NCT03558386

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 92 (actual)
• Sponsor: Center for International Blood and Marrow Transplant Research · Network
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myelodysplastic Syndromes
• Hematopoietic Cell Transplant

Interventions

Type	Name	Description
BEHAVIORAL	ePRO survey	An electronic patient reported outcomes survey will be completed by the patient.

Timeline

• Start date: 2018-07-23
• Primary completion: 2019-11-15
• Completion: 2019-11-15
• First posted: 2018-06-15
• Last updated: 2020-12-02

Locations

6 sites across 1 country: United States