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

Not Applicable

Recruiting

• Conditions: Cancer; Myeloid Neoplasm
• Interventions: Behavioral: Behavioral Placebo Control; Behavioral: GO-EXCAP Mobile App

• Registration Number: NCT04981821
• Lead Sponsor: University of Rochester

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-07-29
• Study Start: 2022-01-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-03
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Placebo Control	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.
GO-EXCAP	GO-EXCAP Mobile App	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

Primary Outcome Measures

Name	Time	Method
Difference between experimental and active comparator arms- Physical Function	12 Weeks	Changes in physical function measured using the Short Physical Performance Battery (SPPB) which an objective physical assessment evaluating lower extremity physical function (score ranges from 0-12; higher score indicates better physical function). It is comprised of 3 components: a four-meter walk, repeated chair stands and a balance test (the score for each component ranges from 0-4).

Secondary Outcome Measures

Name	Time	Method
Difference between experimental and active comparator arms -Depression	12 Weeks	Changes in depression measured using the Center for Epidemiological Studies Depression Scale (CES-D) which is a 20-item depression scale. The score for each item ranges from 0-3, a higher score indicates higher self-reported depression levels.
Difference between experimental and active comparator arms -Quality of Life	12 Weeks	Changes in quality of life measured using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) scale. It consists of 44 items divided into 5 subscales: physical well-being (PWB), social well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and leukemia-specific concerns. The score for each item ranges from 0-4. After reversing the scoring of negatively worded items, all the scores are summated. A higher score indicates better quality of life.
Difference between experimental and active comparator arms -Fatigue	12 Weeks	Changes in fatigue measures using the Brief Fatigue Inventory (BFI) which is a 9-item, patient-reported instrument. The score for each item ranges from 0-10, a higher score indicates higher self-reported levels of fatigue.

Trial Locations

Locations (1)

University of Rochester Medical Center/Wilmot Cancer Institute; 🇺🇸 Rochester, New York, United States