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

University of British Columbia

Status: Completed

Conditions: Sexual Dysfunction Male; Relationships, Marital; Sexual Dysfunction, Physiological; Prostatic Neoplasms; Prostate Cancer; Sexual Dysfunctions, Psychological

Treatments: Behavioral: Mindfulness-Based Therapy; Behavioral: Cognitive Behavioural Therapy (CBT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03365518

D2017-1893 (Other Grant/Funding Number)

H17-02247

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Currently in a relationship that has lasted longer than 1 year
• Both members of the couple are at least 19 years of age or older
• (At least) one member of the couple has a history of prostate cancer diagnosis
• The same member of the couple underwent treatment (e.g., radical prostatectomy, radiation therapy, Androgen Deprivation Therapy) for their prostate cancer or is on active surveillance
• The member of the couple who underwent treatment for prostate cancer is experiencing distress related to his current level of intimacy/sexual well-being
• Both members of the couple are willing and able to comply with all study procedures and be available for the duration of the study. Commitment includes a total of 5.5 hours per week in sessions and daily homework over the 4-week period of the treatment program for those randomized to receive treatment
• Both members of the couple are fluent in English

Exclusion criteria

• Have a current health condition (e.g., severe cardiovascular health problems, unmanaged diabetes mellitus), physical disability and/or a significant, unmanaged major mental illness (e.g., unmanaged bipolar disorder, psychosis) that would interfere with self- or partnered-sexual activities, or the individual's ability to attend group sessions or complete home assignments

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Cognitive Behavioural Therapy (CBT)

Experimental group

Description:

Treatment will consist of a 4-week group lead by a trained clinician. Sessions are 2 hours in length and take place in consecutive weeks, with daily homework recommended between sessions.

Treatment:

Behavioral: Cognitive Behavioural Therapy (CBT)

Mindfulness-Based Therapy

Experimental group

Description:

Treatment will consist of a 4-week group lead by a trained clinician. Sessions are 2 hours in length and take place in consecutive weeks, with daily homework recommended between sessions.

Treatment:

Behavioral: Mindfulness-Based Therapy

Control - Usual Care

No Intervention group

Description:

Participants who are randomized to the control group will not receive mindfulness or CBT treatment. They will proceed with the course of treatment they were receiving prior to enrollment in the study. As resources for couples dealing with changes to their sexual lives after prostate cancer are limited, it is anticipated that the majority of these patients will have no treatment targeting sexual intimacy during the 6-week period between completing the first and second questionnaire. 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. In this case, they will be issued an additional participant ID within one of the treatment groups.