A Couple Support Intervention for Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01842438
• Other study ID #: 03979
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 24, 2013
• Last updated: December 2, 2014
• Start date: October 2012
• Est. completion date: August 2015

Study information

• Verified date: December 2014
• Source: University of Stirling
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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 GP use).

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 MRC 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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 136
• Est. completion date: August 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Score of =60 on EPIC (a signal of potency)

• >11 weeks post-operative for 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Behavioral: psychosexual intervention

Locations

Country	Name	City	State
United Kingdom	Western General Hospital	Edinburgh	Lothian

Sponsors (2)

Lead Sponsor	Collaborator
University of Stirling	Prostate Cancer UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EPIC (Expanded Prostate cancer Index Composite)	EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms	6months	No
Secondary	HADS (Hospital Anxiety and Depression Scale)	the HADS has two scales: one anxiety and one depression. It is validated with population norms	6months	No
Secondary	SCORE15 (systemic core outcome measure)	SCORE15 is an index of Family Function and Change, with 15 items.	6months	No