Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Measuring Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome (MDS)

Conditions
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Myelodysplastic Syndromes

Intervention / Treatment
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* Other: Medical Device Usage and Evaluation
* Procedure: Biospecimen Collection
* Other: Questionnaire Administration
* Other: Quality-of-Life Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed pathologic diagnosis of MDS Requiring >= 2 blood transfusions in the past month if previously diagnosed or hemoglobin =< 8 g/dL if newly diagnosed Age >= 18 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Ambulatory (use of a walking aid, such as a cane or rollator, is acceptable) Able to give informed consent Willing to comply with all study procedures and available for the duration of the study Able to read and/or understand English Have access to an iPhone 4S or later, iPad 3 generation or later, Android 5.0 or later, or Windows 10 device Have access to Bluetooth low energy (LE) and internet connection for syncing 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (activity monitor)<br>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. | Other: Medical Device Usage and Evaluation<br>* Wear activity monitor (Fitbit)<br>Procedure: Biospecimen Collection<br>* Undergo collection of blood samples<br>Other: Questionnaire Administration<br>* Complete questionnaires<br>Other: Quality-of-Life Assessment<br>* Complete questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |