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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-17

Study Completion Date

2021-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transfusion in Lower Risk MDS Patients: Predictors of Adequacy of Transfusion and Quality of Life in Lower Risk MDS

NCT06614595

Low Risk Myelodysplastic Syndromes

RECRUITING

Study Investigating Patient-Reported Outcomes in Lower-risk MDS Patients

NCT05582902

MDS MDS/MPN

RECRUITING

Home Blood Transfusions

NCT07121140

Hematologic Malignancy Myelodysplastic Syndromes Acute Myeloid Leukemia +1 more

RECRUITING NA

Comparison of Lower-risk MDS Patients With and Without Improvements in Fatigue Following Blood Transfusion Therapy

NCT04103359

Myelodysplatic Syndromes

TERMINATED NA

Cohort Study of New Prognostic Factors With Peripheral Blood and Bone Marrow Evaluation at the Time of Diagnosis and Relapse in Myelodysplastic Syndrome

NCT02330692

Myelodysplastic Syndrome

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelodysplastic Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Peri-Transfusion QOL Assessment

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peri-Transfusion QOL Assessment

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No