Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
研究概览
地位
详细说明
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.
ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.
ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Wisconsin
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Madison、Wisconsin、美国、53792
- University of Wisconsin, Madison
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous treatment of any cancer excluding skin cancer
- Patients with a suspected benign gynecologic process
- Patients who are prisoners or incarcerated
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Arm I (standard counseling)
Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
|
辅助研究
Given standard counseling
其他名称：
|
|
实验性的：Arm II (standard counseling, scripted intervention)
Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
|
辅助研究
Given standard counseling
其他名称：
Given scripted intervention
|
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实验性的：Arm III (standard counseling, scripted intervention)
Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.
|
辅助研究
Given standard counseling
其他名称：
Given scripted intervention
|
|
实验性的：Arm IV (standard counseling, scripted intervention)
Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
|
辅助研究
Given standard counseling
其他名称：
Given scripted intervention
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of patient recruitment
大体时间：Up to 9 months
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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.
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Up to 9 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Resumption of sexual activity after cancer surgery
大体时间：Up to 9 months
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Resumption of sexual activity after cancer surgery will be measured using items adapted from a previous national, multi-site study of sexual outcomes following an acute myocardial infarction.
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Up to 9 months
|
|
Retention
大体时间：Up to 9 months
|
The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.
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Up to 9 months
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Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire
大体时间：Up to 9 months
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Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
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Up to 9 months
|
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PROMIS Sexual Function Profile
大体时间：Up to 9 months
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Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
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Up to 9 months
|
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Recall of intervention
大体时间：Up to 9 months
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Subjects will be queried to learn whether they recall receiving physician counseling about sexual health outcomes after surgery with follow up questions regarding whether or not the patient has spoken with other healthcare providers about sexual concerns.
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Up to 9 months
|
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Patient-reported anxiety measured by PROMIS Anxiety 4a short form
大体时间：Up to 6 months
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Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
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Up to 6 months
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Rate of referral acceptance
大体时间：Up to 9 months
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The rate of acceptance of sexual health clinic referrals as well as rates of utilization of these referrals will be tracked using medical record abstraction.
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Up to 9 months
|
合作者和调查者
调查人员
- 首席研究员：David Kushner、University of Wisconsin, Madison
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- UW13080 (其他标识符：University of Wisconsin Carbone Cancer Center)
- P30CA014520 (美国 NIH 拨款/合同)
- A532820 (其他标识符：UW Madison)
- SMPH/OBSTET & GYNECOL/OBSTET (其他标识符：UW Madison)
- NCI-2014-00471 (注册表标识符：NCI Trial ID)
- 2014-0122 (其他标识符：Institutional Review Board)
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