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

Center for International Blood and Marrow Transplant Research (CIBMTR)

Status: Completed

Conditions: Hematopoietic Stem Cell Transplantation

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT01353677

09-SQOL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

390 participants in 1 patient group

HSCT recipients

Description:

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.