Pilot Randomized Controlled Trial of a Digital Intervention to Promote Wellness, Empowerment, and Lifestyle Learning for Patients With Myeloproliferative Neoplasms (WELL-MPN)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Number of patients consented and enrolled onto the study, and number of patients who complete at least 2 out of 3 modules in the app.
研究概览
简要总结
The goal of this clinical trial is to learn whether a digital lifestyle app can help improve diet, physical activity, symptoms, emotional well-being, and quality of life in adults with myeloproliferative neoplasms (MPNs).
The main questions it aims to answer are:
Can people with MPNs use the WELL-MPN app?
Does using the WELL-MPN app improve diet quality and physical activity?
Does the WELL-MPN app improve MPN-related symptoms, anxiety and depression, confidence in managing health, and overall quality of life?
Researchers will compare participants who use the WELL-MPN digital app with participants who receive written educational materials about diet and physical activity for people with cancer to see if the app leads to greater improvements in lifestyle behaviors, symptoms, and well-being.
Participants will:
Be randomly assigned to use the WELL-MPN app or receive written lifestyle education materials
Use the assigned program or materials over the study period
Complete surveys about diet, physical activity, symptoms, mood, confidence in self-care, and quality of life
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a myeloproliferative neoplasm (MPN) by World Health Organization 2016 criteria
- •Adult (age >/= 18)
- •Able to comprehend and speak English
- •Able to provide informed consent
排除标准
- •Unable to comprehend and speak English
- •Unable to provide informed consent
研究组 & 干预措施
WELL-MPN Digital App
WELL-MPN app and usual care
干预措施: WELL-MPN Digital App (Behavioral)
Enhanced Usual Care
Usual care and written literature about diet and physical activity guidelines in patients with cancer
结局指标
主要结局
Number of patients consented and enrolled onto the study, and number of patients who complete at least 2 out of 3 modules in the app.
时间窗: 2 years
Primary outcome is feasibility, defined as ≥60% enrollment of eligible patients and ≥70% of patients randomized to the intervention group completing at least 2 out of 3 of app modules.
8-Item Client Satisfaction Scores (CSQ-8)
时间窗: Enrollment to 16 weeks after enrollment
Acceptability of WELL-MPN as measured by CSQ-8 scores of WELL-MPN. The CSQ-8 is a self-report tool designed to measure patient satisfaction with a received intervention. It consists of 8 items rated on a 4-point Likert scale (from "quite dissatisfied" to "very satisfied"), with higher scores indicating greater satisfaction. WELL-MPN is considered acceptable if \>80% of participants on the WELL-MPN arm report a CSQ-8 score \>20.
次要结局
- Healthy Eating Index calculated from the Automated Self-Administered Dietary Assessment Tool(Enrollment to 16 weeks after enrollment.)
- Mini Eating Assessment Tool (Mini-EAT) score(Enrollment to 16 weeks after enrollment.)
- Godin Leisure Time Exercise Questionnaire(Enrollment to 16 weeks after enrollment.)
- Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Short Forms(Enrollment to 16 weeks after enrollment.)
- MPN Symptom Assessment Form (SAF) Total Symptom Score (TSS)(Enrollment to 16 weeks after enrollment.)
- Hospital Anxiety and Depression Scale (HADS-A and HADS-D):(Enrollment to 16 weeks after enrollment.)
- Functional Assessment of Cancer - General (FACT-G)(Enrollment to 16 weeks after enrollment.)
研究者
Chi-Joan How, MD
Principal Investigator
Brigham and Women's Hospital