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. 2020 Jun 2;2020(6):CD007568. doi: 10.1002/14651858.CD007568.pub2

Reese 2018.

Study characteristics
Methods Setting: USA
Recruitment: breast cancer survivors were identified through providers’ schedules and the institutional tumour registry. Women were eligible if they (a) were age ≥ 21years, (b) were in a stable relationship (i.e. living with a romantic partner for ≥ 6 months) that could involve sexual activity, (c) had completed active treatment 6 months to 5 years ago for non‐recurrent stage I–III breast cancer (current use of endocrine therapy was acceptable), and (d) scored ≥ 3 on the Patient Care Monitor sexual concerns screening item. Women were excluded if they had a past history of any cancer other than non‐melanoma skin cancer, an ECOG performance score > 2 (or were judged as being too ill to participate), or overt cognitive dysfunction or psychiatric disturbance; were pregnant; or were currently engaged in couple or marital therapy; or if either they or their partner had hearing impairment or were not able to speak English. No exclusions were made based on sexual orientation
Randomisation: 2‐arm RCT
Participants 29 women with breast cancer and their partners (20 IE, 9 LHT)
Interventions Both arms consisted of four 60 to 75 minute weekly sessions delivered by telephone to both members of the couple by the interventionist and included session handouts for both survivors and partners sent in advance of the scheduled session
Intimacy Enhancement (IE) arm: 4 sessions of education and skills training to address survivors’ sexual concerns and to improve intimacy. Techniques include sensual touching exercises adapted to incorporate specific instructions for how to deal with thoughts and feelings about breast touching during these exercises, communication skills with regard to sex and intimacy, identifying and challenging overly negative or inflexible sexually related cognitions, and broadening the repertoire of both sexual and non‐sexual intimacy building activities. Each of the 4 sessions includes a detailed agenda and topic, 1 or more skills practice sessions, and assignment of home practice exercises
Living Healthy Together (LHT) arm: education and support across a range of topics: education on finding support and the breast cancer experience, what it means to “live healthy together” (session 1), stress and stress management (session 2), fatigue and sleep (session 3), and diet and nutrition (session 4). Each session consisted of interactive discussion and activities including self‐assessment and discussions both with the interventionist and between members of the couple in relation to the session topic
Interventionist: trained health care professionals (social work or counselling/psychology)
Outcomes
  • Satisfaction with therapeutic services

  • Programme evaluation

  • Sexual function

  • Sexual satisfaction

  • Survivors’ sexual distress

  • Self‐efficacy for coping with sexual concerns

  • Perceived quality of communication about sex

  • Emotional intimacy

  • Relationship quality

  • Cancer‐related distress

  • Survivors’ body image distress

  • Survivors’ psychological distress


Method of assessing outcome measures:
  • Client Satisfaction Questionnaire (CSQ‐8)

  • Brief programme evaluation survey

  • Female Sexual Function Index (FSFI)

  • International Index of Erectile Functioning (IIEF)

  • PROMIS SexFS version 2 Global Sexual Satisfaction Scale

  • Female Sexual Distress Scale ‐ Revised (FSDS‐R)

  • 3‐item survey of self‐efficacy for coping with sexual concerns

  • Dyadic Sexual Communication Scale (DSCS)

  • Emotional Intimacy subscale of the Personal Assessment of Intimacy in Relationships (PAIR)

  • Dyadic Adjustment Scale (DAS‐7)

  • Impact of Event Scale ‐ Revised Body Image Scale (BIS) Patient Health Questionnaire (PHQ‐9) 7‐item measure of Generalized Anxiety Disorder (GAD‐7)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Study biostatistician generated the randomisation sequence (2:1 ratio)
Allocation concealment (selection bias) High risk Project manager assigned participants to interventions
Blinding (performance bias and detection bias)
All outcomes Unclear risk No details
Incomplete outcome data (attrition bias)
All outcomes Low risk Study retention 97%
Selective reporting (reporting bias) Low risk Balanced reporting for all measures
Other bias Low risk The trial appears to be free of other problems that could put it at high risk of bias