NCT01842438

A Couple Support Intervention for Prostate Cancer

Psychosexual Support Following Prostate Cancer Surgery: Feasibility and Outcomes of a Couple-based Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: University of Stirling · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Even with careful prostate surgery, men find it difficult to have an erection. Our previous research shows that couples are not often supported to cope with the effects of surgery on their sexual relationships. In this study, the investigators will design a way of supporting couples, and test how well it works. The investigators will decide what the support should include (e.g. duration, frequency and timing of the support). The investigators will do this by looking at available literature on the subject. The investigators will recruit 68 couples to the study, half will receive standard care and the other half will be invited to attend six sessions of psychosexual support with specially trained professionals (trained by men affected by prostate conditions and a cancer/couple support specialist). Before and after the support, men and their partners will be asked to complete questionnaires which measure quality-of-life, emotional needs, and their relationship. The investigators will ask the couples to fill out the questionnaires again six-months later to see if the support has long-term benefits. At the end of the study the investigators will also interview 10 couples to find out their views of the support, and another 10 couples about standard treatment. When the investigators have tested this support, they expect to see men and their partners tell us that their quality of life has improved, and they have higher satisfaction with their relationship. The investigators will calculate the overall cost of providing this support, and the benefits it has on reducing the need for other health-care services (like General Practice use).

Detailed description

Scientific abstract Evidence shows significant unmet psychosexual needs for couples affected by prostate cancer. Studies have identified the contribution that psychosocial interventions could have for couples, e.g. strengthening healthy adaptation and better communication, developing coping skills for distressed couples, and facilitating healthy spousal communication to address the sexual rehabilitation needs. This is a feasibility study with a built-in pilot, which will examine the acceptability, feasibility and outcomes of a psychosexual intervention to support couples, drawing on the Medical Research Council complex intervention framework. The intervention will be developed from the extant and our pilot work. Men in outpatient surgical follow-up clinics will be screened using EPIC, and recruited if scoring under the clinical threshold for potency. 68 couples will be randomised to two arms, one receiving six sessions of couple-support from specially trained counsellors and the others receiving standard care. The primary outcome measure is health-related quality-of-life. Pre, post and 6-month follow-up outcomes will be measured in both individual (quality of life; anxiety/depression) and in relational terms (relationship between couples). An economic analysis will identify population costs.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral: psychosexual intervention	6 session manualised intervention, This manual-based family-relational-psychosexual support was based on systemic principles combined with techniques from sex therapy, i.e. sensate focus. The manual offered an intermediate level of specificity, enabling practitioners to use their own therapeutic style and take some lead from the couple while meeting the objectives of the intervention. Specialist training in delivery of the intervention was provided to practitioners holding accredited counselling or psychotherapy qualifications. Practitioners engaged in routine clinical supervision with one additional team supervision session offered by one of the practitioners

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-07-01
• Completion: 2015-08-01
• First posted: 2013-04-29
• Last updated: 2017-06-05
• Results posted: 2016-06-22

Locations

1 site across 1 country: United Kingdom