Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

Thomas Jefferson University

Status: Withdrawn

Conditions: Myelodysplastic Syndromes

Treatments: Procedure: Biospecimen Collection; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Medical Device Usage and Evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT04969367

21D.214

JT 16333 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Observational (activity monitor)

Description:

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.

Treatment:

Other: Medical Device Usage and Evaluation

Other: Quality-of-Life Assessment

Other: Questionnaire Administration

Procedure: Biospecimen Collection