Clinical trial NCT01842438: A Couple Support Intervention for Prostate Cancer
Official title: Psychosexual Support Following Prostate Cancer Surgery: Feasibility and Outcomes of a Couple-based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Sexual Dysfunctions, Psychological
Lead sponsor: University of Stirling
Sponsor class: OTHER
Collaborators: name: Prostate Cancer UK
First posted: 2013-04-29
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Score of ≤60 on EPIC (a signal of potency) (EPIC is the Expanded Prostate Cancer Index Composite)
* \>11 weeks post-operative for Prostate Cancer (PCa) (to recruit people who have recovered from the immediate effects from surgery and begun to regain some functioning. Follow-ups are held at 6weeks, 12weeks, 6months from surgery, until no further follow-up is required).
* Has a partner

Exclusion Criteria:

* Does not have a partner (this is a couple intervention, the study can therefore only include men with a partner).
* Prognosis of ≤1year (Most men who have had recent surgery will have a good prognosis, consequently it is unlikely that many men will be excluded by this criteria.)
* Unable to provide informed consent.
* Residing in Dumfries and Galloway. The recruiting clinic sees patients from a wide catchment area. However to prevent excess burden on participants traveling to the intervention site in Edinburgh, the investigators will exclude those living in Dumfries and Galloway.
* \>2 years from surgery (since long term adaptation will have commenced).
* Unable to communicate in English (this is a feasibility trial, if the study moves to a full scale trial in future then it will seek to include couples and interpreters/translators).

Primary outcomes:
measure: EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale
timeFrame: Basline (T0), immediate post-intervention (T1) and 6 Months (T2)
Secondary outcomes:
measure: HADS (Hospital Anxiety and Depression Scale)
timeFrame: Basline (T0), immediate post-intervention (T1) and 6 Months (T2)
measure: SCORE15 (Systemic Core Outcome Measure)
timeFrame: Basline (T0), immediate post-intervention (T1) and 6 Months (T2)
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
state: Lothian
Study officials:
affiliation: University of Stirling
name: Liz Forbat, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robertson JM, Molloy GJ, Bollina PR, Kelly DM, McNeill SA, Forbat L. Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial. Trials. 2014 May 24;15:183. doi: 10.1186/1745-6215-15-183.