Recruiting

Mobile Health Exercise

Sponsor:

University of Rochester

Code:

NCT04981821

Conditions

Cancer

Myeloid Neoplasm

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

GO-EXCAP Mobile App

Behavioral Placebo Control

Study Details

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.

Conditions

Cancer

Myeloid Neoplasm

Study ID

NCT04981821

Start date

Jan 3, 2022

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

GO-EXCAP Mobile App

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

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 and Locations

Central contacts

Kah Poh Loh

585-275-5863kahpoh_loh@urmc.rochester.edu

Becky Gravenstede

585-727-4728becky_gravenstede@urmc.rochester.edu

Locations

University of Rochester Medical Center/Wilmot Cancer Institute

Recruiting

Rochester, New York, United States, 14642

More Information

Sponsor

University of Rochester

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • mobile health exercise intervention
  • Myeloid Neoplasm
  • GO-EXCAP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-07-15.