Sexual Health and Rehabilitation for Women With Metastatic Breast Cancer (SHARE-MC): An Educational Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline
研究概览
简要总结
This trial will evaluate the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer.
详细描述
This is a Phase II proof-of-concept investigational study evaluating the SHARE-MC educational intervention designed to address sexual health needs and related adjustment in women with metastatic breast cancer. Participants will be randomized 2:1 to receive either a group education session, or an individual self-management session. the SHARE MC intervention or enhanced usual care.
The research study procedures include: screening for eligibility, questionnaires, video conference, educational session, and coaching (as applicable).
It is expected that about 96 women will take part in this study. About 64 women will receive the group education session and about 32 will receive the individual self-management session.
Participation in this research study is expected to last about 16 weeks.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with metastatic breast cancer
- •Functionally appropriate to participate in the intervention, as assessed by 3 functional assessment items from the EQ-5D (see Eligibility Screening, Appendix A)
- •Bothered by significant sexual dysfunction as evidenced by a Female Sexual Functioning Index (FSFI) score of ≤
- •(See Eligibility Screening, Appendix A)
- •Ability to read and write in English
- •Regular access to the internet
排除标准
- •Diagnosis of any cancer prior to age 18
- •Has never been sexually active
- •Prior participation in Dr. Bober's sexual health research studies or workshops; or previous appointments with Dr. Bober through the DFCI Sexual Health Program.
- •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
Group Education
64 participants will complete the following:
- Baseline visit
- 3-hour intervention session - educational modules
- 4-week coaching phone call
- 8- and 16-week follow-up assessment calls
- A subset of participants will complete qualitative interviews
干预措施: SHARE-MC (Behavioral)
Enhanced Usual Care (Individual Self-Management)
32 participants will complete the following:
- Baseline visit
- Individual videoconference session
- 4-week coaching phone call
- 8-week follow-up assessment call
- 8- and 16-week follow-up assessment calls
- Subset of participants will complete qualitative interviews
干预措施: Informational Booklet (Other)
结局指标
主要结局
Female Sexual Function Index (FSFI) Full-scale Score Change from Baseline
时间窗: Up to 8 weeks
The FSFI is a well-validated 19-item instrument assessing sexual function including lubrication, orgasm, pain and satisfaction. The total sexual function score is the sum of all domain scores, ranging from 2.0 (indicating not sexually active and no desire) to 36.0. A domain score of 0.0 means there was no sexual activity during the past month. Higher scores, both for individual domains and the total score, reflect better sexual functioning.
次要结局
- Brief Symptom Inventory (BSI-18) Score Change from Baseline(Up to 8 weeks)
研究者
Sharon Bober, Ph.D
Principal Investigator
Dana-Farber Cancer Institute