Study of Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Behavioral: ePRO survey
An electronic patient reported outcomes survey will be completed by the patient.
|
| 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 |
Behavioral: ePRO survey
An electronic patient reported outcomes survey will be completed by the patient.
|
Outcome Measures
Primary Outcome Measures
- Long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old. [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]
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.
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
In order to be eligible to participate on this study, an individual must meet all of the following criteria:
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Underwent an allogeneic HCT for MDS on the 10-CMSMDS-1 protocol
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Prior consent to research and future contact by the CIBMTR
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Ability to provide RCI BMT protocol 17-ePRO signed and dated informed consent form (ICF)
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Age ≥55 years at time of transplant
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Fluent in English or Spanish
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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.
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No access to an internet browser or email account
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Within 6 months of first HCT for MDS on the 10-CMSMDS-1 protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Stanford | California | United States | 94304 |
| 2 | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 3 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
| 4 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 5 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 6 | Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | United States | 53226 |
Sponsors and Collaborators
- Center for International Blood and Marrow Transplant Research
- Medical College of Wisconsin
Investigators
- Principal Investigator: Bronwen E Shaw, MD, PhD, Center for International Blood and Marrow Transplant Research (CIBMTR)/Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-ePRO