Sexual Health and Rehabilitation Online (SHAREonline): An Educational Intervention for Young Adult Women After Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Sexual Function
研究概览
简要总结
SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function.
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
详细描述
The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.
Participants in this study would first complete health questionnaires and then be randomized to take part in one of two types of education sessions delivered by an instructor over videoconference: 1) Group education session or 2) Individual self-management session.
About 56 women will receive the group education session and about 28 will receive the individual self-management session.
It is expected that about 84 women will take part in this study.
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
- 19 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female cancer survivors age 19-49
- •Cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
- •Diagnosed with first cancer ≥ age 18
- •No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned
- •Ability to read and write in English
- •Bothered by significant sexual dysfunction as evidenced by a Female Sexual Functioning Index (FSFI) score of ≤
- •Regular access to the internet
排除标准
- •Has never been sexually active
- •Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
研究组 & 干预措施
SHAREonline
Participants will receive:
- One online group session structured around three 60-minute modules and creation of a personal action plan
- Single Coaching phone call at one month
- Questionnaires to complete at baseline, 2 and 4 Months
干预措施: Group Session (Behavioral)
SHAREonline
Participants will receive:
- One online group session structured around three 60-minute modules and creation of a personal action plan
- Single Coaching phone call at one month
- Questionnaires to complete at baseline, 2 and 4 Months
干预措施: Coaching Call (Behavioral)
Individual Self Management
Brief individualized session with online and written materials and guidance.
All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention
干预措施: Educational Materials (Behavioral)
结局指标
主要结局
Change in Sexual Function
时间窗: Baseline to 2 months
The Female Sexual Function Index (FSFI Full Scale Score), is 19-item instrument which measures sexual function, including desire, orgasm, pain and satisfaction.
次要结局
- Study Engagement Rate(Baseline to 1 month)
- Intervention Completion Rate(Baseline to 4 months)
- Enrollment Rate(Baseline to 1 month)
- Change in Emotional Distress(Baseline to 4 months)
- Change in Sexual Function(Baseline to 4 months)
- Intervention Acceptability Rate(Up to 1 month-post intervention)
- Distress about Sexual Function(Baseline to 4 months)
- Sexual Function, Satisfaction and Sexual Inactivity(Baseline to 2 months)
- Distress about Sexual Function(Baseline to 2 months)
- Change in Emotional Distress(Baseline to 2 month)
研究者
Sharon Bober, Ph.D
Principal Investigator
Dana-Farber Cancer Institute