NCT03660228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

October 17, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
3 years until next milestone

Results Posted

Study results publicly available

June 21, 2024

Completed
Last Updated

June 21, 2024

Status Verified

January 1, 2024

Enrollment Period

2.7 years

First QC Date

September 4, 2018

Results QC Date

March 10, 2022

Last Update Submit

January 5, 2024

Conditions

Myelodysplastic Syndromes

Keywords

MDSMyelodysplastic SyndromesQuality of lifeTranfusion-dependent

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With Receipt of Second Transfusion

    Assessed via medical record review at two months post index transfusion

    Two months

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

    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.

    Two months

  • Number of Hospitalizations (for Both Transfusion Groups)

    Assessed via medical record review at two months post index transfusion

    Two months

  • Number of Clinic Visits (for Both Transfusion Groups)

    Assessed via medical record review at two months post index transfusion

    Two months

Secondary Outcomes (4)

  • PTQA Utilization

    Two months

  • Number of Patients With Decisional Regret

    Two months

  • Perceptions of Impact of PTQA on Care

    Two months

  • Perceived Stress by the Associated Scales

    Two months

Study Arms (1)

Peri-Transfusion QOL Assessment

EXPERIMENTAL

* 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

Interventions

Peri-Transfusion QOL AssessmentOTHER

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

Peri-Transfusion QOL Assessment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Abel GA, Klepin HD, Magnavita ES, Jaung T, Lu W, Shallis RM, Hantel A, Bahl NE, Dellinger-Johnson R, Winer ES, Zeidan AM. Peri-transfusion quality-of-life assessment for patients with myelodysplastic syndromes. Transfusion. 2021 Oct;61(10):2830-2836. doi: 10.1111/trf.16584. Epub 2021 Jul 12.

    PMID: 34251040RESULT

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Results Point of Contact

Title
Gregory A. Abel, MD
Organization
Dana-Farber Cancer Institute
GAABEL@PARTNERS.ORG
617-632-2304

Study Officials

  • Gregory A Abel, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

October 17, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

June 21, 2024

Results First Posted

June 21, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)