Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).
研究概览
简要总结
This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.
详细描述
The purpose of this research is to study the effectiveness of an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning. This study consists of attending a group educational session followed by a one-on-one telephone counseling session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 Stage1-IV ovarian cancer
- •Prognosis of at least one year to live (as assessed by provider)
- •Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
- •English speaking
- •Signed informed consent
排除标准
- •History of pelvic radiation
- •Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)
结局指标
主要结局
Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).
时间窗: Baseline, 2 month Post Intervention, 6 Month Post Intervention
次要结局
- Change in sexual self-efficacy will be assessed by change on the Sexual Self-Efficacy Scale(Baseline, 2 Month Post Intervention, 6 Month Post Intervention)
- Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants(Baseline, 2 Month Post Intervention, 6 Month Post Intervention)
- Improvement in sexual knowledge will be assessed by change on the Sexual Knowledge after Ovarian Cancer questionnaire(Baseline, 2 Month Post Intervention, 6 Month Post Intervention)
- Change in psychological distress will be assessed by change on the BSI-18 (Brief Symptom Inventory)(Baseline, 2 Month Post Intervention, 6 Month Post Intervention)
研究者
Sharon Bober, Ph.D
Principal Investigator
Dana-Farber Cancer Institute