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

Part of paid clinical trials in Rochester, New York.

Sponsor
University of Rochester
Study ID
NCT04981821
Status
Recruiting
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Conditions

  • Cancer
  • Myeloid Neoplasm

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GO-EXCAP Mobile App — BEHAVIORAL
    A mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program
  • Behavioral Placebo Control — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 3, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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
  • Active Comparator: 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.

Primary Outcome Measure

Difference between experimental and active comparator arms- Physical Function [ Time Frame: 12 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical Center/Wilmot Cancer InstituteRochesterNew York14642
Kah Poh Loh, MBBCh BAO, MS

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By research site
University of Rochester Medical Center/Wilmot Cancer Institute· Rochester, NY

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