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| Name | Class |
|---|---|
| Medical College of Wisconsin | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients between 55-64 years of age | Patients between 55-64 years who have had a transplant at the following time points:
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| Patients 65+ years of age | Patients 65+ years of age who have had a transplant at the following time points:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePRO survey | Behavioral | An electronic patient reported outcomes survey will be completed by the patient. |
|
| 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 |
| 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. |
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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:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation on this study.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bronwen E Shaw, MD, PhD | Center for International Blood and Marrow Transplant Research (CIBMTR)/Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States | ||
| H. Lee Moffitt Cancer Center and Research Institute |
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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