Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS
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ClinicalTrials.gov Identifier: NCT03660228 |
Recruitment Status :
Completed
First Posted : September 6, 2018
Last Update Posted : January 11, 2022
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Condition or disease | Intervention/treatment | Phase |
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Myelodysplastic Syndromes | Other: Peri-Transfusion QOL Assessment | Not Applicable |
Each patient with MDS reacts differently to blood transfusions; some will feel better after transfusion, while others may not. The main purpose of this survey study is to determine whether it is possible to use quality of life changes - as measured by a validated questionnaire - experienced by individual patients to help physicians and patients with MDS make decisions regarding future blood transfusions. This research is being done because the investigators hope to help doctors better understand the impact of blood transfusions on the quality of life of each patient.
The study uses a standardized MDS-specific quality of life questionnaire that participants will fill out before and after an upcoming transfusion. The investigators will compare the scores of these questionnaires and notify both the participant and provider if the participant has experienced any changes (positive or negative) in his/her quality of life before and after transfusion. The investigators' hope is that doctor-patient teams will use this quality of life information to determine whether the participant should continue receiving transfusions, decrease the frequency of transfusions, or stop receiving transfusions altogether if not needed.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS |
Actual Study Start Date : | October 17, 2018 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
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Experimental: Peri-Transfusion QOL Assessment
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Other: Peri-Transfusion QOL Assessment
Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS) |
- Rate of receipt of second transfusion (yes/no) (for those approaching first transfusion) [ Time Frame: Two months ]Assessed via medical record review at two months post index transfusion
- Number of units pRBCs (for those transfusion-dependent) [ Time Frame: Two months ]Assessed via medical record review at two months post index transfusion
- Number of hospitalizations (for both transfusion groups) [ Time Frame: Two months ]Assessed via medical record review at two months post index transfusion
- Number of clinic visits (for both transfusion groups) [ Time Frame: Two months ]Assessed via medical record review at two months post index transfusion
- PTQA Utilization [ Time Frame: Two months ]Assessed via follow-up survey at 2 months after index transfusion
- Decisional regret [ Time Frame: Two months ]Assessed via follow-up survey at 2 months after index transfusion
- Perceptions of care [ Time Frame: Two months ]Assessed via follow-up survey at 2 months after index transfusion
- Perceived stress by the associated scales [ Time Frame: Two months ]Assessed via follow-up survey at 2 months after index transfusion

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years of age
- Patients with MDS
- Patients approaching an Hb of 8.5 g/dL during enrollment period OR
- Patients with >1 transfusion scheduled during an 8-week period
- Ability to read and understand English
Exclusion Criteria:
- Age <18 years
- Cr > 2
- Known CHF
- Unstable Angina
- Hb level below 7.5 g/dL or above 8.5 g/dL
- No plan for future transfusion.
- Patient enrollment will happen after patient has consented and scheduled their first/next transfusion.
- Patient will not be enrolled if no future transfusions are scheduled.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660228
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Gregory A Abel, MD | Dana-Farber Cancer Institute |
Responsible Party: | Gregory A. Abel, MD, Principal Investigator, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT03660228 |
Other Study ID Numbers: |
18-307 |
First Posted: | September 6, 2018 Key Record Dates |
Last Update Posted: | January 11, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
MDS Myelodysplastic Syndromes Quality of life Tranfusion-dependent |
Preleukemia Myelodysplastic Syndromes Bone Marrow Diseases |
Hematologic Diseases Precancerous Conditions Neoplasms |