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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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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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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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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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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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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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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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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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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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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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BOX B-26
Clinical Trials of Psychosocial Interventions in Breast Cancer
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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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BOX B-30
Clinical Trials of Psychosocial Interventions in Breast Cancer
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BOX B-31
Clinical Trials of Psychosocial Interventions in Breast Cancer
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BOX B-32
Clinical Trials of Psychosocial Interventions in Breast Cancer
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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
Representative terms from entire chapter:
psychosocial interventions
