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

Completed

• Conditions: Myelodysplastic Syndromes; Hematopoietic Cell Transplant
• Interventions: Behavioral: ePRO survey

• Registration Number: NCT03558386
• Lead Sponsor: Center for International Blood and Marrow Transplant Research

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.

Study Timeline

• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Study Start: 2018-07-23
• Primary Completion: 2019-11-15
• Study Completion: 2019-11-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients 65+ years of age	ePRO survey	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
Patients between 55-64 years of age	ePRO survey	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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 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

Trial Locations

Locations (6)

Stanford University; 🇺🇸 Stanford, California, United States

H. Lee Moffitt Cancer Center and Research Institute; 🇺🇸 Tampa, Florida, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Froedtert Memorial Lutheran Hospital; 🇺🇸 Milwaukee, Wisconsin, United States