Trial Outcomes & Findings for Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS (NCT NCT03660228)
NCT ID: NCT03660228
Last Updated: 2024-06-21
Results Overview
Assessed via medical record review at two months post index transfusion
COMPLETED
NA
62 participants
Two months
2024-06-21
Participant Flow
Participant milestones
| Measure |
Peri-Transfusion QOL Assessment
* Participants will be given a study packet containing a paper copy of the QUALMS
* Study participants will fill out the survey on the day before their first/next pRBC transfusion.
* Study participants will receive a second paper copy of the QUALMS, along with a stamped envelope addressed to the appropriate site
* The second assessment will be scored and compared with the first, and both the patient and provider will be sent a report with the results
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)
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|---|---|
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Overall Study
STARTED
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62
|
|
Overall Study
COMPLETED
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38
|
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Overall Study
NOT COMPLETED
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Peri-Transfusion QOL Assessment
n=38 Participants
* Participants will be given a study packet containing a paper copy of the QUALMS
* Study participants will fill out the survey on the day before their first/next pRBC transfusion.
* Study participants will receive a second paper copy of the QUALMS, along with a stamped envelope addressed to the appropriate site
* The second assessment will be scored and compared with the first, and both the patient and provider will be sent a report with the results
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)
|
|---|---|
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Age, Continuous
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73 years
STANDARD_DEVIATION 11.6 • n=38 Participants
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Sex: Female, Male
Female
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16 Participants
n=38 Participants
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Sex: Female, Male
Male
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22 Participants
n=38 Participants
|
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Transfusion-dependent
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34 Participants
n=38 Participants
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PRIMARY outcome
Timeframe: Two monthsPopulation: Data not collected.
Assessed via medical record review at two months post index transfusion
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two monthsPopulation: Data not collected.
Assessed via medical record review at two months post index transfusion. We identified historical matches for 25 patients (21 from Dana-Farber, 1 from Wake Forest, and 3 from Yale) and compared the median number of red cell units in these patients to the PTQA group over 2 months.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two monthsPopulation: Data not collected.
Assessed via medical record review at two months post index transfusion
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two monthsPopulation: Data not collected.
Assessed via medical record review at two months post index transfusion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two monthsPopulation: Data not collected.
Assessed via follow-up survey at 2 months after index transfusion
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two monthsAssessed via follow-up survey at 2 months after index transfusion. Of the 38 patients who completed PTQA, 6 did not complete the 2-month follow-up survey, and 1 passed away.
Outcome measures
| Measure |
Peri-Transfusion QOL Assessment
n=31 Participants
* Participants will be given a study packet containing a paper copy of the QUALMS
* Study participants will fill out the survey on the day before their first/next pRBC transfusion.
* Study participants will receive a second paper copy of the QUALMS, along with a stamped envelope addressed to the appropriate site
* The second assessment will be scored and compared with the first, and both the patient and provider will be sent a report with the results
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)
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|---|---|
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Number of Patients With Decisional Regret
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3 Participants
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SECONDARY outcome
Timeframe: Two monthsPopulation: Patients who underwent PTQA, were alive and were willing to complete the 2-month follow-up survey.
Percentage of patients reporting that PTQA impacted their treatment decisions. Assessed by a binary (yes/no) on the follow-up survey at 2-months after index transfusion.
Outcome measures
| Measure |
Peri-Transfusion QOL Assessment
n=31 Participants
* Participants will be given a study packet containing a paper copy of the QUALMS
* Study participants will fill out the survey on the day before their first/next pRBC transfusion.
* Study participants will receive a second paper copy of the QUALMS, along with a stamped envelope addressed to the appropriate site
* The second assessment will be scored and compared with the first, and both the patient and provider will be sent a report with the results
Peri-Transfusion QOL Assessment: Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)
|
|---|---|
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Perceptions of Impact of PTQA on Care
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24 Participants
|
SECONDARY outcome
Timeframe: Two monthsPopulation: Data not collected.
Assessed via follow-up survey at 2 months after index transfusion
Outcome measures
Outcome data not reported
Adverse Events
Peri-Transfusion QOL Assessment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place