Intimacy and Mindfulness Post-Prostate Cancer Treatment (IMPPACT)

October 1, 2019 updated by: Vancouver Prostate Centre

Mindfulness-based Therapy Group Intervention for Couple's Dealing With Sexual Dysfunction After Prostate-cancer Treatment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Prostate Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate start
Patients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment
Other: Mindfulness-based Therapy Group for Couples

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.
Other: Delayed start
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

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sexual correlates: Self-reported sexual functioning
Time Frame: Change from baseline to post-intervention (5 weeks)
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
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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
Time Frame: Change from baseline to post-intervention (5 weeks)
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
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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
Time Frame: Change from baseline to post-intervention (5 weeks)
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
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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
Time Frame: Change from baseline to post-intervention (5 weeks)
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
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
Time Frame: Change from baseline to post-intervention (5 weeks)
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety..
Change from baseline to post-intervention (5 weeks)
mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety..
Change from post-intervention (5 weeks) to 6-month follow up
mental and health-related quality of life indices: UCLA Prostate Cancer Index
Time Frame: Change from baseline to post-intervention (5 weeks)
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.
Change from baseline to post-intervention (5 weeks)
mental and health-related quality of life indices: UCLA Prostate Cancer Index
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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.
Change from post-intervention (5 weeks) to 6-month follow up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form
Time Frame: Change from baseline to post-intervention (5 weeks)
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.
Change from baseline to post-intervention (5 weeks)
Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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.
Change from post-intervention (5 weeks) to 6-month follow up
Treatment mechanisms factors: Expectations for treatment
Time Frame: Change from baseline to post-intervention (5 weeks)
Expectations for treatment. A 4-item questionnaire, designed for and used in our approved mindfulness-based treatment study for women with provoked vestibulodynia
Change from baseline to post-intervention (5 weeks)
Treatment mechanisms factors: Expectations for treatment,
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
Expectations for treatment. A 4-item questionnaire, designed for and used in our approved mindfulness-based treatment study for women with provoked vestibulodynia
Change from post-intervention (5 weeks) to 6-month follow up
Treatment mechanisms factors: Time since prostate cancer treatment
Time Frame: Change from baseline to post-intervention (5 weeks)
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.
Change from baseline to post-intervention (5 weeks)
Treatment mechanisms factors: Time since prostate cancer treatment
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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.
Change from post-intervention (5 weeks) to 6-month follow up
Treatment mechanisms factors: Penile Rehabilitation Aids Use
Time Frame: Change from baseline to post-intervention (5 weeks)
This questionnaire asks participants about their/their partner's use of penile rehabilitation aids, and their perception of these treatment usefulness will be asked.
Change from baseline to post-intervention (5 weeks)
Treatment mechanisms factors: Penile Rehabilitation Aids Use
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
This questionnaire asks participants about their/their partner's use of penile rehabilitation aids, and their perception of these treatment usefulness will be asked.
Change from post-intervention (5 weeks) to 6-month follow up
Treatment mechanisms factors: Mindfulness Practice
Time Frame: Change from baseline to post-intervention (5 weeks)
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.
Change from baseline to post-intervention (5 weeks)
Treatment mechanisms factors: Mindfulness Practice
Time Frame: Change from post-intervention (5 weeks) to 6-month follow up
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.
Change from post-intervention (5 weeks) to 6-month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vancouver Prostate Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMPPACT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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