Prostate CancerIMPPACTNCT03177707
Intimacy and Mindfulness Post-Prostate Cancer Treatment
A study testing Mindfulness-based Therapy Group for Couples in people with Prostate Cancer and Sexual Dysfunction, run by Vancouver Prostate Centre at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Prostate Cancer, Sexual Dysfunction
- What is being tested?
- Mindfulness-based Therapy Group for Couples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer, Sexual Dysfunction
- Being tested
- Mindfulness-based Therapy Group for Couples
- Medical subject headings
- Prostatic Neoplasms, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based Therapy Group for CouplesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate start | Experimental | Patients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment Receives: 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) Receives: Other: Mindfulness-based Therapy Group for Couples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety..
Measured: Change from baseline to post-intervention (5 weeks)
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..
Measured: Change from post-intervention (5 weeks) to 6-month follow up
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.
Measured: Change from baseline to post-intervention (5 weeks)
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.
Measured: Change from post-intervention (5 weeks) to 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start24 Jan 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver Prostate Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lori Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177707
- Sponsor's protocol ID
- IMPPACT
- Acronym
- IMPPACT
- Status last verified
- Oct 2019
- First submitted
- 7 Mar 2017
- Last updated
- 2 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Therapy Group Intervention for Couple's Dealing With Sexual Dysfunction After Prostate-cancer Treatment
- ClinicalTrials.gov ID
- NCT03177707
- Acronym / sponsor ID
- IMPPACT / IMPPACT
- Conditions
- Prostate Cancer, Sexual Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vancouver Prostate CentreUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate start | Experimental | Other: Mindfulness-based Therapy Group for CouplesPatients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment |
| Delayed start | Other | Other: Mindfulness-based Therapy Group for CouplesPatients begin the Mindfulness-based Therapy Group for Couples after a delay post-study enrollment (approximately 6 months) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based Therapy Group for CouplesEligible 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, Immediate start |
Primary outcome
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)
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)
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.
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.
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.
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.
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.
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.
4 secondary outcomes
mental and health-related quality of life indices: Hospital Anxiety and Depression Scale
Time frame: 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
mental and health-related quality of life indices: UCLA Prostate Cancer Index
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Brotto, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Therapy Group for Couples in people with Prostate Cancer and Sexual Dysfunction, run by Vancouver Prostate Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual correlates: Self-reported sexual functioning (time frame: Change from baseline to post-intervention (5 weeks)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.