Impact of a Nurse-led Mind-body Intervention on Sexual Health for Young Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Vulvovaginal Symptoms Questionnaire (VSQ)
研究概览
简要总结
The goal of this clinical trial is to test the efficacy of a nurse-led psychoeducational sexual health intervention for young women breast cancer survivors. The main questions it aims to answer are:
- What is the feasibility of this intervention in an online, private setting?
- What is the effect of this intervention on reducing menopausal symptoms, improving sexual functioning, and enhancing body image?
Participants will participate in a nurse-led psychoeducational intervention for 8 sessions lasting approximately an hour each over the course of 8 - 10 weeks. Each participant will complete survey items at the beginning, end, and six-weeks after the last session. Participants will be compensated up to $150 in gift cards as a thank-you for their time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with breast cancer (stages I - III) between ages 18 - 50
- •Completed active treatment (chemotherapy and/or radiation) within the last five years
- •Can read/speak English
- •Access to talk in quiet, safe environment for privacy
- •On hormonal therapies (aromatase inhibitors, tamoxifen)
- •Currently partnered (i.e., in a relationship)
排除标准
- •Currently undergoing active treatment (chemotherapy and/or radiation)
- •More than five years have passed since completing active treatment (chemotherapy and/or radiation)
- •History of advanced breast cancer (stage IV) or a breast cancer recurrence
- •Women without access to the internet
- •Cannot read/speak in English
结局指标
主要结局
Vulvovaginal Symptoms Questionnaire (VSQ)
时间窗: Week 1, Week 16, Week 22
A 21-item survey designed to measure vaginal symptoms, emotions, life impact due to vulvovaginal symptoms, and sexual impact of vulvovaginal symptoms. The scores range from 0 - 20 with the higher score meaning greater impact from vulvovaginal symptoms.
Body Image Scale
时间窗: Week 1, Week 16, Week 22
A 10-item survey designed to measure body image changes after cancer treatment. Scores range from 0 - 30 with the higher scores representing more body image disturbances related to cancer treatment.
Female Sexual Functioning Index
时间窗: Week 1, Week 16, Week 22
A 19-item survey measuring female sexual functioning. Scores range from 2 - 36 with the higher score representing greater sexual function.
次要结局
未报告次要终点