Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Feasibility of patient recruitment
研究概览
简要总结
This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants.
II. To determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population.
III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
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
- Single (Participant)
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
- •Patients with a new suspected or confirmed gynecologic malignancies
- •Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
- •Patients must be English speaking
排除标准
- •Previous treatment of any cancer excluding skin cancer
- •Patients with a suspected benign gynecologic process
- •Patients who are prisoners or incarcerated
结局指标
主要结局
Feasibility of patient recruitment
时间窗: Up to 9 months
To inform possible issues in recruitment for a large-scale randomized controlled trial, the ratio of enrolled subjects to total eligible potential subjects as well as the time necessary to recruit those subjects will be tracked.
次要结局
- Resumption of sexual activity after cancer surgery(Up to 9 months)
- Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire(Up to 9 months)
- Recall of intervention(Up to 9 months)
- Retention(Up to 9 months)
- PROMIS Sexual Function Profile(Up to 9 months)
- Patient-reported anxiety measured by PROMIS Anxiety 4a short form(Up to 6 months)
- Rate of referral acceptance(Up to 9 months)