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

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Completed

CT.gov ID

NCT03660228

Collaborator

Vera and Joseph Dresner Foundation (Other)

Enrollment

Location

Arm

32.4

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes	Other: Peri-Transfusion QOL Assessment	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Oct 17, 2018

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Jun 30, 2021

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

PTQA Utilization [Two months]
Assessed via follow-up survey at 2 months after index transfusion
Decisional regret [Two months]
Assessed via follow-up survey at 2 months after index transfusion
Perceptions of care [Two months]
Assessed via follow-up survey at 2 months after index transfusion
Perceived stress by the associated scales [Two months]
Assessed via follow-up survey at 2 months after index transfusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.