A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms (GO-EXCAP2)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Myeloid Neoplasm
• Intervention / Treatment: Behavioral: GO-EXCAP Mobile App; Behavioral: Behavioral Placebo Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kah Poh Loh; Phone Number: 585-275-5863; Email: kahpoh_loh@urmc.rochester.edu
• Study Contact Backup: Name: Becky Gravenstede; Phone Number: 585-727-4728; Email: becky_gravenstede@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center/Wilmot Cancer Institute
      • Contact: Kah Poh Loh, MBBCh BAO, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 (participants 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 subject's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GO-EXCAP; 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; A mobile app delivery platform to deliver an exercise program [Exercise for Cancer Patients (EXCAP©®)]. EXCAP©®) is a progressive walking and resistance exercise program
Active Comparator: Behavioral Placebo Control; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference between experimental and active comparator arms -Inflammatory cytokines	Inflammatory cytokines including TNFα, sTNFR1, sTNFR2, IL-1β, IL-2, IL-6, sIL-6R, IL-8, IL-10	12 Weeks
Difference between experimental and active comparator arms- DNA methylation in the TNFα promoter region	DNA methylation in the TNFα promoter region	12 Weeks
Difference between experimental and active comparator arms- TNFα gene expression	TNFα gene expression by PCR	12 Weeks

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kah Poh Loh, University of Rochester

Publications and helpful links

General Publications

• Loh KP, Sanapala C, Jensen-Battaglia M, Rana A, Sohn MB, Watson E, Gilmore N, Klepin HD, Mendler JH, Liesveld J, Huselton E, LoCastro M, Susiarjo M, Netherby-Winslow C, Williams AM, Mustian K, Vertino P, Janelsins MC. Exercise and epigenetic ages in older adults with myeloid malignancies. Eur J Med Res. 2023 May 30;28(1):180. doi: 10.1186/s40001-023-01145-z.
• Wang Y, Jensen-Battaglia M, Lin PJ, Kleckner I, Hayward E, Mendler J, Liesveld J, LoCastro M, Fallone Sharma C, Mortaz Hedjri S, Dunne R, Mustian K, Loh KP. Gait Changes After a Mobile Health Exercise Intervention in Older Adults With Myeloid Neoplasms: Single-Arm Pilot Trial. JMIR Cancer. 2026 Apr 29;12:e80909. doi: 10.2196/80909.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Myeloid Neoplasm; mobile health exercise intervention; GO-EXCAP
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: UCCS21043; R00CA237744 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A complete and final study protocol will be made publicly available through the University of Rochester Cancer Center Community Oncology Research Program Research Base Protocol and Data Sharing Committee. The full protocol and data will be made publicly available no later than the publication date of the study findings from the final dataset. The protocol will include a detailed description of the study population, hypotheses tested, measurement and assessment information, data definitions and codes, and the analysis plan utilized. We will also make this protocol available to NIH and NCI at the time of submission of each progress report and at the end of the final funding year. We will be collecting identifying information. The final dataset will be stripped of identifiers prior to release for sharing.Published papers will be made available in portable document format.
• IPD Sharing Time Frame: The data will be available for 7 years after study completion.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No