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| Name | Class |
|---|---|
| University of Calgary | OTHER |
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The purpose of this project is to compare the effects of a group mindfulness treatment versus a group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors. Participants will be randomly assigned to either 8 weekly sessions of a group mindfulness-based treatment or 8 weekly sessions of a sex education group. Groups will consist of approximately 8 breast cancer survivors and will be led by 2 trained therapists. Participants will complete four assessments (involving a clinician administered interview and standardized questions): pre-treatment, post- treatment, and 6 month follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT-S | Active Comparator | Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) which incorporates several empirically supported therapeutic approaches, integrating elements of education, mindfulness meditation skills, and sex therapy. |
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| SexEd | Active Comparator | Sexuality education on sexual desire, sexual distress, and sexual pain. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MBCT-S | Behavioral | Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors. |
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| Measure | Description | Time Frame |
|---|---|---|
| A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment | Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning. | Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment |
| A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 6 month follow-up | Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning. | Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up |
| No Change in Sexual Interest and Desire Female (SIDI-F) Score from 2 weeks' post-treatment (T2) and at 6 month follow-up (T3) | Sexual desire will be measured with the 13-item Sexual Interest and Desire Inventory which is a 14-item questionnaire that assesses sexual desire in women which includes one non-scored item assessing intercourse frequency. Possible total scores range from 0 - 51, with higher scores indicating higher levels of sexual functioning. | T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up |
| A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 2 weeks' post-treatment | Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress. | Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UBC Sexual Health Lab, Vancouver Hospital | Vancouver | British Columbia | V5M 1M9 | Canada |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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3-year, randomized, unblinded, two-site, controlled trial of 8 weekly sessions of group Mindfulness-Based Cognitive Therapy for sexuality (MBCT-S) vs. 8 weekly sessions of a sex education treatment.
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Those doing data analysis are blind
| SexEd | Behavioral | Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors. |
|
| A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 6 month follow-up | Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress. | Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up |
| No Change in Female Sexual Distress Scale - Revised (FSDS-R) Score from T2 at 2 weeks' post-treatment and at 6 month follow-up | Sexual distress will be assessed using the Female Sexual Distress Scale - Revised which is a 13-item scale where scores on the scale range from 0 - 52, where higher scores represent higher levels of distress. | T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up |
| A Change from Baseline Sexual Pain Rating Score at 2 weeks' post-treatment | Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration. | Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment |
| A Change from Baseline Sexual Pain Rating Score at 6 month follow-up | Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration. | Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up |
| No Change in Sexual Pain Rating Score from 2 weeks' post-treatment and at 6 month follow-up | Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration. | T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up |