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Table 5 Summary of studies

From: Management of sexual dysfunction in breast cancer survivors: a systematic review

Systemic therapy interventions

Reference

Objective

Participantsa

Intervention description

Intervention frequency

Outcome measures

Barton (2007) [34]

To test transdermal testosterone for increasing sexual desire

• Sample size = 150

Two groups:

8-week intervention:

1. Sexual desire (CSFQ desire subscale)

• Mean age 52.3 (SD 7.9)

1. Vanicream + 2 % testosterone (T), then Vanicream (placebo)

• First product: daily x 4 weeks

2. Pleasure (CSFQ pleasure subscale)

• Post-menopause status

• Second product: daily x 4 weeks

3. Sexual function (CSFQ total score)

• History of any cancer (73 % breast cancer)

2. Vanicream (placebo), then Vanicream + 2 % testosterone cream (T)

4. Serum testosterone

5. Serum estradiol

• Decreased sexual desire (Changes of Sexual Functioning Questionnaire, CSFQ)

• Testosterone dose 10.4 mg daily

6. Serum SHBG

7. Serum AST

Buijs (2009) [42]

To test venlafaxine versus clonidine on hot flashes

• Sample size = 60

Two groups:

18-week intervention:

1. Sexual function (Sexual Activity Questionnaire)

• Median age 49-51, range 35-60

1. Clonidine (C) then Venlafaxine (V)

• One medication daily x 8 weeks

• History of breast cancer

2. Venlafaxine, then Clonidine or vice versa

• 2-week washout

• ≥ 14 hot flashes/week

• Second medication daily x 8 weeks

• V: 75 mg once daily

• C: 0.05 mg twice daily

Nunez (2013) [41]

To test bupropion on hot flashes

• Sample size = 55

Two groups:

10-week intervention:

1. Sexual function (Arizona Sexual Experience Scale)

• Median age 49, range 33-71

1. Bupropion (B), then placebo

• One medication daily x 3 days, then twice daily for 25 days

• History of breast cancer

2. Placebo then bupropion

• ≥ 7 hot flashes/week

• B: titrated to 300 mg daily

• 1-week washout

• Second medication daily x 3 days, then twice daily for 25 days

Physical Activity Interventions

Berglund (1994) [45]

To test physical training, information and coping skills training on physical strength, information need and mood symptoms

• Sample size = 199

Two groups:

7-week intervention, 3-months follow up:

1. Sexual problems frequency

• All cancers (80 % breast cancer)

1. Structured rehabilitation run by oncology nurse:

1. Twice-weekly 2-h sessions for first 4 weeks, then one-weekly 2-h session for 3 weeks

• Within 2 months of completing primary cancer treatment

Group sessions on physical training, cancer information, coping training

2. 0 or 1 information session

2. Controls: Cancer information session with oncologist/ dietitian

Duijts (2012) [43]

To test cognitive behavioral therapy and physical exercise on menopausal symptoms

• Sample size = 422

Four groups:

12-week intervention:

1. Sexual function (Sexual Activity Questionnaire, habit subscale)

• Mean age 48.2 (SD 5.6)

1. Cognitive behavioral therapy (CBT): Group sessions on reducing menopausal symptoms

1. 6 weekly groups and 12th week refresher

• ≥ 2 menopausal symptoms over prior 2 weeks

2. Physiotherapist follow up in weeks 4 and 8

2. Physical exercise (PE): Home-based, self-directed exercise program to achieve target heart rates, tailored at start by physiotherapist.

3. CBT/PE

4. Waitlist control

Speck (2010) [44]

To test strength training on perceptions of body image

• Sample size = 295

Two groups:

1-year intervention:

1. Self-perception of appearance and sexuality (Body Image Relationships Scale, appearance and sexuality subscale)

• Mean Age 56.5 (SD 9)

1. Weight-lifting group instruction at community fitness center on warm-up, core exercises, weight-lifting exercises

1. First 13 weeks: twice weekly group sessions

• Lymphedema or at risk for lymphedema

Remaining of year: twice weekly unsupervised exercise; Fitness trainers called participants if they missed sessions.

2. Waitlist control

2. Maintain usual exercise level

Individual-based Counseling and Educational Interventions

Allen (2002) [55]

To test problem-solving therapy for problems and emotional difficulties

• Sample size = 164

Two groups:

16-week intervention:

1. Sexual health (CARES sexual subscale)

• Mean age 42.3 (SD 5.4)

1. Problem-solving therapy: Training sessions and manual on problem solving targeting mid-life breast cancer patients

1. 6 biweekly training sessions with nurse: 2 in person, 4 on telephone

• Initiating chemotherapy

2. Marital relationship (CARES marital subscale)

2. Controls: No therapy

Anderson (2015) [46]

To test a behavioral intervention on menopausal symptoms

• Sample size = 55

Two groups:

12-week intervention:

1. Sexual function (sexual function subscale, Greene Climacteric Scale)

• Mean age 49.2 (SD 6.2)

1. Multi-modal tailored program:

1. Nurse consultation at weeks 1, 6, 12

• < 12 months from primary cancer treatment

Goal setting in consultation with nurse, follow up calls and emails, written health education, newsletters and website

• ≥ 1 menopausal symptom as moderate or severe

2. Controls: Booklet on breast cancer and early menopause

Ganz (2000) [48]

To test behavioral and non-estrogen replacement pharmaco-logic interventions on menopausal symptoms

• Sample size = 76

Two groups:

4-month intervention:

1. Menopausal Symptom Scale Score (hot flash, vaginal and urinary subscales of BCPT Symptom Checklist)

• Mean age 54.5 (SD 5.9)

1. Intervention:

1. Months 0, 2 and 4 visits

2. Sexual health (sexual summary subscale of CARES)

• > 1 menopausal symptom as moderate or severe

Individualized plans of education, counseling, pharmacologic and/or behavioral interventions, psychosocial support, referrals

2. Months 0 and 4 visits

2. Usual care

Germino (2013) [56]

To test an uncertainty management intervention in young survivors

• Sample size = 313

Two groups:

10-month intervention:

1. Sexual function (Medical Outcomes Study – Sexual Functioning)

• Mean age 44

1. Uncertainty management strategies: CD on cognitive and behavioral strategies, written guide booklet on long-term treatment effects, breast cancer resource guide, calls by nurse

1. Weekly 20-min calls x 4

2. Weekly 20-min calls x 4

2. Attention control: Calls by psychology graduate students to talk about cancer experience but no advice offered

Greer (1992) [59]

To test psychological therapy on quality of life

• Sample size = 174

Two groups:

8-week intervention, 4-month follow up:

1. Sexual relationships (subscale of Psychological Adjustment to Illness Scale)

• Mean age 51 (SD 13.6) in therapy group; 52 (SD 11.7) in the control group

1. Psychological therapy: Cognitive behavioral therapy for coping with cancer

1. Weekly sessions x 8

• All cancers except central nervous system and non-melanoma skin cancer (52 % breast cancer)

2. Controls: No therapy

• Psychological morbidity

Jun (2011) [49]

To test a sexual life reframing program on marital intimacy, body image, and sexual function

• Sample size = 60

Two groups:

6-week intervention:

1. Marital intimacy (Martial Intimacy Questionnaire)

• Mean age 45.7 (SD 6.4) in intervention group; 46.2 (SD 6.9) in control group

1. Sexual reframing program: Group sessions of up to 10 women; Sessions on relaxation, perception of problem, exposure, solving problems, acceptance, reframing

1. Weekly 2 h sessions x 6

2. Sexual interest (subscale, CARES)

3. Sexual dysfunction (subscale, CARES)

• Married with male partner

4. Sexual satisfaction (Sexual Satisfaction Scale)

2. Usual care: Offered intervention for 2 h after final data collection

Marcus (2010) [57]

To test a telephone counseling program on psychosocial outcomes

• Sample size = 304

Two groups:

12-month intervention, 18-month follow up:

5. Sexual function, (behavioral, evaluative and body image subscales of Sexual Dysfunction Scale)

• Age < 50: 49 %

1. Telephone Counseling: Booklet with community breast cancer resources; telephone sessions with counselors; Wellness Kit with 6 thematic booklets, 2 progressive relaxation tapes, stress management guide; cognition- and emotion-focused worksheets

• Recent primary cancer treatment completion

1. 45-min telephone sessions: biweekly x 10, then monthly x 6

2. Control: Booklet with community breast cancer resources

Rowland (2009) [51]

To test a psycho-educational group intervention on sexuality and intimacy

• Sample size = 411

Two groups:

6-week intervention:

Likert scales:

• Mean age 57, range 35-86

1. Intervention: Group therapy led by social workers on education, communication training, sensate sex therapy

1. Weekly group sessions x 6

1. Satisfaction with variety of sexual activities

• Distress with sexuality or intimacy, body image, and/or communication with partner

2. Relationship satisfaction

3. Dyspareunia

2. Control: Educational pamphlet on cancer survivorship

4. Pain interferes with pleasure

5. Improved comfort with sexuality

Salonen (2009) [58]

To test a telephone-based social support intervention on quality of life

• Sample size = 250

Two groups:

1-time intervention, 2-week follow-up:

1. Sexual functioning (subscale, EORTC QLQ-BR23)

• Mean age 56-57, range 24-75

1. Telephone support by physiotherapist: education about illness, at-home exercises, counseling on stress-related problems, exploring patient demands and exercises

1. 1-week after breast surgery phone call with therapist (length 3-25 min)

• Newly diagnosed with breast cancer

2. Control: No telephone support

Schover (2006) [52]

To test peer counseling on improving sexual function, knowledge about reproductive health, menopausal symptoms and infertility-related distress

• Sample size = 60

Two groups:

Immediate counseling intervention, 3-month follow up:

1. Sexual Dysfunction (FSFI)

• Mean age 49.2, range 30-77

1. Intervention: In-person peer counselor sessions reviewing Sisters Peer Intervention in Reproductive Issues after Treatment (SPIRIT)

1. 60-90 min peer counseling sessions x 3

• African American

2. Control: Waitlist control with SPIRIT and peer counseling at the end of study

Schover (2011) [53]

To test peer counseling on improving sexual function, knowledge about reproductive health, menopausal symptoms and infertility-related distress

• Sample size = 300

Two groups:

6-week intervention, 6-month, 12-month follow up:

1. Sexual Dysfunction (FSFI)

• Mean age 54.4 (SD 9.7) for peer group; 54.0 (SD 9.8) for telephone group

1. Intervention: In-person peer counselor sessions reviewing Sisters Peer Intervention in Reproductive Issues after Treatment (SPIRIT)

1. 60-90 min peer counseling sessions x 3

• African American

2. 30 min call to counselor encouraged x 1

2. Control: Telephone counseling and SPIRIT workbook

Vos (2004) [60]

To test a group intervention (group psycho-therapy or social support) on psychosocial adjustment

• Sample size = 87

Three groups:

12-week intervention, 3-month follow up:

1. Sexual function (subscale, EORTC QLQ-BR32)

• Mean age 49.2, range 29-68

1. Psychotherapy: Group therapy with cognitive behavior components

1. Weekly 2.5 h sessions x 12; post-treatment 1 and 2 month 2.5 h sessions

• Newly diagnosed with breast cancer

2. Social support: Group therapy with peer support

2. Weekly 2.5 h sessions x 12; post-treatment 1 and 2 month 2.5 h sessions

3. Waitlist control

1 & 2 Group interventions discussed fear of recurrence, coping, body image, sexuality, intimacy, social support.

Couples-based Counseling and Educational Interventions

Baucom (2009) [47]

To test couple-based relationship enhancement on relational distress

• Sample size = 14

Two groups:

12-week intervention, 12-month follow up:

1. Marriage quality (Quality of Marriage Index)

• Median age 50, range 30-80

1. Relationship enhancement intervention: Cognitive behavioral therapy on cancer-related topics

• Married with male partner

1. Biweekly 75 min sessions with therapist x 6

2. Sexual function (Derogatis Inventory of Sexual Functioning)

2. Controls: Community resources list

Christensen (1983) [61]

To test a structured couples treatment program on psychosocial discomfort

• Sample size = 20

Two groups:

6-week intervention:

1. Sexual satisfaction (Sexual Satisfaction Scale)

• Mean age 39.7

1. Therapy sessions on communication and problem solving

1. Weekly sessions x 4

• Married with male partner

• Recent mastectomy

2. Controls: No therapy

Kalaitzi (2007) [50]

To test combined couples and sexual therapies on sexual and body image problems

• Sample size = 40

Two groups:

12-week intervention:

1. Sexual desire frequency

• Mean age 51.8 for intervention group, 53.3 for control group

1. Intervention: Therapy sessions - 1st in hospital; communication training, sensate focus, body imagery, therapist separation

1. Biweekly sessions x 6

2. Intercourse frequency

3. Masturbation frequency

• Married and sexually active with male partner

4. Orgasm frequency

5. Initiative for sex

• Recent simple mastectomy

2. Control: no therapy

6. Satisfaction with relationship

Schover (2013) [54]

To test an Internet-based intervention, with and without sexual counseling, on sexual function and satisfaction

• Sample size = 72

Two groups:

12-week intervention, 6-month follow up:

1. Sexual function (FSFI)

• Mean age 53 (SD 9)

1. Intervention: In-person counseling to review website and behavioral homework (both partners)

1. Counseling sessions x 3

2. Sexual satisfaction (Menopausal Sexual Interest Questionnaire)

• History of breast (80 %) or gynecologic cancer

• Sexually active

2. Self-help controls

• Sexual dysfunction (FSFI score < 26.5)

Both groups: Website on sexual and fertility consequences of cancer, genital anatomy, management of vaginal dryness, communication, dating, treatments for loss of desire, resuming sex comfortably.

• In a partnered relationship

Scott (2004) [96]

To test a couples-based intervention on adjustment to cancer

• Sample size = 94

Three groups:

6-month intervention, 12-month follow up:

1. Sexual self schema (Sexual Self Schema Scale)

• Mean age 51 (SD 9.8)

1. Couple coping training: Booklet, in-person couples counseling on coping and support

• Newly diagnosed breast (61 %) or gynecologic cancer

1. 2-h counseling sessions at baseline, 1-week, 5-weeks, 6 months; telephone calls at 1 and 3 months

2. Sexual desire (subscale, Brief Index of Sexual Function)

• In a partnered relationship

2. Medical information education: Booklet on cancer and brief telephone calls

3. Sexual arousal (subscale, Brief Index of Sexual Function)

2. Telephone calls (<15 min) at baseline, 1- and 2-week post-surgery, 6 and 9 months

3. Patient coping training: Booklet and in-person counseling, telephone calls on coping and support

3. 2-h counseling sessions at baseline, post-surgery, 1-week, 6 months; telephone calls at 1 and 3 months

  1. aAll studies were randomized clinical trials of women with breast cancer (unless otherwise noted)