Pilot Testing a Sexual Health Communication Skills Training Intervention for Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Individual with impaired decision-making capacity.
- •Participation in another part of this study (prior aim)
研究组 & 干预措施
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.
干预措施: Starting the Conversation (STC) (Behavioral)
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.
干预措施: Time and Attention (Behavioral)