Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS

Study Overview
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Brief Summary
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This research study is evaluating how to best tailor blood transfusion decisions to match the quality of life changes experienced by individual patients with MDS.

Detailed Description
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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.

Official Title
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PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS

Conditions
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Myelodysplastic Syndromes

Intervention / Treatment
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* Other: Peri-Transfusion QOL Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peri-Transfusion QOL Assessment<br>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 | Other: Peri-Transfusion QOL Assessment<br>* Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of receipt of second transfusion (yes/no) (for those approaching first transfusion) | Assessed via medical record review at two months post index transfusion | Two months | 
| Number of units pRBCs (for those transfusion-dependent) | Assessed via medical record review at two months post index transfusion | Two months | 
| Number of hospitalizations (for both transfusion groups) | Assessed via medical record review at two months post index transfusion | Two months | 
| Number of clinic visits (for both transfusion groups) | Assessed via medical record review at two months post index transfusion | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTQA Utilization | Assessed via follow-up survey at 2 months after index transfusion | Two months | 
| Decisional regret | Assessed via follow-up survey at 2 months after index transfusion | Two months | 
| Perceptions of care | Assessed via follow-up survey at 2 months after index transfusion | Two months | 
| Perceived stress by the associated scales | Assessed via follow-up survey at 2 months after index transfusion | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDS, Myelodysplastic Syndromes, Quality of life, Tranfusion-dependent