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

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

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.

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Other: Peri-Transfusion QOL Assessment

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Receipt of Second Transfusion	Assessed via medical record review at two months post index transfusion	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.	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
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.	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.	Two months
Perceived Stress by the Associated Scales	Assessed via follow-up survey at 2 months after index transfusion	Two months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Vera and Joseph Dresner Foundation
• Investigators: Principal Investigator: Gregory A Abel, MD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 6, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; MDS; Myelodysplastic Syndromes; Tranfusion-dependent
• Additional Relevant MeSH Terms: Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: 18-307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No