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Trial record 1 of 1 for:    NCT03660228
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Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS

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ClinicalTrials.gov Identifier: NCT03660228
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : January 11, 2022
Sponsor:
Collaborator:
Vera and Joseph Dresner Foundation
Information provided by (Responsible Party):
Gregory A. Abel, MD, Dana-Farber Cancer Institute

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : October 17, 2018
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Rate of receipt of second transfusion (yes/no) (for those approaching first transfusion) [ Time Frame: Two months ]
    Assessed via medical record review at two months post index transfusion

  2. Number of units pRBCs (for those transfusion-dependent) [ Time Frame: Two months ]
    Assessed via medical record review at two months post index transfusion

  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 Outcome Measures :
  1. PTQA Utilization [ Time Frame: Two months ]
    Assessed via follow-up survey at 2 months after index transfusion

  2. Decisional regret [ Time Frame: Two months ]
    Assessed via follow-up survey at 2 months after index transfusion

  3. Perceptions of care [ Time Frame: Two months ]
    Assessed via 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660228


Locations
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United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Vera and Joseph Dresner Foundation
Investigators
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Principal Investigator: Gregory A Abel, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Gregory A. Abel, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03660228    
Other Study ID Numbers: 18-307
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gregory A. Abel, MD, Dana-Farber Cancer Institute:
MDS
Myelodysplastic Syndromes
Quality of life
Tranfusion-dependent
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Neoplasms