Clinical trial NCT03365518: Innovations in the Treatment of Sexual Health Post Prostate Cancer Treatment: Comparing Mindfulness vs. CBT
Official title: Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer: A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Sexual Dysfunction Male
Relationships, Marital
Prostatic Neoplasms
Keywords: Psychological Treatment
Intimacy
Cognitive Behavioural Therapy
Cognitive Behavioral Therapy
Mindfulness
Group Therapy
Couples Therapy
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Vancouver Prostate Centre
First posted: 2017-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in relationship satisfaction
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in relationship satisfaction
timeFrame: Baseline and Follow Up (6 months)
measure: Change in sexual satisfaction/distress
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in sexual satisfaction/distress
timeFrame: Baseline and Follow Up (6 months)
measure: Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)
timeFrame: Baseline and Follow Up (6 months)
measure: Change in sexual behaviours
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in sexual behaviours
timeFrame: Baseline and Follow Up (6 months)
Secondary outcomes:
measure: Change in psychological well-being
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in psychological well-being
timeFrame: Baseline and Follow Up (6 months)
measure: Change in distress
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in distress
timeFrame: Baseline and Follow Up (6 months)
measure: Change in quality of life
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in quality of life
timeFrame: Baseline and Follow Up (6 months)
Other outcomes:
measure: Change in Mindfulness
timeFrame: Baseline and Post Treatment (6 weeks)
measure: Change in Mindfulness
timeFrame: Baseline and Follow Up (6 months)
measure: Mindfulness (moderator)
timeFrame: Baseline
measure: Mindfulness (moderator)
timeFrame: Post-Treatment (Week 6)
measure: Mindfulness (moderator)
timeFrame: Follow-Up (6 Months)
measure: Expectations for treatment (moderator)
timeFrame: Baseline for Treatment Groups
measure: Expectations for treatment (moderator)
timeFrame: Post-Treatment (Week 6)
measure: Expectations for treatment (moderator)
timeFrame: Follow-Up (6 Months) for Treatment Groups
measure: Therapeutic Skills Practice (moderator)
timeFrame: Week 1-4 for Treatment Groups
measure: Therapeutic Skills Practice (moderator)
timeFrame: Follow-Up (6 Months) for Treatment Groups
measure: Big Five Inventory-10 (moderator)
timeFrame: Baseline
measure: Pre-treatment sexual functioning (moderator)
timeFrame: Baseline
measure: Time elapsed since treatment (moderator)
timeFrame: Baseline and Follow-Up (6 Months)
Locations:
city: Vancouver
country: Canada
facility: Gordon & Leslie Diamond Health Centre -- Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: