A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
GO-EXCAP
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedResults Posted
Study results publicly available
May 3, 2023
CompletedMarch 31, 2026
March 1, 2026
1.7 years
July 24, 2019
February 9, 2023
March 29, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
Pre-post Changes in Short Physical Performance Battery (SPPB)
Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Pre-post Changes in Brief Fatigue Inventory (BFI)
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)
8-12 weeks
Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
Baseline, Post-Intervention, Changes from baseline to post-intervention (an average of 8-12 weeks)
Study Arms (1)
Experimental Arm:single
EXPERIMENTALGO-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
Interventions
A mobile app delivery platform and the EXCAP©® exercise program
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Rochester Medical Center
Rochester, New York, 14642, United States
Related Publications (5)
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.
PMID: 31034591RESULTLoh 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.
PMID: 30373733RESULTJensen-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.
PMID: 39789445DERIVEDWang 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.
PMID: 37698745DERIVEDLoh 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.
PMID: 35320340DERIVED
Results Point of Contact
- Title
- Dr. Kah Poh Loh
- Organization
- University of Rochester Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Kah Poh Loh
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 29, 2019
Study Start
February 1, 2020
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
March 31, 2026
Results First Posted
May 3, 2023
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be available for 7 years after study completion.
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.