Promoting Effective Clinical Communication About Sexual Health After Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Clinical Communication - Express a Concern about Sexual Health
研究概览
简要总结
The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.
The main questions it aims to answer are:
- Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone?
- Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone?
Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care.
Participants will:
- Fill out a consent form and survey
- Have their next clinic visit audio recorded
- Fill out another survey right after their clinic visit
- Fill out a final survey 6 months after their clinic visit
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
- Double (Care Provider, Outcomes Assessor)
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
- •At least 18 years old
- •Diagnosed with any stage (I-IV) gynecologic cancer
- •Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago
- •Attending visits in follow-up care at Fox Chase Cancer Center
- •Score of at least 3 on a sexual concerns screener question
排除标准
- •Not able to speak English
- •Not willing to have clinic visit audio recorded
- •Eastern Cooperative Oncology Group (ECOG) score > 2
- •Overt cognitive dysfunction or psychiatric disturbance
研究组 & 干预措施
Sexual Health Resources + Starting the Conversation Video/Workbook
Participants will receive a resource guide on sexual health and gynecologic cancer and will be asked to watch a 25-minute video with information about sexual health and gynecologic cancer and learn ways to talk to their cancer care provider effectively about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills and plan their discussion.
干预措施: Starting the Conversation (Behavioral)
Sexual Health Resources + Starting the Conversation Video/Workbook
Participants will receive a resource guide on sexual health and gynecologic cancer and will be asked to watch a 25-minute video with information about sexual health and gynecologic cancer and learn ways to talk to their cancer care provider effectively about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills and plan their discussion.
干预措施: Sexual Health Resources (Behavioral)
结局指标
主要结局
Clinical Communication - Express a Concern about Sexual Health
时间窗: 2 weeks
Number of patients who express a sexual health concern in a clinic visit.
Clinical Communication - Raise Topic of Sexual Health
时间窗: 2 weeks
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Clinical Communication - Ask a Question about Sexual Health
时间窗: 2 weeks
Number of patients who ask a question about sexual health concerns in a clinic visit.
次要结局
- Self-Reported Sexual Function(Baseline, 2 weeks, 3 months, 6 months)
- Self-Reported Sexual Activity(Baseline, 2 weeks, 3 months, 6 months)
- Self-Reported Anxiety Symptoms(Baseline, 2 weeks, 3 months, 6 months)
- Self-Reported Depressive Symptoms(Baseline, 2 weeks, 3 months, 6 months)