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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:55 - Any
Updated:1/19/2019
Start Date:July 23, 2018
End Date:December 2019
Contact:Alisha Mussetter, BS
Email:amussett@nmdp.org
Phone:763-406-4863

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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).

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.

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
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Detroit, Michigan 48201
Principal Investigator: Joseph Uberti, MD
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(212) 639-2000
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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Principal Investigator: Lori Muffly, MD, MS
Phone: 650-721-4183
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