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

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558386
• Other study ID #: 17-ePRO
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Hematopoietic Cell Transplant
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

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