Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
2026年6月29日 更新者：NYU Langone Health
Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
This is a pilot randomized controlled trial of a sexual health communication skills training multimedia intervention (Starting the Conversation [STC] adapted for patients with prostate cancer [PCa]) to improve patients' ability to communicate with providers about their sexual health concerns during PCa care compared to a time and attention control arm.
研究概览
详细说明
The investigators will conduct a pilot RCT of STC adapted for PCa with 100 patients randomly assigned to the intervention or control arm in a 1:1 ratio.
Primary feasibility outcomes are clinical trial metrics and feasibility, acceptability, and appropriateness of STC.
Primary efficacy outcomes are self-efficacy for sexual health communication with providers and rates of sexual health communication with providers.
Secondary efficacy outcomes are sexual health outcomes (use of therapies for sexual dysfunction, sexual activity, and sexual satisfaction).
Measures of efficacy will be compared between the intervention and control groups.
研究类型
介入性
注册 (估计的)
100
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Natasha Gupta, MD
- 电话号码：646-501-2599
- 邮箱：Natasha.gupta@nyulangone.org
学习地点
-
-
New York
-
New York、New York、美国、10016
- NYU Langone Health
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adult male with PCa at least 18 years of age
- Speak English
- Reside in the U.S.
- Have internet/web access, and
- Report current bother due to sexual dysfunction
- Capacity and willingness to provide consent
- Have an appointment with a PCa provider at NYU Langone Health during the study accrual period
Exclusion Criteria:
- Individual with impaired decision-making capacity.
- Participation in another part of this study (prior aim)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Exposure to STC Intervention
Participants will receive a multimedia intervention focused on teaching communication skills to help patients with prostate cancer discuss their sexual health concerns with their healthcare providers.
|
20-minute slideshow, 5-page workbook, 2-page supportive care resource guide focused on sexual health and teaching communication skills to help patients with prostate cancer discuss their sexual health concerns with their healthcare providers.
|
|
有源比较器：Control Arm
The control arm will be exposed to a 2-page supportive care resource guide, as well as a video slideshow and pamphlet on diet, sleep, and exercise for patients with prostate cancer.
|
2-page supportive care resource guide, as well as a 20-minute video slideshow and 5-page pamphlet on diet, sleep, and exercise for patients with prostate cancer.
|
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 |
|---|---|---|
|
Eligibility rate
大体时间：Baseline
|
Proportion of screened individuals who are eligible
|
Baseline
|
|
Enrollment rate
大体时间：Baseline
|
Proportion of eligible individuals who enroll
|
Baseline
|
|
Retention rate
大体时间：Up to Month 2 Follow-Up
|
Proportion of enrolled participants who are not lost to follow-up
|
Up to Month 2 Follow-Up
|
|
Assessment process
大体时间：Up to Month 2 Follow-Up
|
Proportion of participants who completed intervention and assessments
|
Up to Month 2 Follow-Up
|
|
Feasibility of Intervention Measure (FIM)
大体时间：Post-Appointment (Day 1)
|
FIM is a validated 4-item scale designed to evaluate whether a specific intervention or practice can be successfully implemented and carried out within a given setting.
Each item is rated on a scale from 1-5; the total score is the average of the responses and ranges from 1-5; higher scores indicate greater feasibility.
|
Post-Appointment (Day 1)
|
|
Acceptability of Intervention Measure (AIM)
大体时间：Post-Appointment (Day 1)
|
AIM is a validated 4-item scale used in implementation research to assess stakeholders' perception that a new program, treatment, or practice is agreeable and satisfactory.
Each item is rated on a scale from 1-5; the total score is the average of the responses and ranges from 1-5; a higher overall average indicates a greater level of acceptability for the intervention.
|
Post-Appointment (Day 1)
|
|
Intervention Appropriateness Measure (IAM)
大体时间：Post-Appointment (Day 1)
|
The Intervention Appropriateness Measure (IAM) is a validated, 4-item tool used in implementation science to assess the perceived fit, relevance, and suitability of an intervention.
Each item is rated on scale from 1-5; the total score is the average of responses and ranges from 1-5; higher scores indicate greater appropriateness.
|
Post-Appointment (Day 1)
|
|
Number of patients who raised a sexual health topic during clinic visit
大体时间：Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
|
Number of patients who discussed sexual health concerns during clinic visit
大体时间：Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
|
Number of patients who asked a sexual health question during clinic visit
大体时间：Post-Appointment (Day 1)
|
Post-Appointment (Day 1)
|
|
|
Self Efficacy - Talking about Sexual Health
大体时间：Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
Self-efficacy for talking about sexual health with a healthcare provider, scored from 0-10.
Higher scores indicate greater self-efficacy.
|
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
|
Self Efficacy - Asking about Sexual Health
大体时间：Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
Self-efficacy for asking a healthcare provider about sexual health, scored from 0-10.
Higher scores indicate greater self-efficacy.
|
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PROMIS Sexual Function and Satisfaction Measure (PROMIS SexFS v2.0)
大体时间：Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
Questions from the domains of 1) engagement in sexual activity and 2) use of therapeutic aids for sexual activity will be converted into dichotomous variables; proportions will be evaluated at each time point as well as over time using a Z-test for differences in proportions between groups; higher scores indicate greater sexual function and satisfaction.
The domain of global satisfaction with sex life will be assessed as the change over time and compared between groups using two-sample t-tests.
|
Baseline, Post-Appointment (Day 1), Month 2 Follow-Up
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Natasha Gupta, MD、NYU Langone Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2028年10月31日
研究完成 (估计的)
2028年10月31日
研究注册日期
首次提交
2026年6月11日
首先提交符合 QC 标准的
2026年6月11日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 26-00587
- K08CA293275 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health.
Datasets that can be shared will be deposited in open ICPSR.
The protocol and statistical analysis plan will be posted on Clinicaltrials.gov
only as required by federal regulation or supporting awards and agreements.
IPD 共享时间框架
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD 共享访问标准
Datasets that can be shared will be deposited in open ICPSR.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.