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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Myelodysplastic Syndromes, Hematopoietic Cell Transplant

Intervention / Treatment
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* Behavioral: ePRO survey


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients between 55-64 years of age<br>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 | Behavioral: ePRO survey<br>* An electronic patient reported outcomes survey will be completed by the patient.<br>|
| Patients 65+ years of age<br>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 | Behavioral: ePRO survey<br>* An electronic patient reported outcomes survey will be completed by the patient.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |