A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intervention
- Sponsor
- University of Rochester
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Feasibility: Retention Rates
- Status
- Completed
- Last Updated
- 3 months ago
Overview
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.
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 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.
Investigators
Kah Poh Loh
Associate Professor - Department of Medicine, Hematology/Oncology (SMD)
University of Rochester
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Feasibility: Retention Rates
Time Frame: 8-12 weeks
Retention rates (percentage of patients who are enrolled i.e., complete baseline assessments and subsequently complete post-intervention assessments)
Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
Time Frame: 8-12 weeks
Percentage of patients entering any exercise data into the mobile app ≥50% of the study period days, excluding hospitalization
Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
Time Frame: 8-12 weeks
Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization
Feasibility: Recruitment Rates
Time Frame: Week 0, prior to baseline
Recruitment rates (percentage of patients who are approached and subsequently consent).
Secondary Outcomes
- 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 Short Physical Performance Battery (SPPB)(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))