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Intimacy and Mindfulness Post-Prostate Cancer Treatment (IMPPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03177707
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Vancouver Prostate Centre

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Sexual Dysfunction Other: Mindfulness-based Therapy Group for Couples Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Mindfulness-based Therapy Group Intervention for Couple's Dealing With Sexual Dysfunction After Prostate-cancer Treatment
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : May 31, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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.


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.





Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  1. 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..

  2. 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..

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177707


Locations
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Canada, British Columbia
Vancouver Prostate Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
Vancouver Prostate Centre
Investigators
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Principal Investigator: Lori Brotto, PhD University of British Columbia

Additional Information:
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Responsible Party: Vancouver Prostate Centre
ClinicalTrials.gov Identifier: NCT03177707     History of Changes
Other Study ID Numbers: IMPPACT
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases