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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

Tracking Information
First Submitted Date  ICMJE September 4, 2018
First Posted Date  ICMJE September 6, 2018
Last Update Posted Date January 11, 2022
Actual Study Start Date  ICMJE October 17, 2018
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • 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
  • Number of units pRBCs (for those transfusion-dependent) [ Time Frame: Two months ]
    Assessed via medical record review at two months post index transfusion
  • Number of hospitalizations (for both transfusion groups) [ Time Frame: Two months ]
    Assessed via medical record review at two months post index transfusion
  • Number of clinic visits (for both transfusion groups) [ Time Frame: Two months ]
    Assessed via medical record review at two months post index transfusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • PTQA Utilization [ Time Frame: Two months ]
    Assessed via follow-up survey at 2 months after index transfusion
  • Decisional regret [ Time Frame: Two months ]
    Assessed via follow-up survey at 2 months after index transfusion
  • Perceptions of care [ Time Frame: Two months ]
    Assessed via follow-up survey at 2 months after index transfusion
  • Perceived stress by the associated scales [ Time Frame: Two months ]
    Assessed via follow-up survey at 2 months after index transfusion
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peri-Transfusion QOL Assessments (PTQA): A New Paradigm of Transfusion Decision Support for Patients With MDS
Official Title  ICMJE PTQA: A New Paradigm of Transfusion Decision Support for Patients With MDS
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Myelodysplastic Syndromes
Intervention  ICMJE 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)
Study Arms  ICMJE 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
Intervention: Other: Peri-Transfusion QOL Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2021)
62
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2018)
60
Actual Study Completion Date  ICMJE June 30, 2021
Actual Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03660228
Other Study ID Numbers  ICMJE 18-307
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gregory A. Abel, MD, Dana-Farber Cancer Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Dana-Farber Cancer Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Vera and Joseph Dresner Foundation
Investigators  ICMJE
Principal Investigator: Gregory A Abel, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP