Mobile Health App to Mitigate the Metabolic Effects of Androgen Deprivation Therapy: A Randomize Pilot Trial in Men Newly Treated With Androgen Deprivation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Accumulation of body fat mass
研究概览
简要总结
This research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits.
详细描述
This research study seeks to develop and evaluate a mobile health app which aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habits. The first phase of the research study seeks to evaluate the experience of the first version of the mobile health app within a group of participants and what they think of it.
The investigators are interested in how individuals react to the use of a developed mobile health app and what they think of it.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All recruited participants must have owned a smartphone for >1 year
- •English-speaking.
- •Patients with prostate cancer aged between 40-75 years will be considered.
- •No specific timeframe after prostate cancer diagnosis will be required for these patients.
- •No limitations regarding their disease characteristics will be imposed (e.g. metastatic disease).
- •Patients may or may not be currently receiving treatment Staff members will be recruited from
- •Dana-Farber Cancer Institute Department of Medical Oncology,
- •Brigham and Women's Hospital, Department of Surgery. Staff members aged between 40-75 years old will be considered. Phase 2
- •Men diagnosed with prostate cancer presenting to DF/BWHCC
- •About to initiate ADT for the first time will be considered.
- •Age range 40-75-years
- •The ability to walk 400 m
- •Medical clearance from their primary physician
- •English speaking
- •Cognitively alert
- •Ability to read or hear with or without contacts/glass and hearing aid
- •Ownership of a smartphone for >1yr
排除标准
- •Men who have been under a rigorous structured exercise regime, such as individuals who engage in more than 900 minutes of moderate physical activity per week in the last 6 months will not be considered
- •Post-ADT treatment
- •Planned systemic chemotherapy
- •Planned treatment with abiraterone or enzalutamide
- •Bone metastases
- •Acute illness
- •Any musculoskeletal, cardiovascular, or neurologic disorders that could inhibit or put them at risk from exercising
- •Subordinates to the PI
结局指标
主要结局
Accumulation of body fat mass
时间窗: 2 years
This endpoint will be assessed with dual-energy x-ray absorptiometry - also known as a DEXA scan.
次要结局
- Percent fat(2 years)
- Estimated visceral adipose(2 years)
- Application's performance on iOS and Android platforms(2 years)
- Whole-body lean mass(2 years)
- Regional lean mass(2 years)
- Application's ability to effectively motivate and track outcomes for patients(2 years)
研究者
Quoc-Dien Trinh, MD
Principal Investigator
Dana-Farber Cancer Institute