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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)