Intimacy and Mindfulness Post-Prostate Cancer Treatment

NCT03177707 | Completed

• 1 other identifier: IMPPACT
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Sexual Dysfunction

Outcome Measures

Primary Outcomes (8)

• Sexual correlates: Self-reported sexual functioning

  Depending on sexual orientation and gender, individuals will complete either (1) International Index of Erectile Functioning (heterosexual men), International Index of Erectile Functioning for Men who have sex with men (gay men), or Female Sexual Functioning Index (female partners)

  Change from baseline to post-intervention (5 weeks)

• Sexual correlates: Self-reported erectile functioning

  Depending on sexual orientation and gender, individuals will complete either (1) International Index of Erectile Functioning (heterosexual men), International Index of Erectile Functioning for Men who have sex with men (gay men), or Female Sexual Functioning Index (female partners)

  Change from post-intervention (5 weeks) to 6-month follow up

• Sexual correlates: GMSEX

  GMSEX (Lawrance \& Byers, 1992). The GMSEX is a 5-item measure of distress related to sexual functioning with one's partner.

  Change from baseline to post-intervention (5 weeks)

• Sexual correlates: GMSEX

  GMSEX (Lawrance \& Byers, 1992). The GMSEX is a 5-item measure of distress related to sexual functioning with one's partner.

  Change from post-intervention (5 weeks) to 6-month follow up

• Sexual correlates: Sexual activity scale

  This is a questionnaire developed by the study lead that asks individual to rate the frequency of times that 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.

  Change from baseline to post-intervention (5 weeks)

• Sexual correlates: Sexual activity scale

  This is a questionnaire developed by the study lead that asks individual to rate the frequency of times that 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.

  Change from post-intervention (5 weeks) to 6-month follow up

• Sexual correlates: Adapted dyadic adjustment scale

  Adapted dyadic adjustment scale (A-DAS; Sharpley \& Cross, 1982). The A-DAS is a validated, 7-item measure that assesses relationship adjustment.

  Change from baseline to post-intervention (5 weeks)

• Sexual correlates: Adapted dyadic adjustment scale

  Adapted dyadic adjustment scale (A-DAS; Sharpley \& Cross, 1982). The A-DAS is a validated, 7-item measure that assesses relationship adjustment.

  Change from post-intervention (5 weeks) to 6-month follow up

Secondary Outcomes (4)

• mental and health-related quality of life indices: Hospital Anxiety and Depression Scale

  Change from baseline to post-intervention (5 weeks)

• mental and health-related quality of life indices: Hospital Anxiety and Depression Scale

  Change from post-intervention (5 weeks) to 6-month follow up

• mental and health-related quality of life indices: UCLA Prostate Cancer Index

  Change from baseline to post-intervention (5 weeks)

• mental and health-related quality of life indices: UCLA Prostate Cancer Index

  Change from post-intervention (5 weeks) to 6-month follow up

Other Outcomes (10)

• Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form

  Change from baseline to post-intervention (5 weeks)

• Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form

  Change from post-intervention (5 weeks) to 6-month follow up

• Treatment mechanisms factors: Expectations for treatment

  Change from baseline to post-intervention (5 weeks)

Study Arms (2)

Immediate start

EXPERIMENTAL

Patients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment

Other: Mindfulness-based Therapy Group for Couples

Delayed start

OTHER

Patients begin the Mindfulness-based Therapy Group for Couples after a delay post-study enrollment (approximately 6 months)

Other: Mindfulness-based Therapy Group for Couples

Interventions

Mindfulness-based Therapy Group for Couples OTHER

Eligible couples will take part in a 4-session mindfulness-based therapy group for couples. The groups will last 2 hours in length, for a total of 8 hours of treatment time, and sessions will be scheduled once per week in successive weeks. The groups will have one highly experienced female facilitator, who is the Study Coordinator. The facilitator led the design of the treatment manual, and has experience in facilitating similar groups. The facilitator will follow a detailed, empirically-informed mindfulness-based treatment manual that was designed for the purpose of this study. All groups will take place in a private group treatment room at Vancouver General Hospital.

Delayed start; Immediate start

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vancouver Prostate Centre: lead

Study Sites (1)

Vancouver Prostate Centre

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Sexual Dysfunction, Physiological

Interventions

Family Characteristics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health

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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: June 6, 2017
• Study Start: January 24, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: October 2, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)