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

A Multi-Center, Phase II Cross-sectional Study Investigating Quality of Life in Older vs. Younger Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Myelodysplastic Syndromes: a Companion Study to the CIBMTR 10-CMSMDS-1-Approved Expanded Access Study

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).

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes; Hematopoietic Cell Transplant
• Intervention / Treatment: Behavioral: ePRO survey

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 Type: Observational
• Enrollment (Actual): 92

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Memorial Lutheran Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: 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 record dates

Study Major Dates

• Study Start (ACTUAL): July 23, 2018
• Primary Completion (ACTUAL): November 15, 2019
• Study Completion (ACTUAL): November 15, 2019

Study Registration Dates

• First Submitted: April 10, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (ACTUAL): June 15, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 2, 2020
• Last Update Submitted That Met QC Criteria: November 30, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: 17-ePRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No