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Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04969367
Collaborator
(none)
21
Enrollment
1
Location
30.7
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Medical Device Usage and Evaluation
  • Procedure: Biospecimen Collection
  • Other: Questionnaire Administration
  • Other: Quality-of-Life Assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
21 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Measuring Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome (MDS)
Actual Study Start Date :
May 10, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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.

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

Procedure: Biospecimen Collection
Undergo collection of blood samples

Other: Questionnaire Administration
Complete questionnaires

Other: Quality-of-Life Assessment
Complete questionnaires

Outcome Measures

Primary Outcome Measures

  1. Accrual rate [Up to 90 days]

    accrual rate

  2. Acceptability [Up to 90 days]

    Acceptability will be measured by a short survey

  3. compliance with device [Up to 90 days]

    compliance with device (80% of the 90-day intervention time)

  4. retention rate [Up to 90 days]

    retention rate

  5. Acceptability [Up to 90 days]

    Acceptability will be measured by an interview addressing participant satisfaction

Secondary Outcome Measures

  1. Daily step count [Up to 90 days]

    Daily step count

  2. Average daily resting heart rate [Up to 90 days]

    average daily resting heart rate

  3. Fact-An score (assessed twice a week), [Up to 90 days]

    Fact-An score (assessed twice a week),

  4. Hemoglobin level measured by CBC twice a week [Up to 90 days]

    Hemoglobin level measured by CBC twice a week

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Thomas Jefferson University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT04969367
Other Study ID Numbers:
  • 21D.214
First Posted:
Jul 20, 2021
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Preleukemia
Myelodysplastic Syndromes
Syndrome

Study Results

No Results Posted as of Aug 19, 2022