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Intimacy and Mindfulness Post-Prostate Cancer Treatment (IMPPACT)

V

Vancouver Prostate Centre (VPC)

Status

Completed

Conditions

Sexual Dysfunction
Prostate Cancer

Treatments

Other: Mindfulness-based Therapy Group for Couples

Study type

Interventional

Funder types

Other

Identifiers

NCT03177707
IMPPACT

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 2 patient groups

Immediate start
Experimental group
Description:
Patients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment
Treatment:
Other: Mindfulness-based Therapy Group for Couples
Delayed start
Other group
Description:
Patients begin the Mindfulness-based Therapy Group for Couples after a delay post-study enrollment (approximately 6 months)
Treatment:
Other: Mindfulness-based Therapy Group for Couples

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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