N/A
Completed N=25
A Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms
Intervention
Source: ClinicalTrials.gov NCT04035499 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization — 18; 14 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Percentage of Patients Entering Any Exercise Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization |
18; 14 | — |
| PRIMARY Feasibility: Percentage of Patients Entering Resistance Data Into the Mobile App ≥50% of the Study Period Days, Excluding Hospitalization |
14 | — |
| PRIMARY Feasibility: Recruitment Rates |
38 | — |
| PRIMARY Feasibility: Retention Rates |
22 | — |
| SECONDARY Pre-post Changes in Short Physical Performance Battery (SPPB) |
9.0; 9.2; 0.2 | — |
| SECONDARY Pre-post Changes in Brief Fatigue Inventory (BFI) |
29.4; 23.2; -6.2 | — |
| SECONDARY Pre-post Changes in the Center for Epidemiological Studies Depression Scale (CES-D) |
11.7; 11.1; -0.6 | — |
| SECONDARY Pre-post Changes in Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) |
123.9; 127.1; 3.2 | — |
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)
Data sourced from ClinicalTrials.gov (NCT04035499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.