Prostate Cancer Clinical Trial
Official title:
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.
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) |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Canada | Capital District | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority | Canada: Beatrice Hunter Cancer Research Institute |
Canada,
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 |
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