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| ID | Type | Description | Link |
|---|---|---|---|
| JT 16333 | Other Identifier | JeffTrial Number |
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Staffing
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This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.
This study assesses feasibility and patient acceptability of using a Fitbit to monitor step count and heart rate in transfusion dependent patients with myelodysplastic syndrome. Information from this study may help researchers understand if there is any correlation between activity level and anemia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (activity monitor) | Patients wear an activity monitor (Fitbit) for 90 days. Patients also undergo collection of blood samples and complete questionnaires twice weekly for up to 90 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medical Device Usage and Evaluation | Other | Wear activity monitor (Fitbit) |
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| Measure | Description | Time Frame |
|---|---|---|
| Accrual rate | accrual rate will be measured by counting subjects | Up to 90 days |
| Acceptability | Acceptability will be measured by a short survey | Up to 90 days |
| compliance with device | compliance with device (80% of the 90-day intervention time) | Up to 90 days |
| retention rate | retention rate of subjects will be measured by counting at 90 days | Up to 90 days |
| Acceptability | Acceptability will be measured by an interview addressing participant satisfaction | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily step count | Daily step count | Up to 90 days |
| Average daily resting heart rate | average daily resting heart rate | Up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
• Uncontrolled illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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Patients with myelodysplastic syndrome (MDS) recruited from the Department of Medical Oncology- Jefferson Health
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2021 | Aug 11, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Biospecimen Collection | Procedure | Undergo collection of blood samples |
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| Questionnaire Administration | Other | Complete questionnaires |
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| Quality-of-Life Assessment | Other | Complete questionnaires |
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| Fact-An score (assessed twice a week), | Fact-An score (assessed twice a week), | Up to 90 days |
| Hemoglobin level measured by CBC twice a week | Hemoglobin level measured by CBC twice a week | Up to 90 days |