Development and Preliminary Evaluation of a Tailored mHealth App Designed to Improve Quality-of-Life Outcomes in Ethnically-Diverse Black Prostate Cancer Survivors (SAFE-CaPs)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 248
- 试验地点
- 6
- 主要终点
- Overall Quality of Life (QoL) assessment in Black men with prostate cancer
研究概览
简要总结
The goal of this clinical trial is to ensure that the mobile health application for Black patients with prostate cancer (either actively undergoing treatment or survivors) is usable and acceptable to patients, get feedback about how to improve the app and assess its usefulness in examining their quality of life.
详细描述
The purpose of this study is to test the effectiveness of a culturally appropriate and specific mobile app for ethnically diverse Black men with prostate cancer (either those actively undergoing treatment or survivors) to empower them to be active participants in their care. This app will provide 1) relevant information/education about prostate cancer-specific to Black men; 2) symptoms monitoring - allowing participants to report difficulties and prompting providers to respond to concerns; and 3) testimonials from other patients with shared experiences.
All participants will be asked to complete surveys online when they start and then again at 3, 6, 9, and 12 months. A subset of randomized participants will be provided access to this app, which they will be asked to use at home for 12 months. The app users will answer daily surveys about their symptoms and activities as well as weekly mood assessments for 3 months. At the end of the 12 months, interviews will be conducted to receive feedback regarding the app.
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
- •- Ethnically-diverse Black prostate cancer (CaP) survivors who are either native-born, Caribbean-born, or African-born, within the early phase of their CaP survivorship journey (defined as within the first five years after diagnosis).
排除标准
- •Men from other races.
- •Men who have never been diagnosed with CaP
- •Men who have the inability to speak English
- •Men who do not own a smartphone
- •Black CaP survivors who are over 5 years since the time of diagnosis
研究组 & 干预措施
Control group
Participants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors.
干预措施: Surveys for Quality of Life (Behavioral)
Intervention group
Participants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors, who are given access to the mHealth app for this study.
干预措施: Surveys for Quality of Life (Behavioral)
Intervention group
Participants in this arm will be eligible Black men who have prostate cancer and are either currently undergoing treatment or are cancer survivors, who are given access to the mHealth app for this study.
干预措施: Surveys and mHealth App access (Behavioral)
结局指标
主要结局
Overall Quality of Life (QoL) assessment in Black men with prostate cancer
时间窗: 12 months
The proportion of patients in the intervention arm reporting increased QoL using the Functional Assessment of Cancer Therapy - Prostate (FACT-P) survey. FACT-P has five subscales: 1. Physical Well-Being- Evaluate symptoms like pain and energy. 2. Social/Family Well-Being- Measures support and communication satisfaction. 3. Emotional Well-Being- Assesses sadness, anxiety, coping, and hope. 4. Functional Well-Being- Measures daily activities, contentment, and enjoyment. 5. Prostate Cancer Subscale- Addresses symptoms like sexual function, pain, and urinary issues. Higher scores indicating better QoL overall. FACT-P captures physical, social, emotional, functional, and prostate-specific well-being to measure comprehensive patient outcomes.
次要结局
未报告次要终点