A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms

University of Rochester25 enrolled

Overview

This is a pilot study to evaluate the feasibility of a mobile health exercise intervention (GO-EXCAP Mobile App) over 7 weeks in 25 patients with myeloid neoplasms receiving hypomethylating agents.

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 hypomethylating agents are understudied. The proposed study will evaluate a novel mobile health exercise intervention that is adapted to older patients with myeloid neoplasms receiving outpatient hypomethylating agents and investigate whether and how exercise can prevent physical function decline, improve fatigue and mood disturbances, and prevent worsening quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Intervention

Interventions

GO-EXCAP Mobile AppBEHAVIORAL

A mobile app delivery platform and the EXCAP©® exercise program

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age is greater than or equal to 60 years * Have a diagnosis of MN * Receiving outpatient chemotherapy (e.g., HMA) * English speaking * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * 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 Platelet count of 10,000 per microliter or less in the most recent blood draw (due to risk of spontaneous bleeding) prior to transfusion (i.e., patients are allowed to enroll if their platelet count is 10,000 per microliter or less but is scheduled to receive transfusion the day of consent)

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization

Percentage of patients entering any exercise data into the mobile app ≥50% of the study period days, excluding hospitalization

Time frame: 8-12 weeks

Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization

Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization

Time frame: 8-12 weeks

Feasibility: Recruitment Rates

Recruitment rates (percentage of patients who are approached and subsequently consent).

Time frame: Week 0, prior to baseline

Feasibility: Retention Rates

Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)

Time frame: 8-12 weeks

Secondary Outcomes

Pre-post Changes in Short Physical Performance Battery (SPPB)

Changes in physical function measured using the Short Physical Performance Battery (SPPB) which an objective physical assessment evaluating lower extremity physical function (total 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; scores are summed).

Time frame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)

Pre-post Changes in Brief Fatigue Inventory (BFI)

Data from ClinicalTrials.gov

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