A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Difference between experimental and active comparator arms- Physical Function
研究概览
简要总结
This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.
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 outpatient chemotherapy are understudied. The proposed study will investigate whether a novel mobile health exercise intervention that is adapted to this population 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
- Randomized
- 干预模型
- Parallel
- 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 ≥60 years (conventional definition of older age in clinical trials of MN)
- •Have a diagnosis of MN
- •Planned for or receiving outpatient cancer-directed treatments (participants receiving consolidative or maintenance outpatient therapies after induction chemotherapy are allowed to enroll)
- •English speaking
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
- •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
- •Physical, psychological, or social impairments that would interfere with subject's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team
研究组 & 干预措施
GO-EXCAP
GO-EXCAP Mobile App involves the use of a mobile app delivery platform to deliver an exercise program [Exercise for Cancer Patients (EXCAP©®)]. EXCAP©®) is a progressive walking and resistance exercise program
干预措施: GO-EXCAP Mobile App (Behavioral)
Behavioral Placebo Control
Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.
干预措施: Behavioral Placebo Control (Behavioral)
结局指标
主要结局
Difference between experimental and active comparator arms- Physical Function
时间窗: 12 Weeks
Changes in physical function measured using the Short Physical Performance Battery (SPPB) which an objective physical assessment evaluating lower extremity physical function (score ranges from 0-12; higher score indicates better physical function). It is comprised of 3 components: a four-meter walk, repeated chair stands and a balance test (the score for each component ranges from 0-4).
次要结局
- Difference between experimental and active comparator arms -Depression(12 Weeks)
- Difference between experimental and active comparator arms -Quality of Life(12 Weeks)
- Difference between experimental and active comparator arms -Fatigue(12 Weeks)
研究者
Kah Poh Loh
Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)
University of Rochester