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

Study Overview
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Brief Summary
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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
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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 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.

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

Conditions
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Cancer, Myeloid Neoplasm

Intervention / Treatment
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* Behavioral: GO-EXCAP Mobile App
* Behavioral: Behavioral Placebo Control


Participation Criteria
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Eligibility Criteria
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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 (patients 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 patient's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GO-EXCAP<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 to deliver an exercise program [Exercise for Cancer Patients (EXCAP©®)]. EXCAP©®) is a progressive walking and resistance exercise program<br>|
| Active Comparator: Behavioral Placebo Control<br>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. | Behavioral: Behavioral Placebo Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between experimental and active comparator arms- Physical Function | 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). | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between experimental and active comparator arms -Fatigue | 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. | 12 Weeks | 
| Difference between experimental and active comparator arms -Depression | 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. | 12 Weeks | 
| Difference between experimental and active comparator arms -Quality of Life | 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. | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile health exercise intervention, Myeloid Neoplasm, GO-EXCAP