Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Medical Device Usage and Evaluation

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Sidney Kimmel Cancer Center at Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Biospecimen Collection; Undergo collection of blood samples; Other: Questionnaire Administration; Complete questionnaires; Other: Quality-of-Life Assessment; Complete questionnaires; Other: Medical Device Usage and Evaluation; Wear activity monitor (Fitbit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Acceptability	Acceptability will be measured by an interview addressing participant satisfaction	Up to 90 days
Accrual rate	accrual rate will be measured by counting subjects	Up to 90 days
retention rate	retention rate of subjects will be measured by counting at 90 days	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

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 19, 2021
• First Posted (Actual): July 20, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: 21D.214

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No