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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03558386
Other study ID # 17-ePRO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 23, 2018
Est. completion date November 15, 2019

Study information

Verified date November 2020
Source Center for International Blood and Marrow Transplant Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date November 15, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
United States The Ohio State University Columbus Ohio
United States Karmanos Cancer Institute Detroit Michigan
United States Froedtert Memorial Lutheran Hospital Milwaukee Wisconsin
United States Memorial Sloan Kettering Cancer Center New York New York
United States Stanford University Stanford California
United States H. Lee Moffitt Cancer Center and Research Institute Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Center for International Blood and Marrow Transplant Research Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
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