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Intimacy and Mindfulness Post-Prostate Cancer Treatment (IMPPACT)

Primary Purpose

Prostate Cancer, Sexual Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness-based Therapy Group for Couples
Sponsored by
Vancouver Prostate Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vancouver Prostate Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate start

Delayed start

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety..
mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety..
mental and health-related quality of life indices: UCLA Prostate Cancer Index
UCLA Prostate Cancer Index (Litwin, Hays, Fink, Ganz, Leake, & Brook, 1998). This is a 20-item measure that assesses health-related quality of life indices specific to common side effects of prostate cancer treatment.
mental and health-related quality of life indices: UCLA Prostate Cancer Index
UCLA Prostate Cancer Index (Litwin, Hays, Fink, Ganz, Leake, & Brook, 1998). This is a 20-item measure that assesses health-related quality of life indices specific to common side effects of prostate cancer treatment.

Full Information

First Posted
March 7, 2017
Last Updated
October 1, 2019
Sponsor
Vancouver Prostate Centre
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1. Study Identification

Unique Protocol Identification Number
NCT03177707
Brief Title
Intimacy and Mindfulness Post-Prostate Cancer Treatment
Acronym
IMPPACT
Official Title
Mindfulness-based Therapy Group Intervention for Couple's Dealing With Sexual Dysfunction After Prostate-cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vancouver Prostate Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Sexual Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate start
Arm Type
Experimental
Arm Description
Patients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment
Arm Title
Delayed start
Arm Type
Other
Arm Description
Patients begin the Mindfulness-based Therapy Group for Couples after a delay post-study enrollment (approximately 6 months)
Intervention Type
Other
Intervention Name(s)
Mindfulness-based Therapy Group for Couples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sexual correlates: Self-reported sexual functioning
Description
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)
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Sexual correlates: Self-reported erectile functioning
Description
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)
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
Sexual correlates: GMSEX
Description
GMSEX (Lawrance & Byers, 1992). The GMSEX is a 5-item measure of distress related to sexual functioning with one's partner.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Sexual correlates: GMSEX
Description
GMSEX (Lawrance & Byers, 1992). The GMSEX is a 5-item measure of distress related to sexual functioning with one's partner.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
Sexual correlates: Sexual activity scale
Description
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.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Sexual correlates: Sexual activity scale
Description
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.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
Sexual correlates: Adapted dyadic adjustment scale
Description
Adapted dyadic adjustment scale (A-DAS; Sharpley & Cross, 1982). The A-DAS is a validated, 7-item measure that assesses relationship adjustment.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Sexual correlates: Adapted dyadic adjustment scale
Description
Adapted dyadic adjustment scale (A-DAS; Sharpley & Cross, 1982). The A-DAS is a validated, 7-item measure that assesses relationship adjustment.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Secondary Outcome Measure Information:
Title
mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety..
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
Description
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety..
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
mental and health-related quality of life indices: UCLA Prostate Cancer Index
Description
UCLA Prostate Cancer Index (Litwin, Hays, Fink, Ganz, Leake, & Brook, 1998). This is a 20-item measure that assesses health-related quality of life indices specific to common side effects of prostate cancer treatment.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
mental and health-related quality of life indices: UCLA Prostate Cancer Index
Description
UCLA Prostate Cancer Index (Litwin, Hays, Fink, Ganz, Leake, & Brook, 1998). This is a 20-item measure that assesses health-related quality of life indices specific to common side effects of prostate cancer treatment.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Other Pre-specified Outcome Measures:
Title
Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form
Description
Five Facets of Mindfulness questionnaire; Short form (Bohlmeijer, E., P. M. ten Klooster, et al., 2011), which is a validated, 24-item measure of different aspects of attentiveness.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form
Description
Five Facets of Mindfulness questionnaire; Short form (Bohlmeijer, E., P. M. ten Klooster, et al., 2011), which is a validated, 24-item measure of different aspects of attentiveness.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
Treatment mechanisms factors: Expectations for treatment
Description
Expectations for treatment. A 4-item questionnaire, designed for and used in our approved mindfulness-based treatment study for women with provoked vestibulodynia
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Treatment mechanisms factors: Expectations for treatment,
Description
Expectations for treatment. A 4-item questionnaire, designed for and used in our approved mindfulness-based treatment study for women with provoked vestibulodynia
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
Treatment mechanisms factors: Time since prostate cancer treatment
Description
This is a single-item, face-valid question asking participants to indicate time since prostate cancer treatment. Responses will be cross-validated by comparing against partner response and also information gathered from their chart, if they were recruited through the Sexual Health Service.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Treatment mechanisms factors: Time since prostate cancer treatment
Description
This is a single-item, face-valid question asking participants to indicate time since prostate cancer treatment. Responses will be cross-validated by comparing against partner response and also information gathered from their chart, if they were recruited through the Sexual Health Service.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
Treatment mechanisms factors: Penile Rehabilitation Aids Use
Description
This questionnaire asks participants about their/their partner's use of penile rehabilitation aids, and their perception of these treatment usefulness will be asked.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Treatment mechanisms factors: Penile Rehabilitation Aids Use
Description
This questionnaire asks participants about their/their partner's use of penile rehabilitation aids, and their perception of these treatment usefulness will be asked.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up
Title
Treatment mechanisms factors: Mindfulness Practice
Description
This is a questionnaire designed by the experimenters to assess the amount of daily mindfulness practice. Participants will indicate the number of minutes they spent practicing each day. This log will be completed as a separate, online questionnaire that participants will access daily. Participants have the option of completing a paper-version of this log, which they will give to the Study Coordinator each week.
Time Frame
Change from baseline to post-intervention (5 weeks)
Title
Treatment mechanisms factors: Mindfulness Practice
Description
This is a questionnaire designed by the experimenters to assess the amount of daily mindfulness practice. Participants will indicate the number of minutes they spent practicing each day. This log will be completed as a separate, online questionnaire that participants will access daily. Participants have the option of completing a paper-version of this log, which they will give to the Study Coordinator each week.
Time Frame
Change from post-intervention (5 weeks) to 6-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Brotto, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver Prostate Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://prostatecentre.com/pcsc
Description
Prostate Cancer Supportive Care Program's website

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Intimacy and Mindfulness Post-Prostate Cancer Treatment

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