Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04969367
• Other study ID #: 21D.214
• Status: Withdrawn
• Start date: May 10, 2021
• Est. completion date: July 19, 2023

Study information

• Verified date: August 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Other:
• Medical Device Usage and Evaluation
Wear activity monitor (Fitbit)

Procedure:
• Biospecimen Collection
Undergo collection of blood samples

Other:
• Questionnaire Administration
Complete questionnaires
• Quality-of-Life Assessment
Complete questionnaires

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accrual rate	accrual rate will be measured by counting subjects	Up to 90 days
Primary	Acceptability	Acceptability will be measured by a short survey	Up to 90 days
Primary	compliance with device	compliance with device (80% of the 90-day intervention time)	Up to 90 days
Primary	retention rate	retention rate of subjects will be measured by counting at 90 days	Up to 90 days
Primary	Acceptability	Acceptability will be measured by an interview addressing participant satisfaction	Up to 90 days
Secondary	Daily step count	Daily step count	Up to 90 days
Secondary	Average daily resting heart rate	average daily resting heart rate	Up to 90 days
Secondary	Fact-An score (assessed twice a week),	Fact-An score (assessed twice a week),	Up to 90 days
Secondary	Hemoglobin level measured by CBC twice a week	Hemoglobin level measured by CBC twice a week	Up to 90 days