Clincosm LogoSign in Get a demo

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

Sponsor
Center for International Blood and Marrow Transplant Research (Other)
Overall Status
Completed
CT.gov ID
NCT01353677
Collaborator
Medical College of Wisconsin (Other)
390
Enrollment
7
Locations
40
Actual Duration (Months)
55.7
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    390 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pilot Study to Assess the Feasibility of Collecting Quality of Life Data in Collaboration With the Stem Cell Therapeutic Outcomes Database
    Actual Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Oct 30, 2014
    Actual Study Completion Date :
    Oct 30, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      2 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of Florida Gainesville Florida United States 32610
      2 Mayo Clinic Rochester Minnesota United States 55905
      3 Memorial Sloan-Kettering Cancer Center New York New York United States 10065
      4 Cincinnati Children's Hospital Medical Center Cincinnati Ohio United States 45229
      5 University Hospitals of Cleveland Cleveland Ohio United States 44106
      6 Cleveland Clinic Cleveland Ohio United States 44195
      7 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109

      Sponsors and Collaborators

      • Center for International Blood and Marrow Transplant Research
      • Medical College of Wisconsin

      Investigators

      • Principal Investigator: Douglas Rizzo, MD, MS, CIBMTR/ Medical College of Wisconsin

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Center for International Blood and Marrow Transplant Research
      ClinicalTrials.gov Identifier:
      NCT01353677
      Other Study ID Numbers:
      • 09-SQOL
      First Posted:
      May 16, 2011
      Last Update Posted:
      Jul 25, 2017
      Last Verified:
      Jul 1, 2017
      Keywords provided by Center for International Blood and Marrow Transplant Research
      Hematopoietic stem cell transplantation
      QOL

      Study Results

      No Results Posted as of Jul 25, 2017