Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database

NCT ID: NCT01353677

Last Updated: 2017-07-25

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

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-10-30

Brief Summary

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This is a multi-institution, non-randomized, prospective pilot study to evaluate the feasibility of collecting quality of life (QOL) data on a large cohort of pediatric and adult allogeneic Hematopoietic stem cell transplantation (HCT) recipients.

Detailed Description

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QOL data will be collected at baseline (pre-transplant), 100 days, 6 months, and 12 months post transplant. The transplant center will consent the patient and administer the baseline QOL surveys. The transplants center will then submit the competed baseline data and patient contact information to the Center for International Blood and Marrow Transplant Research (CIBMTR). The remaining surveys will be administered to the patient from the CIBMTR via paper surveys mailed to the patient.

Conditions

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Hematopoietic Stem Cell Transplantation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HSCT recipients

1. Adult (≥ 18 years), or pediatric (≥ 2 years and \< 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
2. Signed informed consent form from adult patient or parent/guardian of pediatric patient.
3. Patient must have a valid mailing address within the United States to receive QOL surveys.
4. Ability to speak and read English.
5. Patients with access to a telephone.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Adult (≥ 18 years), or pediatric (≥ 2 years and \< 18 years) allogeneic HCT recipient (related, unrelated, or CBU) at participating pilot study transplant centers.
2. Signed informed consent form from adult patient or parent/guardian of pediatric patient.
3. Patient must have a valid mailing address within the United States to receive QOL surveys.
4. Ability to speak and read English.
5. Patients with access to a telephone.
Minimum Eligible Age

2 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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Douglas Rizzo, MD, MS

Role: PRINCIPAL_INVESTIGATOR

CIBMTR/ Medical College of Wisconsin

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

University Hospitals of Cleveland

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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09-SQOL

Identifier Type: -

Identifier Source: org_study_id

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