Study to Remotely Monitor Activity in Transgender Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Remote Activity Assessment and PRO Collection
研究概览
简要总结
Prospective observational feasibility study to evaluate the role of wearable activity monitors to determine the feasibility and acceptability of remote monitoring using wearable technology and PROs to monitor fatigue and physical function in transgender cancer patients and survivors.
详细描述
Transgender cancer survivors are a diverse population who currently suffer from cancer-related disparities. Enrolled subjects will receive wearable activity devices to help understand how their daily activity (e.g., daily step counts, stairs climbed) and sleep levels are affected by their symptoms and treatment side-effects, including fatigue, physical functioning, emotional well-being, sleep quality, and quality of life over the 2-week course of the study. Qualitative interviews will be conducted to gain a deeper understanding of barriers to physical activity and their perceived relationships with their cancer history, treatment symptoms and gender affirming hormone therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identifies as transgender person with a history of cancer or receiving treatment for cancer in the last five years from screening for the current study (case) OR self-identifies as transgender person without a history of cancer (control)
- •18 years or older
- •Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
- •Access to a device (e.g., smartphone, tablet, iPhone) that has the capability to sync to the Fitbit
- •Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
- •Can read and understand English, Spanish, or Tagalog (for participant surveys and interviews)
- •Informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Any person that does not meet the listed criteria above
- •Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment*. However, removable hearing aids are permitted.
结局指标
主要结局
Feasibility of Remote Activity Assessment and PRO Collection
时间窗: 2 weeks
Proportion of patients who consent to participate in the research study and complete the baseline fatigue assessment, where a proportion of 50% will be considered feasible.
次要结局
- Patient-reported mood(up to 2 weeks)
- Average daily step count (steps/day)(2 weeks)
- 24-Hour Movement(2 weeks)
- Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity(2 weeks)
- Patient-reported health and well-being(2 weeks)
研究者
Gillian Gresham
Assistant Professor
Cedars-Sinai Medical Center