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

• ClinicalTrials.gov Identifier: NCT03558386
• Recruitment Status: Completed
• First Posted: June 15, 2018
• Last Update Posted: December 2, 2020
• Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborator: Medical College of Wisconsin
• Information provided by (Responsible Party): Center for International Blood and Marrow Transplant Research

Study Description

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).

Condition or disease	Intervention/treatment
Myelodysplastic Syndromes; Hematopoietic Cell Transplant	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 Design

• Study Type: Observational
• Actual Enrollment: 92 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: July 23, 2018
• Actual Primary Completion Date: November 15, 2019
• Actual Study Completion Date: November 15, 2019

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. Long-term post-HCT QOL (in particular physical function and fatigue) for transplant recipients ≥65 years old to those 55-64 years old. [ Time Frame: 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 :

1. Domain-specific QOL scores by age group as assessed by PROMIS measures. [ Time Frame: 6 months-1 year post-HCT, 1 year - 3 years post-HCT, 3 years+ post-HCT ]
2. 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. [ Time Frame: 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 ]
3. 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. [ Time Frame: 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 ]

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94304

United States, Florida

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States, 33612

United States, Michigan

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

United States, Ohio

The Ohio State University

Columbus, Ohio, United States, 43210

United States, Wisconsin

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

Center for International Blood and Marrow Transplant Research

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

More Information

• Responsible Party: Center for International Blood and Marrow Transplant Research
• ClinicalTrials.gov Identifier: NCT03558386
• Other Study ID Numbers: 17-ePRO
• First Posted: June 15, 2018
• Last Update Posted: December 2, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Preleukemia; Myelodysplastic Syndromes; Syndrome; Disease; Pathologic Processes; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Neoplasms