Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database (09-SQOL)

Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic Stem Cell Transplantation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 390

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals of Cleveland
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Pediatric and adult allogeneic HCT recipients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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

Collaborators and Investigators

• Sponsor: Center for International Blood and Marrow Transplant Research
• Collaborators: Medical College of Wisconsin
• Investigators: Principal Investigator: Douglas Rizzo, MD, MS, CIBMTR/ Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): October 30, 2014
• Study Completion (Actual): October 30, 2014

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 13, 2011
• First Posted (Estimate): May 16, 2011

Study Record Updates

• Last Update Posted (Actual): July 25, 2017
• Last Update Submitted That Met QC Criteria: July 24, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Hematopoietic stem cell transplantation; QOL
• Other Study ID Numbers: 09-SQOL