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

Myelodysplastic Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660228
• Other study ID #: 18-307
• Status: Completed
• Phase: N/A
• Start date: October 17, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

Intervention

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)

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Vera and Joseph Dresner Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Receipt of Second Transfusion	Assessed via medical record review at two months post index transfusion	Two months
Primary	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
Primary	Number of Hospitalizations (for Both Transfusion Groups)	Assessed via medical record review at two months post index transfusion	Two months
Primary	Number of Clinic Visits (for Both Transfusion Groups)	Assessed via medical record review at two months post index transfusion	Two months
Secondary	PTQA Utilization	Assessed via follow-up survey at 2 months after index transfusion	Two months
Secondary	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
Secondary	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
Secondary	Perceived Stress by the Associated Scales	Assessed via follow-up survey at 2 months after index transfusion	Two months