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

Dana-Farber Cancer Institute62 enrolled

Overview

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.

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

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndromes

Interventions

Peri-Transfusion QOL AssessmentOTHER

Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Number of Participants With Receipt of Second Transfusion

Assessed via medical record review at two months post index transfusion

Time frame: Two months

Median Difference in Units pRBCs (for Those Transfusion-dependent)

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.

Time frame: Two months

Number of Hospitalizations (for Both Transfusion Groups)

Assessed via medical record review at two months post index transfusion

Time frame: Two months

Number of Clinic Visits (for Both Transfusion Groups)

Assessed via medical record review at two months post index transfusion

Time frame: Two months

Secondary Outcomes

PTQA Utilization

Assessed via follow-up survey at 2 months after index transfusion

Time frame: Two months

Number of Patients With Decisional Regret

Assessed 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.

Time frame: Two months

Perceptions of Impact of PTQA on Care

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.

Data from ClinicalTrials.gov

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