A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms

NCT ID: NCT04035499

Last Updated: 2026-01-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-10-31

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.

Conditions

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Intervention

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Evaluating the feasibility of a mobile health exercise intervention in older adults with myeloid neoplasms
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental Arm:single

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

Group Type EXPERIMENTAL

GO-EXCAP Mobile App

Intervention Type BEHAVIORAL

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

Interventions

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GO-EXCAP Mobile App

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

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Kah Poh Loh

Associate Professor - Department of Medicine, Hematology/Oncology (SMD)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kah Poh Loh

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

References

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Loh KP, Kleckner IR, Lin PJ, Mohile SG, Canin BE, Flannery MA, Fung C, Dunne RF, Bautista J, Culakova E, Kleckner AS, Peppone LJ, Janelsins M, McHugh C, Conlin A, Cho JK, Kasbari S, Esparaz BT, Kuebler JP, Mustian KM. Effects of a Home-based Exercise Program on Anxiety and Mood Disturbances in Older Adults with Cancer Receiving Chemotherapy. J Am Geriatr Soc. 2019 May;67(5):1005-1011. doi: 10.1111/jgs.15951.

Reference Type RESULT
PMID: 31034591 (View on PubMed)

Loh KP, Ramsdale E, Culakova E, Mendler JH, Liesveld JL, O'Dwyer KM, McHugh C, Gilles M, Lloyd T, Goodman M, Klepin HD, Mustian KM, Schnall R, Mohile SG. Novel mHealth App to Deliver Geriatric Assessment-Driven Interventions for Older Adults With Cancer: Pilot Feasibility and Usability Study. JMIR Cancer. 2018 Oct 29;4(2):e10296. doi: 10.2196/10296.

Reference Type RESULT
PMID: 30373733 (View on PubMed)

Jensen-Battaglia M, Lin PJ, Sanapala C, Watson EE, Mendler JH, Liesveld J, Wang Y, Hayward E, LoCastro M, Mortaz S, Dunne RF, Mustian K, Loh KP. Changes in muscle performance among older adults with myeloid malignancies engaging in a mobile health (mHealth) exercise intervention: a single arm pilot study. BMC Geriatr. 2025 Jan 9;25(1):22. doi: 10.1186/s12877-024-05668-w.

Reference Type DERIVED
PMID: 39789445 (View on PubMed)

Wang K, Consagra W, Jensen-Battaglia M, Kleckner A, Kleckner IR, Loh KP. Chemotherapy-related symptoms and exercise adherence in older patients with myeloid neoplasms. Support Care Cancer. 2023 Sep 12;31(10):572. doi: 10.1007/s00520-023-08039-0.

Reference Type DERIVED
PMID: 37698745 (View on PubMed)

Loh KP, Sanapala C, Watson EE, Jensen-Battaglia M, Janelsins MC, Klepin HD, Schnall R, Culakova E, Vertino P, Susiarjo M, Lin PJ, Mendler JH, Liesveld JL, Huselton EJ, Taberner K, Mohile SG, Mustian K. A single-arm pilot study of a mobile health exercise intervention (GO-EXCAP) in older patients with myeloid neoplasms. Blood Adv. 2022 Jul 12;6(13):3850-3860. doi: 10.1182/bloodadvances.2022007056.

Reference Type DERIVED
PMID: 35320340 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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UCCS19090

Identifier Type: -

Identifier Source: org_study_id

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