Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

NCT04969367 | Withdrawn

• 2 other identifiers: 21D.214JT 16333
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Daily step count

  Up to 90 days

• Average daily resting heart rate

  Up to 90 days

• Fact-An score (assessed twice a week),

  Up to 90 days

• Hemoglobin level measured by CBC twice a week

  Up to 90 days

Study Arms (1)

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.

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

Interventions

Medical Device Usage and Evaluation OTHER

Wear activity monitor (Fitbit)

Observational (activity monitor)

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Observational (activity monitor)

Questionnaire Administration OTHER

Complete questionnaires

Observational (activity monitor)

Quality-of-Life Assessment OTHER

Complete questionnaires

Observational (activity monitor)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with myelodysplastic syndrome (MDS) recruited from the Department of Medical Oncology- Jefferson Health

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: July 20, 2021
• Study Start: May 10, 2021
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)