A Couple Support Intervention for Prostate Cancer

• ClinicalTrials.gov Identifier: NCT01842438
• Recruitment Status: Completed
• First Posted: April 29, 2013
• Results First Posted: June 22, 2016
• Last Update Posted: June 5, 2017
• Sponsor: University of Stirling
• Collaborator: Prostate Cancer UK
• Information provided by (Responsible Party): Prof Liz Forbat, University of Stirling

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Behavioral: Behavioral: psychosexual intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Psychosexual Support Following Prostate Cancer Surgery: Feasibility and Outcomes of a Couple-based Intervention
• Study Start Date: October 2012
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Behavioral: psychosexual intervention; 6-sessions of couple support focused on relationships and psychosexual functioning	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
No Intervention: Control; This group will not receive the intervention during the life-span of the project

Outcome Measures

Primary Outcome Measures :

1. EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale [ Time Frame: 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 :

1. HADS (Hospital Anxiety and Depression Scale) [ Time Frame: 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.

2. SCORE15 (Systemic Core Outcome Measure) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United Kingdom

Western General Hospital

Edinburgh, Lothian, United Kingdom, EH4 2XU

Sponsors and Collaborators

University of Stirling

Prostate Cancer UK

Investigators

• Principal Investigator: Liz Forbat, PhD; University of Stirling

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Prof Liz Forbat, Reader, University of Stirling
• ClinicalTrials.gov Identifier: NCT01842438
• Other Study ID Numbers: 03979
• First Posted: April 29, 2013
• Results First Posted: June 22, 2016
• Last Update Posted: June 5, 2017
• Last Verified: May 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Consent was not gained for data sharing in this manner

Keywords provided by Prof Liz Forbat, University of Stirling:

Sexual Dysfunctions, Psychological

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases