A Couple Support Intervention for Prostate Cancer

Not Applicable

Completed

Conditions: Prostate Cancer

Registration Number: NCT01842438

Lead Sponsor: University of Stirling

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 86

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale	Basline (T0), immediate post-intervention (T1) and 6 Months (T2)	EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms. We used the sexual bother sub-scale as the primary outcome measure; score range 0-400. A higher score indicates better function/better outcome.

Secondary Outcome Measures

Name	Time	Method
HADS (Hospital Anxiety and Depression Scale)	Basline (T0), immediate post-intervention (T1) and 6 Months (T2)	The HADS has two scales: one anxiety and one depression. It is validated with population norms. Results are presented for T2 (6 month follow-up) and split by Patient, Partner and again by Intervention, Control. Responses are scored on a scale of 0-3 (3 indicates higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.
SCORE15 (Systemic Core Outcome Measure)	Basline (T0), immediate post-intervention (T1) and 6 Months (T2)	SCORE15 is an index of Family Function and Change, with 15 items. The potential range of scores is 15 to 75, with a lower score indicating higher family functioning. Total scores are reported in the data below.