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
2 other identifiers
interventional
170
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Jan 2022
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2021
CompletedFirst Posted
Study publicly available on registry
July 29, 2021
CompletedStudy Start
First participant enrolled
January 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 5, 2026
December 1, 2025
4.5 years
July 27, 2021
December 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Difference between experimental and active comparator arms -Fatigue
12 Weeks
Difference between experimental and active comparator arms -Depression
12 Weeks
Difference between experimental and active comparator arms -Quality of Life
12 Weeks
Other Outcomes (3)
Difference between experimental and active comparator arms -Inflammatory cytokines
12 Weeks
Difference between experimental and active comparator arms- DNA methylation in the TNFα promoter region
12 Weeks
Difference between experimental and active comparator arms- TNFα gene expression
12 Weeks
Study Arms (2)
GO-EXCAP
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
Behavioral Placebo Control
ACTIVE COMPARATORParticipants 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.
Interventions
A mobile app delivery platform to deliver an exercise program \[Exercise for Cancer Patients (EXCAP©®)\]. EXCAP©®) is a progressive walking and resistance exercise program
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
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/Wilmot Cancer Institute
Rochester, New York, 14642, United States
Related Publications (1)
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.
PMID: 37254221DERIVED
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Kah Poh Loh
University of Rochester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)
Study Record Dates
First Submitted
July 27, 2021
First Posted
July 29, 2021
Study Start
January 3, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 5, 2026
Record last verified: 2025-12
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.