2) Physician compassion (3) Treatment information recall and (4)Hypothetical discussion (5) Perceptions of physicians attributes Time of Administration: Pre/post intervention Analysis: Multiple techniques Results: Reduced anxiety in Enhanced Compassion Group Reduced information recall in Enhanced Compassion Group. Differences in perception of compassion and physician attributes in expected direction. Comments: Women with no history of breast cancer participated, as a second randomized group results were similar to those in breast cancer survivors.

APPENDIX B 277 BOX B-33 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): McArdle JM, George WD, McArdle CS, Smith DC, Moodie AR, Hughson AVM, Murray GD. Title: Psychological support for patients undergoing breast cancer surgery: a randomised study Journal: British Medical Journal 1996; 312:813–817. Category: ( ) Education (X) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United Kingdom (Scotland) RCT Study Design: (1) Control (2) Support from breast cancer nurse (3) Support from voluntary organization (4) Support from nurse and organization Phase/Stage of Disease: At diagnosis – early stage breast cancer. Number of Subjects: 272 Dropouts: 50/272 Compliance: variable Support from breast cancer nurse – individual support, education, encouragement of Intervention: emotional expression; optional joint meeting with relatives Support from voluntary organization – individual and group counseling (transactional analysis), education # Sessions: Variable Duration: Not stated (1) General Health Questionnaire Measures: (2) Hospital Anxiety and Depression Scale Time of Administration: First postoperative visit; 3, 6, 12, months later Analysis: Intent to treat; Kruskal-Wallis, Mann-Whitney tests Support from breast cancer nurse resulted in improved somatic symptoms, social Results: dysfunction and depression. Support from nurse significantly better than voluntary organization for above on all measures. Comments:

278 MEETING PSYCHOSOCIAL NEEDS OF WOMEN WITH BREAST CANCER BOX B-34 Clinical Trials of Psychosocial Interventions in Breast Cancer Author(s): Targ EF, Levine EG. Title: The efficacy of a mind-body-spirit group for women with breast cancer: a randomized controlled clinical trial. Journal: General Hospital Psychiatry 2002; 24:238–248. Category: ( ) Education ( ) Individual Therapy ( ) Relaxation/Hypnosis/Imagery (X) Group Therapy ( ) Behavioral Therapy/CBT ( ) Other Setting: United States (San Francisco) RCT Study Design: (1) Mind-body-spirit (complementary and alternative medicine) support group (CAM) (2) Standard cognitive–behavioral therapy group Phase/Stage of Disease: Within 18 months of diagnosis; 10 had metastatic disease. Number of Subjects: 181 Dropouts: 51 Compliance: ? (dropouts greater in standard arm) CAM - Group support with emphasis on psychospiritual issues and inner process Intervention: with education and dance that taught meditations, affirmation, imagery and ritual Standard - Psychoeducational – coping, communication, problem-solving, emotional expression # Sessions: CAM 24/12 weeks Duration: CAM 2½ hours STD 12/12 weeks STD 1½ hours Measures: (1) Functional Assessment of Chronic Illness Therapy (2) Profile of Mood States (3) Principles of Living Survey Time of Administration: Pre, post Analysis: - MANOVA - Repeated Measures Analysis of Variance - Intent to Treat Results: - Both interventions improved many aspects of HRQOL and psychosocial functioning. - CAM resulted in enhanced spiritual integration, higher satisfaction and fewer dropouts. - Equivalence was seen for “most psychosocial outcomes.” Comments:

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In Meeting Psychosocial Needs of Women with Breast Cancer, the National Cancer Policy Board of the Institute of Medicine examines the psychosocial consequences of the cancer experience. The book focuses specifically on breast cancer in women because this group has the largest survivor population (over 2 million) and this disease is the most extensively studied cancer from the standpoint of psychosocial effects. The book characterizes the psychosocial consequences of a diagnosis of breast cancer, describes psychosocial services and how they are delivered, and evaluates their effectiveness. It assesses the status of professional education and training and applied clinical and health services research and proposes policies to improve the quality of care and quality of life for women with breast cancer and their families. Because cancer of the breast is likely a good model for cancer at other sites, recommendations for this cancer should be applicable to the psychosocial care provided generally to individuals with cancer. For breast cancer, and indeed probably for any cancer, the report finds that psychosocial services can provide significant benefits in quality of life and success in coping with serious and life-threatening disease for patients and their families.

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