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

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

Recruiting
60 years and older
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

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 (patients 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 patient's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team

Study details
    Cancer
    Myeloid Neoplasm

NCT04981821

University of Rochester

15 April 2024

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