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Completed

NCT Number: NCT04035499

A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms

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.

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Key information

Conditions

Intervention

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

GO-EXCAP Mobile App

Behavioral

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

Primary outcomes

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

    Time frame: 8-12 weeks

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

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

    Time frame: 8-12 weeks

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

  3. Feasibility: Recruitment Rates

    Time frame: Week 0, prior to baseline

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

  4. Feasibility: Retention Rates

    Time frame: 8-12 weeks

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

Secondary outcomes

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

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

    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).

  2. Pre-post Changes in Brief Fatigue Inventory (BFI)

    Time frame: Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 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 (scores are summed; total score ranges from 0-90), a higher score indicates higher self-reported levels of fatigue.

  3. Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D)

    Time frame: 8-12 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 (scores are summed; total score ranges from 0-60), a higher score indicates higher self-reported depression levels.

  4. Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)

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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: GO-EXCAP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 29, 2019
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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