A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Rochester
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Difference between experimental and active comparator arms- Physical Function
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
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.
Investigators
Kah Poh Loh
Assistant Professor - Department of Medicine , Hematology/Oncology (SMD)
University of Rochester
Eligibility Criteria
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
Outcomes
Primary Outcomes
Difference between experimental and active comparator arms- Physical Function
Time Frame: 12 Weeks
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).
Secondary Outcomes
- Difference between experimental and active comparator arms -Depression(12 Weeks)
- Difference between experimental and active comparator arms -Quality of Life(12 Weeks)
- Difference between experimental and active comparator arms -Fatigue(12 Weeks)