A Couple Support Intervention for Prostate Cancer

NCT01842438 | Completed Results DMC

• 1 other identifier: 03979
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Sexual Dysfunctions, Psychological

Outcome Measures

Primary Outcomes (1)

• EPIC (Expanded Prostate Cancer Index Composite), Sexual Bother Subscale

  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.

  Basline (T0), immediate post-intervention (T1) and 6 Months (T2)

Secondary Outcomes (2)

• HADS (Hospital Anxiety and Depression Scale)

  Basline (T0), immediate post-intervention (T1) and 6 Months (T2)

• SCORE15 (Systemic Core Outcome Measure)

  Basline (T0), immediate post-intervention (T1) and 6 Months (T2)

Study Arms (2)

Behavioral: psychosexual intervention

EXPERIMENTAL

6-sessions of couple support focused on relationships and psychosexual functioning

Behavioral: Behavioral: psychosexual intervention

Control

NO INTERVENTION

This group will not receive the intervention during the life-span of the project

Interventions

Behavioral: psychosexual intervention BEHAVIORAL

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

Behavioral: psychosexual intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Stirling: lead
• Prostate Cancer UK: collaborator

Study Sites (1)

Western General Hospital

Edinburgh, Lothian, EH4 2XU, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24886676 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Under-recruitment means the study is not powered (though the study was designed as a pilot, so not hypothesis testing).

Results Point of Contact

• Title: Prof Liz Forbat, PI
• Organization: Australian Catholic University

elizabeth.forbat@acu.edu.au

+61 475978476

Study Officials

• Liz Forbat, PhD

  University of Stirling

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader

Study Record Dates

• First Submitted: April 24, 2013
• First Posted: April 29, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: June 5, 2017
• Results First Posted: June 22, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)