- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03365518
Innovations in the Treatment of Sexual Health Post Prostate Cancer Treatment: Comparing Mindfulness vs. CBT (INTROSPPECT)
Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer: A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial is designed to assess and compare efficacy of two treatment manuals for couples with sexual difficulties secondary to PC treatment: mindfulness-based therapy and CBT. A third arm, where couples receive no intervention will act as a control group. Those randomized to the "control" group will have the opportunity to be randomized to one of the treatment groups following their third and final questionnaire if they wish.
Men and their partners will be invited to participate through the Vancouver Prostate Centre's Prostate Cancer Supportive Care Program (PCSC) at Vancouver General Hospital.
Eligible couples will be randomized to either: 4 consecutive weeks of mindfulness-based therapy, CBT, or no intervention (4-6 couples in each treatment group at a time). All participants will complete an online questionnaire package to assess primary, secondary, and tertiary outcomes at the time of study enrollment or baseline (Time 1). All participants will be invited to complete a Time 2 questionnaire once approximately 6 weeks after they complete the Time 1 questionnaire (for couples randomized to the treatment arms, this will be immediately post-treatment). Finally, all participants will be invited to complete the Time 3 follow up questionnaire 6 months after they complete the Time 2 (post-treatment) questionnaire.
Endpoints will assess effects on intimacy and overall Quality of Life. Additional endpoints of other factors affecting improvement (i.e., moderators like personality and treatment adherence) will be assessed. The investigators predict improvements in both mindfulness-based and cognitive behavioural therapy treatments; moderators will provide insights into which participants benefit most from each treatment arm.
Moreover, in order to improve understanding of the lived experience of patients who take part in the treatment groups or control arm, this study will invite all participants to take part in an exit interview after their Time 2 (post-treatment) questionnaire is completed. A research team member who was not a treatment facilitator will conduct the exit interviews. This information will then be transcribed and used for qualitative data analyses.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Gordon & Leslie Diamond Health Centre -- Vancouver General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
- (At least) one member of the couple has a history of prostate cancer diagnosis
- The same member of the couple underwent treatment (e.g., radical prostatectomy, radiation therapy, Androgen Deprivation Therapy) for their prostate cancer or is on active surveillance
- The member of the couple who underwent treatment for prostate cancer is experiencing distress related to his current level of intimacy/sexual well-being
- Both members of the couple are willing and able to comply with all study procedures and be available for the duration of the study. Commitment includes a total of 5.5 hours per week in sessions and daily homework over the 4-week period of the treatment program for those randomized to receive treatment
- Both members of the couple are fluent in English
Exclusion Criteria:
- Have a current health condition (e.g., severe cardiovascular health problems, unmanaged diabetes mellitus), physical disability and/or a significant, unmanaged major mental illness (e.g., unmanaged bipolar disorder, psychosis) that would interfere with self- or partnered-sexual activities, or the individual's ability to attend group sessions or complete home assignments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Behavioural Therapy (CBT)
Treatment will consist of a 4-week group lead by a trained clinician.
Sessions are 2 hours in length and take place in consecutive weeks, with daily homework recommended between sessions.
|
Sessions consist of CBT tools as well as sex therapy techniques and education.
The CBT treatment was adapted from the mindfulness-based treatment, but all mentions of mindfulness have been replaced with CBT principles.
The therapeutic content presented in this treatment arm is manualized.
|
Experimental: Mindfulness-Based Therapy
Treatment will consist of a 4-week group lead by a trained clinician.
Sessions are 2 hours in length and take place in consecutive weeks, with daily homework recommended between sessions.
|
The mindfulness-based treatment was developed based on pre-existing mindfulness-based cognitive therapy treatment groups for sexual dysfunction developed by Dr. Lori Brotto at the University of British Columbia 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 as well as sex therapy techniques and education.
The therapeutic content presented in this treatment arm is manualized.
|
No Intervention: Control - Usual Care
Participants who are randomized to the control group will not receive mindfulness or CBT treatment. They will proceed with the course of treatment they were receiving prior to enrollment in the study. As resources for couples dealing with changes to their sexual lives after prostate cancer are limited, it is anticipated that the majority of these patients will have no treatment targeting sexual intimacy during the 6-week period between completing the first and second questionnaire. Those randomized to the "control" group will have the opportunity to be randomized to one of the treatment groups following their third and final questionnaire if they wish. In this case, they will be issued an additional participant ID within one of the treatment groups. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in relationship satisfaction
Time Frame: Baseline and Post Treatment (6 weeks)
|
Adapted dyadic adjustment scale (A-DAS).
The A-DAS is a validated, 7-item measure that assesses relationship adjustment.
Total scores range from 0-36 with higher scores indicating greater dyadic adjustment.
|
Baseline and Post Treatment (6 weeks)
|
Change in relationship satisfaction
Time Frame: Baseline and Follow Up (6 months)
|
Adapted dyadic adjustment scale (A-DAS).
The A-DAS is a validated, 7-item measure that assesses relationship adjustment.
Total scores range from 0-36 with higher scores indicating greater dyadic adjustment.
|
Baseline and Follow Up (6 months)
|
Change in sexual satisfaction/distress
Time Frame: Baseline and Post Treatment (6 weeks)
|
Female sexual distress scale - revised (FSDS-R).
The FSDS-R is a 13-item measure that assesses sexual distress.
Although named for its use with women, this measure has been validated as a measure of sexual distress in women and men.
Each item is rated on a scale of 0-4.
The total score is a summation, ranging from 0 to 52, and provides a measure of sexual distress in which higher scores represent higher levels of sexual distress.
|
Baseline and Post Treatment (6 weeks)
|
Change in sexual satisfaction/distress
Time Frame: Baseline and Follow Up (6 months)
|
Female sexual distress scale - revised (FSDS-R).
The FSDS-R is a 13-item measure that assesses sexual distress.
Although named for its use with women, this measure has been validated as a measure of sexual distress in women and men.
Each item is rated on a scale of 0-4.
The total score is a summation, ranging from 0 to 52, and provides a measure of sexual distress in which higher scores represent higher levels of sexual distress.
|
Baseline and Follow Up (6 months)
|
Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)
Time Frame: Baseline and Post Treatment (6 weeks)
|
International Index of Erectile Functioning (IIEF) is a 15-item self-reported scale of men's sexual functioning. The scale has five domains: Erectile Function, Intercourse Satisfaction; Orgasmic Function, Overall Satisfaction, and Sexual Desire with ranges 1-30, 0-15, 0-10, 2-10, and 2-10 respectively. Total scores (sum) range from 5-75. Lower domain and total scores denote lower sexual function. OR International Index of Erectile Functioning for Men who have sex with men (IIEF-MSM) is a 22-item measure of sexual function. Total scores (sum) range from 0-95; lower scores indicate lower sexual function. OR Female Sexual Functioning Index (FSFI) is a 19-item measure of self-reported sexual dysfunction in women. The scale includes six domains with the following ranges: 1.2-6 for desire; 0-6 for arousal, lubrication, orgasm, and pain; and 0.8-6 satisfaction. Total scores (sum) range from 2 to 36. Lower domain and total scores indicate lower sexual functioning. |
Baseline and Post Treatment (6 weeks)
|
Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)
Time Frame: Baseline and Follow Up (6 months)
|
International Index of Erectile Functioning (IIEF) is a 15-item self-reported scale of men's sexual functioning. The scale has five domains: Erectile Function, Intercourse Satisfaction; Orgasmic Function, Overall Satisfaction, and Sexual Desire with ranges 1-30, 0-15, 0-10, 2-10, and 2-10 respectively. Total scores (sum) range from 5-75. Lower domain and total scores denote lower sexual function. OR International Index of Erectile Functioning for Men who have sex with men (IIEF-MSM) is a 22-item measure of sexual function. Total scores (sum) range from 0-95; lower scores indicate lower sexual function. OR Female Sexual Functioning Index (FSFI) is a 19-item measure of self-reported sexual dysfunction in women. The scale includes six domains with the following ranges: 1.2-6 for desire; 0-6 for arousal, lubrication, orgasm, and pain; and 0.8-6 satisfaction. Total scores (sum) range from 2 to 36. Lower domain and total scores indicate lower sexual functioning. |
Baseline and Follow Up (6 months)
|
Change in sexual behaviours
Time Frame: Baseline and Post Treatment (6 weeks)
|
Sexual activity scale.
This is a questionnaire developed by the study lead that asks individuals to indicate whether 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.
There are 15 items on this scale which can be indicated over the three time periods mentioned previously.
By tallying the categorical answers (yes or no), total scores can range from 0 to 45 with higher scores indicating greater sexual activity engaged.
Subset scores at each time point range from 0-15 and indicate sexual activity in the same way as the total score.
|
Baseline and Post Treatment (6 weeks)
|
Change in sexual behaviours
Time Frame: Baseline and Follow Up (6 months)
|
Sexual activity scale.
This is a questionnaire developed by the study lead that asks individuals to indicate whether 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.
There are 15 items on this scale which can be indicated over the three time periods mentioned previously.
By tallying the categorical answers (yes or no), total scores can range from 0 to 45 with higher scores indicating greater sexual activity engaged.
Subset scores at each time point range from 0-15 and indicate sexual activity in the same way as the total score.
|
Baseline and Follow Up (6 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in psychological well-being
Time Frame: Baseline and Post Treatment (6 weeks)
|
Hospital Anxiety and Depression Scale (HADS).
The HADS is a validated, 14-item measure of depression and anxiety.
Total scores range from 0-42, composed of the sum of two sub-scales for anxiety and depression both ranging from 0-21.
Higher scores indicate higher levels of anxiety and/or depression symptoms.
|
Baseline and Post Treatment (6 weeks)
|
Change in psychological well-being
Time Frame: Baseline and Follow Up (6 months)
|
Hospital Anxiety and Depression Scale (HADS).
The HADS is a validated, 14-item measure of depression and anxiety.
Total scores range from 0-42, composed of the sum of two sub-scales for anxiety and depression both ranging from 0-21.
Higher scores indicate higher levels of anxiety and/or depression symptoms.
|
Baseline and Follow Up (6 months)
|
Change in distress
Time Frame: Baseline and Post Treatment (6 weeks)
|
Distress Thermometer.
The distress thermometer is a single-item distress screening scale, which has been shown to be a valid measure of cancer-specific distress among prostate cancer patients and their partners.
Participants indicate their current level of distress on an 11-point scale from 0-10 with 0 being no distress and 10 being extreme distress.
|
Baseline and Post Treatment (6 weeks)
|
Change in distress
Time Frame: Baseline and Follow Up (6 months)
|
Distress Thermometer.
The distress thermometer is a single-item distress screening scale, which has been shown to be a valid measure of cancer-specific distress among prostate cancer patients and their partners.
Participants indicate their current level of distress on an 11-point scale from 0-10 with 0 being no distress and 10 being extreme distress.
|
Baseline and Follow Up (6 months)
|
Change in quality of life
Time Frame: Baseline and Post Treatment (6 weeks)
|
World Health Organization Quality of Life - Brief Form (WHOQOL-BREF).
This is a 26-item measure that assesses overall quality of life in four domains of physical health, psychological well-being, social relationships, and environmental well-being.
The four domains score with a range from 4-20 with higher scores representing higher quality of life in each domain.
|
Baseline and Post Treatment (6 weeks)
|
Change in quality of life
Time Frame: Baseline and Follow Up (6 months)
|
World Health Organization Quality of Life - Brief Form (WHOQOL-BREF).
This is a 26-item measure that assesses overall quality of life in four domains of physical health, psychological well-being, social relationships, and environmental well-being.
The four domains score with a range from 4-20 with higher scores representing higher quality of life in each domain.
|
Baseline and Follow Up (6 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Mindfulness
Time Frame: Baseline and Post Treatment (6 weeks)
|
Five Facets of Mindfulness questionnaire; Short form, which is a validated, 24-item measure of different aspects of mindfulness.
There are five subscales: non-reactivity, observing, acting with awareness, describing, and non-judging.
Sub-scale scores range from 5-25 for non-reactivity, acting with awareness, describing, and non-judging, and 5-20 for observing.
Higher scores indicate greater levels of the respective facet of mindfulness.
|
Baseline and Post Treatment (6 weeks)
|
Change in Mindfulness
Time Frame: Baseline and Follow Up (6 months)
|
Five Facets of Mindfulness questionnaire; Short form, which is a validated, 24-item measure of different aspects of mindfulness.
There are five subscales: non-reactivity, observing, acting with awareness, describing, and non-judging.
Sub-scale scores range from 5-25 for non-reactivity, acting with awareness, describing, and non-judging, and 5-20 for observing.
Higher scores indicate greater levels of the respective facet of mindfulness.
|
Baseline and Follow Up (6 months)
|
Mindfulness (moderator)
Time Frame: Baseline
|
Five Facets of Mindfulness questionnaire; Short form, which is a validated, 24-item measure of different aspects of mindfulness.
There are five subscales: non-reactivity, observing, acting with awareness, describing, and non-judging.
Sub-scale scores range from 5-25 for non-reactivity, acting with awareness, describing, and non-judging, and 5-20 for observing.
Higher scores indicate greater levels of the respective facet of mindfulness.
|
Baseline
|
Mindfulness (moderator)
Time Frame: Post-Treatment (Week 6)
|
Five Facets of Mindfulness questionnaire; Short form, which is a validated, 24-item measure of different aspects of mindfulness.
There are five subscales: non-reactivity, observing, acting with awareness, describing, and non-judging.
Sub-scale scores range from 5-25 for non-reactivity, acting with awareness, describing, and non-judging, and 5-20 for observing.
Higher scores indicate greater levels of the respective facet of mindfulness.
|
Post-Treatment (Week 6)
|
Mindfulness (moderator)
Time Frame: Follow-Up (6 Months)
|
Five Facets of Mindfulness questionnaire; Short form, which is a validated, 24-item measure of different aspects of mindfulness.
There are five subscales: non-reactivity, observing, acting with awareness, describing, and non-judging.
Sub-scale scores range from 5-25 for non-reactivity, acting with awareness, describing, and non-judging, and 5-20 for observing.
Higher scores indicate greater levels of the respective facet of mindfulness.
|
Follow-Up (6 Months)
|
Expectations for treatment (moderator)
Time Frame: Baseline for Treatment Groups
|
A 4-item questionnaire, designed for and used in a previous mindfulness-based treatment study for women with provoked vestibulodynia.
Scores for each item range from 0-10, with higher scores indicating a greater expectation for the treatment to be effective and greater motivation to complete the treatment and assignments.
|
Baseline for Treatment Groups
|
Expectations for treatment (moderator)
Time Frame: Post-Treatment (Week 6)
|
A 4-item questionnaire, designed for and used in a previous mindfulness-based treatment study for women with provoked vestibulodynia.
Scores for each item range from 0-10, with higher scores indicating a greater expectation for the treatment to be effective and greater motivation to complete the treatment and assignments.
|
Post-Treatment (Week 6)
|
Expectations for treatment (moderator)
Time Frame: Follow-Up (6 Months) for Treatment Groups
|
A 4-item questionnaire, designed for and used in a previous mindfulness-based treatment study for women with provoked vestibulodynia.
Scores for each item range from 0-10, with higher scores indicating a greater expectation for the treatment to be effective and greater motivation to complete the treatment and assignments.
|
Follow-Up (6 Months) for Treatment Groups
|
Therapeutic Skills Practice (moderator)
Time Frame: Week 1-4 for Treatment Groups
|
This is a questionnaire designed by the experimenters to assess the amount that participants practice the skills taught in treatment daily.
Participants will indicate the skills practiced each day, and number of minutes they spent practicing each skill.
This will be expressed as total number of minutes or an average of minutes per day.
|
Week 1-4 for Treatment Groups
|
Therapeutic Skills Practice (moderator)
Time Frame: Follow-Up (6 Months) for Treatment Groups
|
This is a questionnaire designed by the experimenters to assess the amount that participants practice the skills taught in treatment.
Participants will indicate the skills practiced each day, and number of minutes they spent practicing each skill.
This will be expressed as total number of minutes or an average of minutes per day.
|
Follow-Up (6 Months) for Treatment Groups
|
Big Five Inventory-10 (moderator)
Time Frame: Baseline
|
Big Five Inventory-10.
An adapted, brief 10-item measure of personality characteristics.
Scores range from 2-10 on the five personality traits of openness to experience, conscientiousness, extroversion, agreeableness, and neuroticism.
Higher scores indicate higher levels of the respective trait.
|
Baseline
|
Pre-treatment sexual functioning (moderator)
Time Frame: Baseline
|
This is an experimenter derived questionnaire asking participants to indicate if they have a history of sexual dysfunction that preceded their own/their partner's prostate cancer treatments.
Items are scored on a range from 0-5, with higher scores denoting greater sexual dysfunction.
Total number of items varies as participants are able to specify more dysfunction symptoms.
|
Baseline
|
Time elapsed since treatment (moderator)
Time Frame: Baseline and Follow-Up (6 Months)
|
This measure will review date of prostate cancer diagnosis and the time elapsed from treatment to enrollment.
This will be reviewed at 6 Months to capture any changes in treatment.
|
Baseline and Follow-Up (6 Months)
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H17-02247
- D2017-1893 (Other Grant/Funding Number: Movember Discovery Grant/Prostate Cancer Canada)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Prostatic Neoplasms
-
Australian and New Zealand Urogenital and Prostate...Peter MacCallum Cancer Centre, AustraliaRecruitingCastration Resistant Prostatic CancerAustralia
-
Technische Universität DresdenRecruitingOligometastatic Disease | Prostatic Cancer, Castration-ResistantGermany
-
British Columbia Cancer AgencySanofi; Ozmosis Research Inc.UnknownMetastatic Castration-Resistant Prostatic CancerCanada, Australia
-
Janssen Research & Development, LLCCompletedCastration-Resistant Prostatic NeoplasmsCanada, Belgium, United States, Spain, Netherlands, Italy, Russian Federation
-
Universität des SaarlandesRecruitingProstate Cancer Metastatic | Advanced Prostate Carcinoma | Castration Resistant Prostatic CancerGermany
-
Yinghao SunNot yet recruitingCastration-Resistant Prostatic Cancer
-
Institut Claudius RegaudWithdrawnProstatic Cancer, Castration-ResistantFrance
-
University Hospital, GrenobleTerminatedCastration-resistant Prostate CancerFrance
-
Michael Graham PhD, MDUniversity of Iowa; Holden Comprehensive Cancer CenterActive, not recruitingProstate Cancer | Prostatic Neoplasms, Castration-Resistant | Prostatic Neoplasm | Prostatic Cancer Recurrent | Prostatic Cancer MetastaticUnited States
-
Rio de Janeiro State UniversityCompletedProstatic Cancer | Prostatic NeoplasmBrazil
Clinical Trials on Cognitive Behavioural Therapy (CBT)
-
The University of Hong KongChinese University of Hong Kong; University of OxfordCompletedDepression | InsomniaHong Kong
-
Linkoeping UniversityCompleted
-
University Medicine GreifswaldGerman Federal Ministry of Education and ResearchUnknown
-
University of British ColumbiaHarvard Medical School (HMS and HSDM)Active, not recruitingMild Traumatic Brain Injury | Functional Neurological DisorderCanada
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); Orthopaedic Trauma AssociationRecruitingPain, Postoperative | Pain, Acute | Fractures, Closed | Pain, Chronic | Fractures, OpenUnited States, Canada
-
McMaster UniversityCanadian Institutes of Health Research (CIHR)Completed
-
Nova Scotia Health AuthorityCompletedBipolar Disorder | Social PhobiaCanada
-
McMaster UniversityUnity Health Toronto; Hamilton Health Sciences Corporation; Hamilton Academic...TerminatedPain, Postoperative | Fractures, Closed | Fractures, OpenCanada
-
Charite University, Berlin, GermanyGerman Federal Ministry of Education and ResearchCompletedPanic Disorder | Agoraphobia
-
Royal Victoria InfirmaryManchester University NHS Foundation TrustUnknownCough | Idiopathic Pulmonary Fibrosis | BreathlessnessUnited Kingdom