A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms (GO- EXCAP) Mobile App

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms

Conditions
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Intervention

Intervention / Treatment
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* Behavioral: GO-EXCAP Mobile App


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Evaluating the feasibility of a mobile health exercise intervention in older adults with myeloid neoplasms
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm:single<br>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 | Behavioral: GO-EXCAP Mobile App<br>* A mobile app delivery platform and the EXCAP©® exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 8-12 weeks | 
| Feasibility: Recruitment Rates | Recruitment rates (percentage of patients who are approached and subsequently consent). | 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) | 8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks) | 
| Pre-post Changes in Brief Fatigue Inventory (BFI) | 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 (scores are summed; total score ranges from 0-90), a higher score indicates higher self-reported levels of fatigue. | Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks) | 
| Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D) | 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 (scores are summed; total score ranges from 0-60), a higher score indicates higher self-reported depression levels. | 8-12 weeks | 
| Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) | 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 (total score ranges from 0-176). After reversing the scoring of negatively worded items, all the scores are summated. A higher score indicates better quality of life. | Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks) |