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Completed

NCT Number: NCT03660228

Peri-Transfusion QOL Assessments (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peri-Transfusion QOL Assessment

Other

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

Primary outcomes

  1. Number of Participants With Receipt of Second Transfusion

    Time frame: Two months

    Assessed via medical record review at two months post index transfusion

  2. Median Difference in Units pRBCs (for Those Transfusion-dependent)

    Time frame: Two months

    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.

  3. Number of Hospitalizations (for Both Transfusion Groups)

    Time frame: Two months

    Assessed via medical record review at two months post index transfusion

  4. Number of Clinic Visits (for Both Transfusion Groups)

    Time frame: Two months

    Assessed via medical record review at two months post index transfusion

Secondary outcomes

  1. PTQA Utilization

    Time frame: Two months

    Assessed via follow-up survey at 2 months after index transfusion

  2. Number of Patients With Decisional Regret

    Time frame: Two months

    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.

  3. Perceptions of Impact of PTQA on Care

    Time frame: Two months

    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.

  4. Perceived Stress by the Associated Scales

    Time frame: Two months

    Assessed via follow-up survey at 2 months after index transfusion

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Vera and Joseph Dresner Foundation

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 6, 2018
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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