Mindfulness-based Treatment for Sexual Difficulties Following Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 6 month follow-up
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Those doing data analysis are blind
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 6 month follow-up
时间窗: Baseline/T1 is within 2 weeks pre-treatment and T3 is 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.
A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 2 weeks' post-treatment
时间窗: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 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.
A Change from Baseline Sexual Interest and Desire Female (SIDI-F) Score at 6 month follow-up
时间窗: Baseline/T1 is within 2 weeks pre-treatment and T3 is 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.
No Change in Sexual Interest and Desire Female (SIDI-F) Score from 2 weeks' post-treatment (T2) and at 6 month follow-up (T3)
时间窗: T2 is within 2 weeks post-treatment and T3 is 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.
No Change in Female Sexual Distress Scale - Revised (FSDS-R) Score from T2 at 2 weeks' post-treatment and at 6 month follow-up
时间窗: T2 is within 2 weeks post-treatment and T3 is 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.
A Change from Baseline Sexual Pain Rating Score at 6 month follow-up
时间窗: Baseline/T1 is within 2 weeks pre-treatment and T3 is at 6 month follow-up
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
A Change from Baseline Female Sexual Distress Scale - Revised (FSDS-R) Score at 2 weeks' post-treatment
时间窗: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 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.
A Change from Baseline Sexual Pain Rating Score at 2 weeks' post-treatment
时间窗: Baseline/T1 is within 2 weeks pre-treatment and T2 is within 2 weeks post-treatment
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
No Change in Sexual Pain Rating Score from 2 weeks' post-treatment and at 6 month follow-up
时间窗: T2 is within 2 weeks post-treatment and T3 is at 6 month follow-up
Numeric Rating Scale of 0-10 (from no pain to worst possible pain) in response to vaginal penetration.
次要结局
未报告次要终点
研究者
Lori Brotto
Principal Investigator
University of British Columbia