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

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.

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).

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.

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.

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.

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.

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.

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.

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.

Kolcaba

1999

53

Guided imagery audiotape vs. control

Audiotape use daily during radiation and for 3 weeks after

• Intervention significantly improved comfort.

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).

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.

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).

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.

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.

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.

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.”

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).

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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

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

Spiegel

1981

1983

1989

Metastatic

86

• Supportive–expressive group therapy with relaxation

≥ 1 year

• Improved mood, reduced maladaptive coping responses and phobias.

• Prolonged survival.

12 months

12 months

Classen

2001

Metastatic

125

• Supportive–expressive group therapy with relaxation

Indefinite

• Reduced traumatic stress symptoms

• Enhanced mood if final measurement during the year prior to death excluded

12 months

12 months

Goodwin

2002

Metastatic

235

• Supportive–expressive group therapy with relaxation

Indefinite

• Improved mood, reduced experience of pain

12 months

12 months

Fukui

2000

Early

50

• Cognitive–behavioral group with relaxation and guided imagery

6 weeks

• Improved mood, vigor, fighting spirit

8 weeks

6 months**

Antoni

2001

Early

100

• Structured cognitive–behavioral group

10 weeks

• No overall effects

• Reduced prevalence of moderate depression, increased benefit finding/optimism

_______

9 months

Edelman

1999

Metastatic

121

• Cognitive–behavioral group

5 months

• Improved mood, reduced depression, enhanced self-esteem

5 months

11 months

Edmonds

1999

Cunningham

1999

Metastatic

66

• Supportive plus cognitive–behavioral

35 weeks

• Increased anxious-preoccupied coping, reduced helplessness, coping “Little psychometric effects”

12 months

12 months

Cimprich

1988

Early

32

• Individualized intervention to restore attentional capacity

? (short-term)

• Enhanced attentional capacity

90 days

90 days

Burton

1995

Early

200

• Psychological interview

• Psychological interview plus psychotherapy

• Psychological interview plus chat

1 day

• Psychological interview led to lasting reduction in body image distress, overall distress, anxiety, depression, enhanced fighting spirit.

• Psychotherapy beneficial among women with stressful life events.

1 year

1 year

Maunsell

1996

Early

259

• Telephone screening for distress

12 months

• No effects.

_______

1 year

Marchioro

1996

Early

36

• Cognitive–behavioral counseling

? (short-term)

• Improved depression and quality of life.

9 months

9 months

Maguire

1980

1983

Early

172

• Nurse specialist counseling

“Until woman had adapted well”

• Increased recognition of need for psychiatric referral.

• Psychiatric intervention reduced morbidity.

12 to 18 months

12 to 18 months

McArdle

1996

Early

272

• Nurse specialist support

• Voluntary organization support

• Both

• Neither

?

• Nurse specialist led to improved somatic symptoms, social dysfunction and depression.

12 months

12 months

Wengström

1999

2000

2001

Early

134

• Nursing intervention based on Orem’s model for self-care

5 weeks

• Fewer distress reactions, stronger motivation to be emotionally involved.

3 months

3 months

Sandgren

2000

Early

62

• Telephone-based cognitive–behavioral therapy

16 weeks

• No consistent effects.

• Borderline effects on stress, anxiety, confusion, physical role functioning and mental health varied over time.

10 months

10 months

Ritz

2000

Early

210

• Advanced practice nursing interventions

?

• Reduced uncertainty (especially in unmarried women).

• Beneficial early effect on mood in those without a family history.

3 to 6 months

12 months

Lev

2001

Early

53

• Nurse counseling plus videotape plus self-care booklet

5 months

• No significance testing “Small to large effect sizes for HRQOL, psychiatric symptoms”.

8 months

8 months

Allan

2002

Early

164

• Problem-solving skills training

(2 session in person, 4 by telephone)

4 months

• No overall effects.

• Subgroup analysis suggested benefit in women with good problem-solving skills.

8 months

8 months