Myelodysplastic SyndromesNCT04969367
Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome
An observational study of Myelodysplastic Syndromes, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Medical Device Usage and Evaluation, Biospecimen Collection and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 19 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with myelodysplastic syndrome (MDS) recruited from the Department of Medical Oncology- Jefferson Health
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: 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.
Read the 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.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Medical Device Usage and Evaluation, Biospecimen Collection, Questionnaire Administration, Quality-of-Life Assessment
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Device Usage and EvaluationOther
Wear activity monitor (Fitbit)
Biospecimen CollectionProcedure or surgery
Undergo collection of blood samples
Questionnaire AdministrationOther
Complete questionnaires
Quality-of-Life AssessmentOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medical Device Usage and Evaluation; Procedure: Biospecimen Collection; Other: Questionnaire Administration; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual rate
accrual rate will be measured by counting subjects
Measured: Up to 90 days
Acceptability
Acceptability will be measured by a short survey
Measured: Up to 90 days
compliance with device
compliance with device (80% of the 90-day intervention time)
Measured: Up to 90 days
retention rate
retention rate of subjects will be measured by counting at 90 days
Measured: Up to 90 days
Acceptability
Acceptability will be measured by an interview addressing participant satisfaction
Measured: Up to 90 days
Secondary outcomes (4)
Daily step count
Daily step count
Measured: Up to 90 days
Average daily resting heart rate
average daily resting heart rate
Measured: Up to 90 days
Fact-An score (assessed twice a week),
Fact-An score (assessed twice a week),
Measured: Up to 90 days
Hemoglobin level measured by CBC twice a week
Hemoglobin level measured by CBC twice a week
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start10 May 2021
- Primary completion19 Jul 2023
- Study completion19 Jul 2023
Why it stopped: Staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969367
- Sponsor's protocol ID
- 21D.214
- Other IDs
- JT 16333
- Status last verified
- Apr 2025
- First submitted
- 6 Jul 2021
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Physical Activity in Transfusion Dependent Patients With Myelodysplastic Syndrome (MDS)
- ClinicalTrials.gov ID
- NCT04969367
- Acronym / sponsor ID
- 21D.214
- Conditions
- Myelodysplastic Syndromes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Staffing
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 19 Jul 2023 (actual)
- Study completion
- 19 Jul 2023 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (activity monitor) | – | Other: Medical Device Usage and Evaluation, Procedure: Biospecimen Collection, Other: Questionnaire Administration, Other: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with myelodysplastic syndrome (MDS) recruited from the Department of Medical Oncology- Jefferson Health
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical Device Usage and EvaluationWear activity monitor (Fitbit) | Other | Observational (activity monitor) |
| Biospecimen CollectionUndergo collection of blood samples | Procedure or surgery | Observational (activity monitor) |
| Questionnaire AdministrationComplete questionnaires | Other | Observational (activity monitor) |
| Quality-of-Life AssessmentComplete questionnaires | Other | Observational (activity monitor) |
Primary outcome
Accrual rate
Time frame: Up to 90 days
accrual rate will be measured by counting subjects
Acceptability
Time frame: Up to 90 days
Acceptability will be measured by a short survey
compliance with device
Time frame: Up to 90 days
compliance with device (80% of the 90-day intervention time)
retention rate
Time frame: Up to 90 days
retention rate of subjects will be measured by counting at 90 days
Acceptability
Time frame: Up to 90 days
Acceptability will be measured by an interview addressing participant satisfaction
4 secondary outcomes
Daily step count
Time frame: Up to 90 days
Average daily resting heart rate
Time frame: Up to 90 days
Fact-An score (assessed twice a week),
Time frame: Up to 90 days
Hemoglobin level measured by CBC twice a week
Time frame: Up to 90 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual rate (time frame: Up to 90 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.