Prostate CancerINTROSPPECTNCT03365518
Innovations in the Treatment of Sexual Health Post Prostate Cancer Treatment: Comparing Mindfulness vs. CBT
A study testing Cognitive Behavioural Therapy (CBT) and Mindfulness-Based Therapy in people with Prostate Cancer and Sexual Dysfunctions, Psychological, run by University of British Columbia at 1 site in Canada.
Trial summary
Up to 90% of men experience sexual difficulties after receiving treatment for prostate cancer (PC), which can negatively affect their intimate relationships and overall quality of life. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
- What is being tested?
- Cognitive Behavioural Therapy (CBT) and Mindfulness-Based Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 29 Dec 2017to 30 Nov 2020
- 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
- Healthy volunteers accepted
- 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
- (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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Gordon & Leslie Diamond Health Centre -- Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
About this study
Official title: Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer: A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy
Up to 90% of men experience sexual difficulties after receiving treatment for prostate cancer (PC), which can negatively affect their intimate relationships and overall quality of life. In this randomized clinical trial, the investigators will assess and compare two evidence-based treatments, mindfulness-based therapy and cognitive behavioral therapy (CBT), for couples with sexual complaints following PC treatment to controls who will receive no intervention.
Read the 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.
- Conditions
- Prostate Cancer, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological, Sexual Dysfunction Male, Relationships, Marital, Prostatic Neoplasms
- Being tested
- Cognitive Behavioural Therapy (CBT), Mindfulness-Based Therapy
- Keywords
- Psychological Treatment, Intimacy, Cognitive Behavioural Therapy, Cognitive Behavioral Therapy, Mindfulness, Group Therapy, Couples Therapy
- Medical subject headings
- Prostatic Neoplasms, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT)Behavioural
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.
Mindfulness-Based TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Experimental | 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. Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
| Mindfulness-Based Therapy | Experimental | 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. Receives: Behavioral: Mindfulness-Based Therapy |
| Control - Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in relationship satisfaction
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.
Measured: Baseline and Post Treatment (6 weeks)
Change in relationship satisfaction
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.
Measured: Baseline and Follow Up (6 months)
Change in sexual satisfaction/distress
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.
Measured: Baseline and Post Treatment (6 weeks)
Change in sexual satisfaction/distress
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.
Measured: Baseline and Follow Up (6 months)
Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)
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.
Measured: Baseline and Post Treatment (6 weeks)
Change in sexual functioning (one of three different questionnaires depending on the participant's demographics)
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.
Measured: Baseline and Follow Up (6 months)
Change in sexual behaviours
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.
Measured: Baseline and Post Treatment (6 weeks)
Change in sexual behaviours
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.
Measured: Baseline and Follow Up (6 months)
Secondary outcomes (6)
Change in psychological well-being
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.
Measured: Baseline and Post Treatment (6 weeks)
Change in psychological well-being
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.
Measured: Baseline and Follow Up (6 months)
Change in distress
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.
Measured: Baseline and Post Treatment (6 weeks)
Change in distress
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.
Measured: Baseline and Follow Up (6 months)
Change in quality of life
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.
Measured: Baseline and Post Treatment (6 weeks)
Change in quality of life
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.
Measured: Baseline and Follow Up (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start29 Dec 2017
- Primary completion30 Jun 2020
- Study completion30 Nov 2020
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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver Prostate Centre
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori Brotto, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365518
- Sponsor's protocol ID
- H17-02247
- Other IDs
- D2017-1893
- Acronym
- INTROSPPECT
- Status last verified
- Apr 2021
- First submitted
- 1 Dec 2017
- Last updated
- 27 Apr 2021
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer: A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy
- ClinicalTrials.gov ID
- NCT03365518
- Acronym / sponsor ID
- INTROSPPECT / H17-02247
- Conditions
- Prostate Cancer, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological, Sexual Dysfunction Male, Relationships, Marital, Prostatic Neoplasms
- Keywords
- Psychological Treatment, Intimacy, Cognitive Behavioural Therapy, Cognitive Behavioral Therapy, Mindfulness, Group Therapy, Couples Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver Prostate Centre
- Study start
- 29 Dec 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 7 Dec 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.
Up to 90% of men experience sexual difficulties after receiving treatment for prostate cancer (PC), which can negatively affect their intimate relationships and overall quality of life. In this randomized clinical trial, the investigators will assess and compare two evidence-based treatments, mindfulness-based therapy and cognitive behavioral therapy (CBT), for couples with sexual complaints following PC treatment to controls who will receive no intervention.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) | Experimental | Behavioral: 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. |
| Mindfulness-Based Therapy | Experimental | Behavioral: Mindfulness-Based TherapyTreatment 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. |
| Control - Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- 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
- (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
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Cognitive Behavioural Therapy (CBT)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. | Behavioural | Cognitive Behavioural Therapy (CBT) |
| Mindfulness-Based TherapyThe 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. | Behavioural | Mindfulness-Based Therapy |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
6 secondary outcomes
Change in psychological well-being
Time frame: Baseline and Post Treatment (6 weeks)
Change in psychological well-being
Time frame: Baseline and Follow Up (6 months)
Change in distress
Time frame: Baseline and Post Treatment (6 weeks)
Change in distress
Time frame: Baseline and Follow Up (6 months)
Change in quality of life
Time frame: Baseline and Post Treatment (6 weeks)
Change in quality of life
Time frame: Baseline and Follow Up (6 months)
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 27 Apr 2021.
- Vancouver Prostate Centre WebsiteLink provided by the sponsor.
- University of British Columbia Sexual Health Lab WebsiteLink provided by the sponsor.
- 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 Cognitive Behavioural Therapy (CBT) and Mindfulness-Based Therapy in people with Prostate Cancer and Sexual Dysfunctions, Psychological, run by University of British Columbia 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 1 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 27 Apr 2021. 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?
Change in relationship satisfaction (time frame: Baseline and Post Treatment (6 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 27 Apr 2021.