Clinical trial NCT01716702: A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer
Official title: A Feasibility Study of an Online Intervention for Sexual Rehabilitation in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Psychosocial Intervention
Sexual Rehabilitation
Online Intervention
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Sexual Function from Baseline to 13 weeks
timeFrame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
Secondary outcomes:
measure: Change in Personal Assessment of Intimacy and Relationships from baseline to 13 weeks
timeFrame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
Other outcomes:
measure: Change in Profile of Mood States Short Form from baseline to 13 weeks
timeFrame: Pre-Intervention (Week 1); Post-Intervention (Week 7); 3 Months Post-Intervention (Week 13)
Locations:
city: Halifax
country: Canada
facility: Capital District
state: Nova Scotia
Study officials:
affiliation: Capital District Health Authority & Dalhousie University
name: Deborah L McLeod, R.N., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Richard J Wassersug, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Odette Cancer Centre & York University
name: Karen Fergus, Ph.D., C. Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tom Baker Cancer Centre & University of Calgary
name: John Robinson, Ph.D., C. Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: John Oliffe, R.N, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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