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 Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
- Change in Sexual Function from Baseline to 13 weeks [ Time Frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13) ] [ Designated as safety issue: No ]
- Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks [ Time Frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13) ] [ Designated as safety issue: No ]
- Change in Profile of Mood States Short Form from baseline to 13 weeks [ Time Frame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13) ] [ Designated as safety issue: No ]This tool assesses psychological distress across 6 domains: fatigue-inertia, vigor-activity, tension-anxiety, depression-dejection, anger-hostility, and confusion-bewilderment.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
|Experimental: Couples Prostate Cancer Support Group||Behavioral: Couples Prostate Cancer Support Group|
|No Intervention: Wait-List Control|
|Contact: Deborah L McLeod, RN, PhD.||902-473-2964||DeborahL.McLeod@cdha.nshealth.ca|
|Canada, Nova Scotia|
|Capital District||Not yet recruiting|
|Halifax, Nova Scotia, Canada|
|Contact: Deborah L McLeod 902-473-2964 DeborahL.McLeod@cdha.nshealth.ca|
|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|