Hematopoietic Cell Transplant, Myelodysplastic Syndromes
Conditions
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).
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.
Interventions
BEHAVIORALePRO survey
An electronic patient reported outcomes survey will be completed by the patient.
Sponsors
Medical College of Wisconsin
Center for International Blood and Marrow Transplant Research
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
United States
Outcome results
None listed