A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life

Location:

Rochester, MN.

Trial status:

Open for Enrollment

Why is this study being done?

The study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unrelated hematopoietic stem cell donors. The study will also assess the hypothesis that young (<18 years) and older (>60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations. An ancillary study of the psychological impact of donation on health-related quality of life (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.

Who is eligible to participate?

Inclusion Criteria: - Donors of any age providing either a first or second BM or PBSC donation - Meet donation criteria per institution policies and procedures - Willing to receive phone follow-up at 1, 6, and 12 months - Signed informed consent for study participation For the HRQoL ancillary study, inclusion criteria: - Related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria - Donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the HRQoL proxy interview - English speaking - Access to a telephone - Willing to participate in pre-donation, 1 month and 1 year follow-up interviews - Signed informed consent for study participation in ancillary study Exclusion Criteria: - Per institutional guidelines - Donors providing unstimulated peripheral blood stem cells or lymphocytes For the HRQoL ancillary study, exclusion criteria: - Children less than or equal to 4 years of age

Last updated:

5/22/2013

NCT ID:

NCT00948636