Appendix B
Tables and Boxes Summarizing Evidence from Clinical Trials

Summary tables and detailed descriptions of clinical trials of the effectiveness 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



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Meeting Psychosocial Needs of Women with Breast Cancer Appendix B Tables and Boxes Summarizing Evidence from Clinical Trials Summary tables and detailed descriptions of clinical trials of the effectiveness 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

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

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

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

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Meeting Psychosocial Needs of Women with Breast Cancer Citation n Intervention(s) Duration Outcomes Sandgren 2000 62 Telephone-based individual cognitive–behavioral therapy vs. assessment only Weekly x 4, then every 2 weeks x 6 (each < 30 minutes) • No consistent effects of the intervention over time. • Borderline effects for stress (early benefit, late detriment), anxiety and confusion (benefit), physical role functioning (early detriment) and mental health (early benefit). (follow-up to 10 months) Bultz 2000 36 Psycho-educational group for partners of breast cancer patients vs. control Weekly x 90–120 minutes x 6 weeks • No significant effects. • Borderline improvement in mood of partner (p=0.07) and breast cancer patients (p=0.06) 3 months after intervention. (follow-up to 3 months post intervention) Ritz 2000 210 Advanced practice nursing interventions (individual) vs. control Not specified • Intervention led to reduced uncertainty at 1, 3, 6 months (but not at 12 months). • 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 2000 50 Cognitive–behavioral group therapy with muscle relaxation and guided imagery vs. control Weekly x 90 minutes x 6 weeks • Intervention significantly improved mood, vigor and fighting spirit coping at the end of the intervention. • Effects were marginal at 6 months. • No effect on depression or anxiety. (follow-up to 6 months)

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

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

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

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

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

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

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-24 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-25 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-26 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-27 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-28 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-29 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-30 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-31 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-32 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-33 Clinical Trials of Psychosocial Interventions in Breast Cancer

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Meeting Psychosocial Needs of Women with Breast Cancer BOX B-34 Clinical Trials of Psychosocial Interventions in Breast Cancer