A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility: Retention Rates
研究概览
简要总结
This is a pilot study to evaluate the feasibility of a mobile health exercise intervention (GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid neoplasms receiving hypomethylating agents.
详细描述
Up to 98% of older patients with myeloid neoplasms experience physical function decline, fatigue, and mood disturbances. Mobile health exercise interventions are promising strategy to prevent physical function decline and improve fatigue and mood disturbances, but older patients with myeloid neoplasms receiving hypomethylating agents are understudied. The proposed study will evaluate a novel mobile health exercise intervention that is adapted to older patients with myeloid neoplasms receiving outpatient hypomethylating agents and investigate whether and how exercise can prevent physical function decline, improve fatigue and mood disturbances, and prevent worsening quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is greater than or equal to 60 years
- •Have a diagnosis of MN
- •Receiving outpatient chemotherapy (e.g., HMA)
- •English speaking
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •No medical contraindications for exercise per oncologist
- •Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without assistive device)
- •Able to provide informed consent
排除标准
- •Platelet count of 10,000 per microliter or less in the most recent blood draw (due to risk of spontaneous bleeding) prior to transfusion (i.e., patients are allowed to enroll if their platelet count is 10,000 per microliter or less but is scheduled to receive transfusion the day of consent)
结局指标
主要结局
Feasibility: Retention Rates
时间窗: 8-12 weeks
Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)
Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
时间窗: 8-12 weeks
Percentage of patients entering any exercise data into the mobile app ≥50% of the study period days, excluding hospitalization
Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
时间窗: 8-12 weeks
Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
Feasibility: Recruitment Rates
时间窗: Week 0, prior to baseline
Recruitment rates (percentage of patients who are approached and subsequently consent).
次要结局
- Pre-post Changes in Brief Fatigue Inventory (BFI)(Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks))
- Pre-post Changes in Short Physical Performance Battery (SPPB)(Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks))
- Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D)(8-12 weeks)
- Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)(Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks))
研究者
Kah Poh Loh
Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
University of Rochester