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

Center for International Blood and Marrow Transplant Research (CIBMTR)

Status: Completed

Conditions: Hematopoietic Cell Transplant; Myelodysplastic Syndromes

Treatments: Behavioral: ePRO survey

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT03558386

17-ePRO

Details and patient eligibility

About

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).

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

92 participants in 2 patient groups

Patients between 55-64 years of age

Description:

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

Treatment:

Behavioral: ePRO survey

Patients 65+ years of age

Description:

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

Treatment:

Behavioral: ePRO survey