Prostate Cancer Clinical Trial
— INTROSPPECTOfficial title:
Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer: A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy
Verified date | April 2021 |
Source | University of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | November 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Gordon & Leslie Diamond Health Centre -- Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia | Vancouver Prostate Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Mindfulness | 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) | |
Other | Change in Mindfulness | 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) | |
Other | Mindfulness (moderator) | 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 | |
Other | Mindfulness (moderator) | 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) | |
Other | Mindfulness (moderator) | 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) | |
Other | Expectations for treatment (moderator) | 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 | |
Other | Expectations for treatment (moderator) | 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) | |
Other | Expectations for treatment (moderator) | 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 | |
Other | Therapeutic Skills Practice (moderator) | 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 | |
Other | Therapeutic Skills Practice (moderator) | 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 | |
Other | Big Five Inventory-10 (moderator) | 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 | |
Other | Pre-treatment sexual functioning (moderator) | 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 | |
Other | Time elapsed since treatment (moderator) | 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) | |
Primary | 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. | Baseline and Post Treatment (6 weeks) | |
Primary | 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. | Baseline and Follow Up (6 months) | |
Primary | 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. | Baseline and Post Treatment (6 weeks) | |
Primary | 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. | Baseline and Follow Up (6 months) | |
Primary | 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. |
Baseline and Post Treatment (6 weeks) | |
Primary | 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. |
Baseline and Follow Up (6 months) | |
Primary | 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. | Baseline and Post Treatment (6 weeks) | |
Primary | 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. | Baseline and Follow Up (6 months) | |
Secondary | 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. | Baseline and Post Treatment (6 weeks) | |
Secondary | 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. | Baseline and Follow Up (6 months) | |
Secondary | 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. | Baseline and Post Treatment (6 weeks) | |
Secondary | 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. | Baseline and Follow Up (6 months) | |
Secondary | 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. | Baseline and Post Treatment (6 weeks) | |
Secondary | 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. | Baseline and Follow Up (6 months) |
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