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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01716702
• Other study ID #: CDHA-RS/2013-076
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2012
• Last updated: March 13, 2014
• Start date: November 2012
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Nova Scotia Health Authority
• Contact: Deborah L McLeod, R.N., Ph.D.
• Phone: 902-473-2964
• Email: DeborahL.McLeod[@]cdha.nshealth.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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).

Locations

Country	Name	City	State
Canada	Capital District	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	Canada: Beatrice Hunter Cancer Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)	No
Primary	Change in Sexual Function from Baseline to 13 weeks		Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)	No
Secondary	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)	No