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

NCT ID: NCT03558386

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-23

Study Completion Date

2019-11-15

Brief Summary

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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

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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

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Myelodysplastic Syndromes Hematopoietic Cell Transplant

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

ePRO survey

Intervention Type BEHAVIORAL

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

ePRO survey

Intervention Type BEHAVIORAL

An electronic patient reported outcomes survey will be completed by the patient.

Interventions

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ePRO survey

An electronic patient reported outcomes survey will be completed by the patient.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role collaborator

Center for International Blood and Marrow Transplant Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bronwen E Shaw, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for International Blood and Marrow Transplant Research (CIBMTR)/Medical College of Wisconsin

Locations

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Stanford University

Stanford, California, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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17-ePRO

Identifier Type: -

Identifier Source: org_study_id