A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms
A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
University of Rochester
170 participants
Jan 3, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- 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
Exclusion Criteria1
- 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
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Interventions
A mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04981821