Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

NCT ID: NCT04969367

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2023-07-19

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.

Conditions

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Myelodysplastic Syndromes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Medical Device Usage and Evaluation

Intervention Type OTHER

Wear activity monitor (Fitbit)

Biospecimen Collection

Intervention Type PROCEDURE

Undergo collection of blood samples

Questionnaire Administration

Intervention Type OTHER

Complete questionnaires

Quality-of-Life Assessment

Intervention Type OTHER

Complete questionnaires

Interventions

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Medical Device Usage and Evaluation

Wear activity monitor (Fitbit)

Intervention Type OTHER

Biospecimen Collection

Undergo collection of blood samples

Intervention Type PROCEDURE

Questionnaire Administration

Complete questionnaires

Intervention Type OTHER

Quality-of-Life Assessment

Complete questionnaires

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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JT 16333

Identifier Type: OTHER

Identifier Source: secondary_id

21D.214

Identifier Type: -

Identifier Source: org_study_id

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