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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01353677

Acronym

09-SQOL

Enrollment

390

Registered

2011-05-16

Start date

2011-07-31

Completion date

2014-10-30

Last updated

2017-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Hematopoietic stem cell transplantation, QOL

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results