BREast Cancer And Sexuality Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer

Conditions
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Sexual Dysfunction

Intervention / Treatment
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* Behavioral: MBCT-S
* Behavioral: SexEd


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women over the age of majority, with a history of breast cancer and who are at least 3 months following the end of their treatment Fluent in English Exceed the clinical cut-off for sexual distress (Female Sexual Distress Scale). Women who are, and who are not, in a relationship will be eligible as long as they have engaged in sexual activity either alone or with a sexual partner in the past 6 months, or as long as they indicate a willingness to engage in sexual activity (alone or with a sexual partner) during the time period of the study. Exclusion Criteria: Active cancer treatment (e.g. chemotherapy or radiation, not including endocrine or maintenance therapies provided they remain constant for the study duration), or scheduled breast reconstruction during the study period. Borderline Personality Disorder or other psychiatric or medical conditions that preclude the ability to fully participate in the group sessions, assessments, and homework. In order to determine whether any changes in symptoms are a result of participation in the intervention, women must also agree to 1) not make changes to or commence vaginal interventions (e.g., topical hormone treatments, vaginal moisturizers, vaginal dilation) or 2) engage in other treatments for sexual difficulties (e.g., sex therapy), for 2 weeks prior to the baseline assessment until 2 weeks following the final intervention session.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MBCT-S<br>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. | Behavioral: MBCT-S<br>* Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.<br>|
| Active Comparator: SexEd<br>Sexuality education on sexual desire, sexual distress, and sexual pain. | Behavioral: SexEd<br>* Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| 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 |