Clinical trial NCT03177707: Intimacy and Mindfulness Post-Prostate Cancer Treatment
Official title: Mindfulness-based Therapy Group Intervention for Couple's Dealing With Sexual Dysfunction After Prostate-cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Sexual Dysfunction
Lead sponsor: Vancouver Prostate Centre
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Couples will be randomized to an immediate or delayed treatment group; the delayed treatment couples will be considered the waitlist control group in this study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: With improvements in detection and treatment of prostate cancer (PCa), more men than ever are living with side effects from PCa treatment; most distressingly, treatment side effects include problems with sexual functioning (e.g. erectile dysfunction, climacturia, inorgasmia). This study aims to develop a mindfulness-based group treatment for couples with sexual functioning complaints post-PCa treatment. Couples will be invited to a four-session mindfulness-based treatment group. Pre- and post-treatment outcomes (e.g., distress, sexual functioning/enjoyment, relationship satisfaction, treatment adherence) will assess feasibility and effectiveness of this novel treatment for couple's sexual lives after PCa.

Detailed description: This is an intervention study designed to assess a novel mindfulness-based treatment protocol for couples dealing with sexual dysfunction secondary to prostate cancer treatment. Couples will be invited to participate through the Vancouver Prostate Centre (VPC) and the Prostate Cancer Survivorship Care (PCSC) Program. Interested couples will be screened for eligibility. Eligible couples will be randomized to either an immediate-start or a delayed-waitlist control group.

Prior to treatment, couples will complete an online questionnaire package. Treatment will consist of a 4-week mindfulness-based group lead by a clinician trained in mindfulness treatment. Sessions are 2hrs in length and take place in consecutive weeks, with daily homework recommended between sessions. The intervention was developed based on pre-existing mindfulness-based cognitive therapy treatment groups for sexual dysfunction developed by Dr. Lori Brotto at the UBC 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, sex therapy techniques, and education. After treatment, couples will be invited to complete a post-treatment questionnaire once immediately after the end of treatment, and again 6 months later.

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
* Both members of the couple are able to speak and read English (to date, all of the treatment material is delivered in English)
* (At least) one member of the couple has a history of prostate cancer diagnosis
* The same member of the couple underwent radical prostatectomy for the treatment of his prostate cancer
* Both members of the couple are willing and able to comply with all study procedures (including committing to daily homework over the 4-week period of the treatment program) and be available for the duration of the study
* Both members of the couple provide signed and dated informed consent form

Exclusion Criteria:

* The individual who was treated with prostate cancer received androgen deprivation therapy or radiation therapy to treat their prostate cancer.
* Have a current health condition (e.g., severe cardiovascular health problems, unmanaged diabetes mellitus), physical disabilities, or mental health issues (e.g., severe anxiety, depression) 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: Sexual correlates: Self-reported sexual functioning
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Sexual correlates: Self-reported erectile functioning
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: Sexual correlates: GMSEX
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Sexual correlates: GMSEX
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: Sexual correlates: Sexual activity scale
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Sexual correlates: Sexual activity scale
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: Sexual correlates: Adapted dyadic adjustment scale
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Sexual correlates: Adapted dyadic adjustment scale
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
Secondary outcomes:
measure: mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: mental and health-related quality of life indices: UCLA Prostate Cancer Index
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: mental and health-related quality of life indices: UCLA Prostate Cancer Index
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
Other outcomes:
measure: Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: Treatment mechanisms factors: Expectations for treatment
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Treatment mechanisms factors: Expectations for treatment,
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: Treatment mechanisms factors: Time since prostate cancer treatment
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Treatment mechanisms factors: Time since prostate cancer treatment
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: Treatment mechanisms factors: Penile Rehabilitation Aids Use
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Treatment mechanisms factors: Penile Rehabilitation Aids Use
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
measure: Treatment mechanisms factors: Mindfulness Practice
timeFrame: Change from baseline to post-intervention (5 weeks)
measure: Treatment mechanisms factors: Mindfulness Practice
timeFrame: Change from post-intervention (5 weeks) to 6-month follow up
Locations:
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: