Clinical trial NCT03660228: Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS
Official title: PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myelodysplastic Syndromes
Keywords: MDS
Myelodysplastic Syndromes
Quality of life
Tranfusion-dependent
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Vera and Joseph Dresner Foundation
First posted: 2018-09-06
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Receipt of Second Transfusion
timeFrame: Two months
measure: Median Difference in Units pRBCs (for Those Transfusion-dependent)
timeFrame: Two months
measure: Number of Hospitalizations (for Both Transfusion Groups)
timeFrame: Two months
measure: Number of Clinic Visits (for Both Transfusion Groups)
timeFrame: Two months
Secondary outcomes:
measure: PTQA Utilization
timeFrame: Two months
measure: Number of Patients With Decisional Regret
timeFrame: Two months
measure: Perceptions of Impact of PTQA on Care
timeFrame: Two months
measure: Perceived Stress by the Associated Scales
timeFrame: Two months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Gregory A Abel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger-Johnson R, Winer ES, Zeidan AM. Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes. Transfusion. 2021 Oct;61(10):2830-2836. doi: 10.1111/trf.16584. Epub 2021 Jul 12.