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Recruiting NCT04981821

A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms

Trial Parameters

Condition Cancer
Sponsor University of Rochester
Study Type INTERVENTIONAL
Phase N/A
Enrollment 170
Sex ALL
Min Age 60 Years
Max Age N/A
Start Date 2022-01-03
Completion 2026-06-30
Interventions
GO-EXCAP Mobile AppBehavioral Placebo Control

Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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