Study of Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes

Center for International Blood and Marrow Transplant Research92 enrolled

Overview

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).

Transplant recipients who have met the inclusion and exclusion criteria and from participating study sites will be asked to complete an online consent and survey for the study. This survey is the patient-reported outcomes survey and will be used to assess quality of life. The survey results will then be compared by age group and by time post transplant, between 6 months and a year post transplant, 1 year to 3 years post transplant, and 3 years or more post transplant.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Myelodysplastic Syndromes Hematopoietic Cell Transplant

Interventions

ePRO surveyBEHAVIORAL

An electronic patient reported outcomes survey will be completed by the patient.

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: In order to be eligible to participate on this study, an individual must meet all of the following criteria: 1. Underwent an allogeneic HCT for MDS on the 10-CMSMDS-1 protocol 2. Prior consent to research and future contact by the CIBMTR 3. Ability to provide RCI BMT protocol 17-ePRO signed and dated informed consent form (ICF) 4. Age ≥55 years at time of transplant 5. Fluent in English or Spanish 6. Greater than 6 months post-HCT Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation on this study. 1. No access to an internet browser or email account 2. Within 6 months of first HCT for MDS on the 10-CMSMDS-1 protocol

Locations (6)

Stanford University

Stanford, California, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Domain-specific QOL scores by age group as assessed by PROMIS measures.

Time frame: 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.

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.

Data from ClinicalTrials.gov

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