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

Not Applicable

Completed

• Conditions: Prostate Cancer; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Sexual Dysfunction Male; Relationships, Marital; Prostatic Neoplasms
• Interventions: Behavioral: Cognitive Behavioural Therapy (CBT); Behavioral: Mindfulness-Based Therapy

• Registration Number: NCT03365518
• Lead Sponsor: University of British Columbia

Brief 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.

Study Timeline

• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Study Start: 2017-12-29
• Primary Completion: 2020-06-30
• Study Completion: 2020-11-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioural Therapy (CBT)	Cognitive Behavioural Therapy (CBT)	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.
Mindfulness-Based Therapy	Mindfulness-Based Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in relationship satisfaction	Baseline and Follow Up (6 months)	Adapted dyadic adjustment scale (A-DAS). The A-DAS is a validated, 7-item measure that assesses relationship adjustment. Total scores range from 0-36 with higher scores indicating greater dyadic adjustment.
Change in sexual behaviours	Baseline and Follow Up (6 months)	Sexual activity scale. This is a questionnaire developed by the study lead that asks individuals to indicate whether they engaged in a range of sexual activities over 3 time-periods: (a) ever, (b) since their/their partner's prostate cancer surgery, and (c) in the past 4 weeks. There are 15 items on this scale which can be indicated over the three time periods mentioned previously. By tallying the categorical answers (yes or no), total scores can range from 0 to 45 with higher scores indicating greater sexual activity engaged. Subset scores at each time point range from 0-15 and indicate sexual activity in the same way as the total score.
Change in sexual satisfaction/distress	Baseline and Follow Up (6 months)	Female sexual distress scale - revised (FSDS-R). The FSDS-R is a 13-item measure that assesses sexual distress. Although named for its use with women, this measure has been validated as a measure of sexual distress in women and men. Each item is rated on a scale of 0-4. The total score is a summation, ranging from 0 to 52, and provides a measure of sexual distress in which higher scores represent higher levels of sexual distress.
Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)	Baseline and Follow Up (6 months)	International Index of Erectile Functioning (IIEF) is a 15-item self-reported scale of men's sexual functioning. The scale has five domains: Erectile Function, Intercourse Satisfaction; Orgasmic Function, Overall Satisfaction, and Sexual Desire with ranges 1-30, 0-15, 0-10, 2-10, and 2-10 respectively. Total scores (sum) range from 5-75. Lower domain and total scores denote lower sexual function.; OR International Index of Erectile Functioning for Men who have sex with men (IIEF-MSM) is a 22-item measure of sexual function. Total scores (sum) range from 0-95; lower scores indicate lower sexual function.; OR Female Sexual Functioning Index (FSFI) is a 19-item measure of self-reported sexual dysfunction in women. The scale includes six domains with the following ranges: 1.2-6 for desire; 0-6 for arousal, lubrication, orgasm, and pain; and 0.8-6 satisfaction. Total scores (sum) range from 2 to 36. Lower domain and total scores indicate lower sexual functioning.

Secondary Outcome Measures

Name	Time	Method
Change in psychological well-being	Baseline and Follow Up (6 months)	Hospital Anxiety and Depression Scale (HADS). The HADS is a validated, 14-item measure of depression and anxiety. Total scores range from 0-42, composed of the sum of two sub-scales for anxiety and depression both ranging from 0-21. Higher scores indicate higher levels of anxiety and/or depression symptoms.
Change in distress	Baseline and Follow Up (6 months)	Distress Thermometer. The distress thermometer is a single-item distress screening scale, which has been shown to be a valid measure of cancer-specific distress among prostate cancer patients and their partners. Participants indicate their current level of distress on an 11-point scale from 0-10 with 0 being no distress and 10 being extreme distress.
Change in quality of life	Baseline and Follow Up (6 months)	World Health Organization Quality of Life - Brief Form (WHOQOL-BREF). This is a 26-item measure that assesses overall quality of life in four domains of physical health, psychological well-being, social relationships, and environmental well-being. The four domains score with a range from 4-20 with higher scores representing higher quality of life in each domain.

Trial Locations

Locations (1)

Gordon & Leslie Diamond Health Centre -- Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada