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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.
This is an intervention study designed to assess a novel mindfulness-based treatment protocol for couples dealing with sexual dysfunction secondary to prostate cancer treatment. Couples will be invited to participate through the Vancouver Prostate Centre (VPC) and the Prostate Cancer Survivorship Care (PCSC) Program. Interested couples will be screened for eligibility. Eligible couples will be randomized to either an immediate-start or a delayed-waitlist control group.
Prior to treatment, couples will complete an online questionnaire package. Treatment will consist of a 4-week mindfulness-based group lead by a clinician trained in mindfulness treatment. Sessions are 2hrs in length and take place in consecutive weeks, with daily homework recommended between sessions. The intervention was developed based on pre-existing mindfulness-based cognitive therapy treatment groups for sexual dysfunction developed by Dr. Lori Brotto at the UBC Sexual Health Laboratory, mindfulness in sex therapy and intimate relationships (MSIR) treatment group developed by Kocsis and Newbury-Helps (2016), and expert input. Sessions consist of mindfulness-based training, sex therapy techniques, and education. After treatment, couples will be invited to complete a post-treatment questionnaire once immediately after the end of treatment, and again 6 months later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate start | Experimental | Patients begin the Mindfulness-based Therapy Group for Couples treatment group immediately after enrollment |
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| Delayed start | Other | Patients begin the Mindfulness-based Therapy Group for Couples after a delay post-study enrollment (approximately 6 months) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based Therapy Group for Couples | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | 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. | 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. | 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. | Change from baseline to post-intervention (5 weeks) |
| Sexual correlates: Sexual activity scale |
| Measure | Description | Time Frame |
|---|---|---|
| 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.. | Change from baseline to post-intervention (5 weeks) |
| mental and health-related quality of life indices: Hospital Anxiety and Depression Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form | Five Facets of Mindfulness questionnaire; Short form (Bohlmeijer, E., P. M. ten Klooster, et al., 2011), which is a validated, 24-item measure of different aspects of attentiveness. | Change from baseline to post-intervention (5 weeks) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Brotto, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vancouver Prostate Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D005191 | Family Characteristics |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
| D015991 | Epidemiologic Measurements |
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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.
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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. |
| 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. | 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. | Change from post-intervention (5 weeks) to 6-month follow up |
Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983). The HADS is a validated, 14-item measure of depression and anxiety.. |
| 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. | 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. | Change from post-intervention (5 weeks) to 6-month follow up |
| Treatment mechanisms factors: Five Facets of Mindfulness questionnaire Short form |
Five Facets of Mindfulness questionnaire; Short form (Bohlmeijer, E., P. M. ten Klooster, et al., 2011), which is a validated, 24-item measure of different aspects of attentiveness. |
| Change from post-intervention (5 weeks) to 6-month follow up |
| Treatment mechanisms factors: Expectations for treatment | Expectations for treatment. A 4-item questionnaire, designed for and used in our approved mindfulness-based treatment study for women with provoked vestibulodynia | Change from baseline to post-intervention (5 weeks) |
| Treatment mechanisms factors: Expectations for treatment, | Expectations for treatment. A 4-item questionnaire, designed for and used in our approved mindfulness-based treatment study for women with provoked vestibulodynia | Change from post-intervention (5 weeks) to 6-month follow up |
| Treatment mechanisms factors: Time since prostate cancer treatment | This is a single-item, face-valid question asking participants to indicate time since prostate cancer treatment. Responses will be cross-validated by comparing against partner response and also information gathered from their chart, if they were recruited through the Sexual Health Service. | Change from baseline to post-intervention (5 weeks) |
| Treatment mechanisms factors: Time since prostate cancer treatment | This is a single-item, face-valid question asking participants to indicate time since prostate cancer treatment. Responses will be cross-validated by comparing against partner response and also information gathered from their chart, if they were recruited through the Sexual Health Service. | Change from post-intervention (5 weeks) to 6-month follow up |
| Treatment mechanisms factors: Penile Rehabilitation Aids Use | This questionnaire asks participants about their/their partner's use of penile rehabilitation aids, and their perception of these treatment usefulness will be asked. | Change from baseline to post-intervention (5 weeks) |
| Treatment mechanisms factors: Penile Rehabilitation Aids Use | This questionnaire asks participants about their/their partner's use of penile rehabilitation aids, and their perception of these treatment usefulness will be asked. | Change from post-intervention (5 weeks) to 6-month follow up |
| Treatment mechanisms factors: Mindfulness Practice | This is a questionnaire designed by the experimenters to assess the amount of daily mindfulness practice. Participants will indicate the number of minutes they spent practicing each day. This log will be completed as a separate, online questionnaire that participants will access daily. Participants have the option of completing a paper-version of this log, which they will give to the Study Coordinator each week. | Change from baseline to post-intervention (5 weeks) |
| Treatment mechanisms factors: Mindfulness Practice | This is a questionnaire designed by the experimenters to assess the amount of daily mindfulness practice. Participants will indicate the number of minutes they spent practicing each day. This log will be completed as a separate, online questionnaire that participants will access daily. Participants have the option of completing a paper-version of this log, which they will give to the Study Coordinator each week. | Change from post-intervention (5 weeks) to 6-month follow up |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011634 |
| Public Health |
| D004778 | Environment and Public Health |