A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer

Background: Prostate cancer (PCa) is the most common cancer for men. When treated early enough it is typically curable. However, common treatments, such as radical prostatectomy and radiation therapy, often result in significant negative outcomes with regard to sexual, psychological and social function. Both men and partners have identified the need for more information and support to address sexual health concerns after treatment. However, very few sexual rehabilitation interventions have been developed and rigorously assessed.

Purpose: The investigators propose to develop and pilot test a new program to meet the sexual health needs of men with PCa and their partners using an online, professionally facilitated education/support program. The goals of the program are to improve sexual function, intimacy and mood for men and their partners after treatment for localized PCa. The program will be offered through Cancer Chat Canada, an existing and well-tested Canadian platform for professionally facilitated support group programs.

What Participants Can Expect: A total of 24 men and their female partners (48 individuals) will be recruited and assigned to one of two groups. The first group will participate in the program immediately; the second group will be offered the program after a 5-month delay. The decision about which group will start immediately and which later will be made randomly (by chance). Both groups of men and partners will be asked to complete questionnaires three times and, at the end of the program, to provide the researchers feedback about how satisfied they were with the program, the changes they made, things they learned as a result of the program, and suggestions for improving the program. Participants must have access to a computer, an Internet connection and be willing to attend online, chat room meetings each week for 1.5 hours for 6 weeks.

Implications: Sexual rehabilitation is a high need for men affected by PCa, but is difficult to access. The investigators hope to improve access to sexual health care through this study.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: Couples Prostate Cancer Support Group

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Capital District

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men who have been treated for localized prostate cancer
• AND men must be 6-36 months post-prostatectomy or radiation (as primary treatment) of prostate cancer
• Must have a heterosexual, co-cohabiting partner who is willing to participate
• Must speak and read English
• Must be able to use a computer and have internet access

Exclusion Criteria:

• Homosexual couples will not be included in this study
• Major self-reported psychiatric illness
• Couples who screen below 30 on the DAS (Dyadic Adjustment Scale)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Couples Prostate Cancer Support Group; The participants in the support group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).	Behavioral: Couples Prostate Cancer Support Group; The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions. In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks). In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).
No Intervention: Wait-List Control; Participants will be asked to complete questionnaires at three time points: 1)week 1 2) week 7, and 3) week 13.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Sexual Function from Baseline to 13 weeks	Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks	Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Profile of Mood States Short Form from baseline to 13 weeks	This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.	Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Canada: Beatrice Hunter Cancer Research Institute
• Investigators: Principal Investigator: Deborah L McLeod, R.N., Ph.D., Capital District Health Authority & Dalhousie University; Principal Investigator: Richard J Wassersug, Ph.D., University of British Columbia; Principal Investigator: Karen Fergus, Ph.D., C. Psych., Sunnybrook Odette Cancer Centre & York University; Principal Investigator: John Robinson, Ph.D., C. Psych., Tom Baker Cancer Centre & University of Calgary; Principal Investigator: John Oliffe, R.N, Ph.D., University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2012
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: October 16, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimated): October 30, 2012

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 19, 2024
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Prostate Cancer; Online Intervention; Psychosocial Intervention; Sexual Rehabilitation
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CDHA-RS/2013-076