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

NCT03365518 | Completed

• 2 other identifiers: H17-02247D2017-1893
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Change in relationship satisfaction

  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.

  Baseline and Post Treatment (6 weeks)

• Change in relationship satisfaction

  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.

  Baseline and Follow Up (6 months)

• Change in sexual satisfaction/distress

  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.

  Baseline and Post Treatment (6 weeks)

• Change in sexual satisfaction/distress

  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.

  Baseline and Follow Up (6 months)

• Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)

  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.

  Baseline and Post Treatment (6 weeks)

• Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)

  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.

  Baseline and Follow Up (6 months)

• Change in sexual behaviours

  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.

  Baseline and Post Treatment (6 weeks)

• Change in sexual behaviours

  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.

  Baseline and Follow Up (6 months)

Secondary Outcomes (6)

• Change in psychological well-being

  Baseline and Post Treatment (6 weeks)

• Change in psychological well-being

  Baseline and Follow Up (6 months)

• Change in distress

  Baseline and Post Treatment (6 weeks)

• Change in distress

  Baseline and Follow Up (6 months)

• Change in quality of life

  Baseline and Post Treatment (6 weeks)

Other Outcomes (13)

• Change in Mindfulness

  Baseline and Post Treatment (6 weeks)

• Change in Mindfulness

  Baseline and Follow Up (6 months)

• Mindfulness (moderator)

  Baseline

Study Arms (3)

Cognitive Behavioural Therapy (CBT)

EXPERIMENTAL

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.

Behavioral: Cognitive Behavioural Therapy (CBT)

Mindfulness-Based Therapy

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Therapy

Control - Usual Care

NO INTERVENTION

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.

Interventions

Cognitive Behavioural Therapy (CBT) BEHAVIORAL

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.

Cognitive Behavioural Therapy (CBT)

Mindfulness-Based Therapy BEHAVIORAL

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.

Mindfulness-Based Therapy

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Prostate Centre: collaborator

Study Sites (1)

Gordon & Leslie Diamond Health Centre -- Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Links

• Vancouver Prostate Centre Website
• University of British Columbia Sexual Health Lab Website

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lori Brotto, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 7, 2017
• Study Start: December 29, 2017
• Primary Completion: June 30, 2020
• Study Completion: November 30, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)