Know Cancer

or
forgot password

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


Phase 1
N/A
N/A
Open (Enrolling)
Both
Prostate Cancer

Thank you

Trial Information

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


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.


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

EPIC (Expanded Prostate cancer Index Composite)

Outcome Description:

EPIC is a quality of life tool used in prostate cancer studies, focused on physical and sexual outcomes. It is validated with population norms

Outcome Time Frame:

6months

Safety Issue:

No

Principal Investigator

Liz Forbat, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Stirling

Authority:

United Kingdom: Research Ethics Committee

Study ID:

03979

NCT ID:

NCT01842438

Start Date:

October 2012

Completion Date:

August 2015

Related Keywords:

  • Prostate Cancer
  • Sexual Dysfunctions, Psychological
  • Prostatic Neoplasms

Name

Location