Study of Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes
A Multi-Center, Phase II Cross-sectional Study Investigating Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes: a Companion Study to the CIBMTR 10-CMSMDS-1-Approved Expanded Access Study
1 other identifier
observational
92
1 country
6
Brief Summary
This is a multi-center, Phase II, cross-sectional study comparing quality of life (QOL) as assessed by patient-reported outcomes (PROs) in older (≥65 years) adults vs younger (55-64 years) undergoing allogeneic hematopoietic cell transplantation (HCT) for myelodysplastic syndromes (MDS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2018
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedStudy Start
First participant enrolled
July 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2019
CompletedDecember 2, 2020
November 1, 2020
1.3 years
April 10, 2018
November 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old.
The primary objective is to compare the change in long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old as measured by the assessment and when the assessment occurred at a post-HCT timepoint.
Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
Secondary Outcomes (3)
Domain-specific QOL scores by age group as assessed by PROMIS measures.
6 months-1 year post-HCT, 1 year - 3 years post-HCT, 3 years+ post-HCT
To explore the feasibility of electronic PROs (ePRO) collection in recipients ≥65 years old and to compare their compliance to that in recipients 55-64, by evaluating completion rate of the assessment by subjects by age group.
Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
To identify factors associated with poor compliance with reporting one-time single time ePRO measures in both age groups, by categorizing and quantifying reasons why subjects chose not to participate.
Those completing the assessment at one timepoint 6 months-1 year post-HCT, Those completing the assessment at one timepoint 1 year - 3 years post-HCT, Those completing the assessment at one timepoint Greater than 3 years post-HCT
Study Arms (2)
Patients between 55-64 years of age
Patients between 55-64 years who have had a transplant at the following time points: * 6 months to 1 year ago * 1 year to 3 years ago * 3 years ago or more
Patients 65+ years of age
Patients 65+ years of age who have had a transplant at the following time points: * 6 months to 1 year ago * 1 year to 3 years ago * 3 years ago or more
Interventions
An electronic patient reported outcomes survey will be completed by the patient.
Eligibility Criteria
All subjects previously enrolled on the 10-CMSMDS-1 protocol at participating centers will be assessed for eligibility into this protocol. Those meeting inclusion and exclusion criteria and consenting to participate will be enrolled.
You may qualify if:
- In order to be eligible to participate on this study, an individual must meet all of the following criteria:
- Underwent an allogeneic HCT for MDS on the 10-CMSMDS-1 protocol
- Prior consent to research and future contact by the CIBMTR
- Ability to provide RCI BMT protocol 17-ePRO signed and dated informed consent form (ICF)
- Age ≥55 years at time of transplant
- Fluent in English or Spanish
- Greater than 6 months post-HCT
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation on this study.
- No access to an internet browser or email account
- Within 6 months of first HCT for MDS on the 10-CMSMDS-1 protocol
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Stanford University
Stanford, California, 94304, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bronwen E Shaw, MD, PhD
Center for International Blood and Marrow Transplant Research (CIBMTR)/Medical College of Wisconsin
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2018
First Posted
June 15, 2018
Study Start
July 23, 2018
Primary Completion
November 15, 2019
Study Completion
November 15, 2019
Last Updated
December 2, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share