Innovations in the Treatment of Sexual Health Post Prostate Cancer Treatment: Comparing Mindfulness vs. CBT — INTROSPPECT  

Prostate Cancer Clinical Trial

Official title: Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer: A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy

Status Completed

Clinical Trial Summary

Up to 90% of men experience sexual difficulties after receiving treatment for prostate cancer (PC), which can negatively affect their intimate relationships and overall quality of life. In this randomized clinical trial, the investigators will assess and compare two evidence-based treatments, mindfulness-based therapy and cognitive behavioral therapy (CBT), for couples with sexual complaints following PC treatment to controls who will receive no intervention.

Clinical Trial Description

This randomized clinical trial is designed to assess and compare efficacy of two treatment manuals for couples with sexual difficulties secondary to PC treatment: mindfulness-based therapy and CBT. A third arm, where couples receive no intervention will act as a control group. Those randomized to the "control" group will have the opportunity to be randomized to one of the treatment groups following their third and final questionnaire if they wish.

Men and their partners will be invited to participate through the Vancouver Prostate Centre's Prostate Cancer Supportive Care Program (PCSC) at Vancouver General Hospital.

Eligible couples will be randomized to either: 4 consecutive weeks of mindfulness-based therapy, CBT, or no intervention (4-6 couples in each treatment group at a time). All participants will complete an online questionnaire package to assess primary, secondary, and tertiary outcomes at the time of study enrollment or baseline (Time 1). All participants will be invited to complete a Time 2 questionnaire once approximately 6 weeks after they complete the Time 1 questionnaire (for couples randomized to the treatment arms, this will be immediately post-treatment). Finally, all participants will be invited to complete the Time 3 follow up questionnaire 6 months after they complete the Time 2 (post-treatment) questionnaire.

Endpoints will assess effects on intimacy and overall Quality of Life. Additional endpoints of other factors affecting improvement (i.e., moderators like personality and treatment adherence) will be assessed. The investigators predict improvements in both mindfulness-based and cognitive behavioural therapy treatments; moderators will provide insights into which participants benefit most from each treatment arm.

Moreover, in order to improve understanding of the lived experience of patients who take part in the treatment groups or control arm, this study will invite all participants to take part in an exit interview after their Time 2 (post-treatment) questionnaire is completed. A research team member who was not a treatment facilitator will conduct the exit interviews. This information will then be transcribed and used for qualitative data analyses. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Relationships, Marital
• Sexual Dysfunction Male
• Sexual Dysfunction, Physiological
• Sexual Dysfunctions, Psychological

• NCT number: NCT03365518
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: N/A
• Start date: December 29, 2017
• Completion date: November 30, 2020