NCT03365518

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Behavioural Therapy (CBT)	Sessions consist of CBT tools as well as sex therapy techniques and education. The CBT treatment was adapted from the mindfulness-based treatment, but all mentions of mindfulness have been replaced with CBT principles. The therapeutic content presented in this treatment arm is manualized.
BEHAVIORAL	Mindfulness-Based Therapy	The mindfulness-based treatment was developed based on pre-existing mindfulness-based cognitive therapy treatment groups for sexual dysfunction developed by Dr. Lori Brotto at the University of British Columbia Sexual Health Laboratory, mindfulness in Sex therapy and Intimate Relationships (MSIR) treatment group developed by Kocsis and Newbury-Helps (2016), and expert input. Sessions consist of mindfulness-based training as well as sex therapy techniques and education. The therapeutic content presented in this treatment arm is manualized.

Timeline

• Start date: 2017-12-29
• Primary completion: 2020-06-30
• Completion: 2020-11-30
• First posted: 2017-12-07
• Last updated: 2021-04-27

Locations

1 site across 1 country: Canada