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

Study ID
STU 022011-190

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Children's Medical Center-Dallas
  • UT Southwestern Ambulatory Services
  • UT Southwestern University Hospital– Zale Lipshy
  • UT Southwestern University Hospital—St. Paul

Contact
Joyce Bolluyt
214-648-7007
joyce.bolluyt@utsouthwestern.edu

Principal Investigator
Madhuri Vusirikala

Summary

This study will assess medical toxicities occurring in related donors within the first year after hematopoietic stem cell collection from related donors. All sequential related donors at participating centers over an accrual period of 3.5 years will be offered trial participation. Data will include baseline and collection-day forms, along with severe adverse event (SAE) reporting. Follow-up medical toxicity data will be gathered at one, six, and twelve months. A concomitant cohort of NMDP unrelated donors will be used as a comparator.
In the ancillary study, HRQoL outcomes will be measured and compared in randomly selected cohorts of related pediatric, related adult, related older adult, and unrelated adult donors. HRQoL data will be gathered pre-donation, and at one and twelve months through a computer-assisted telephone interviewing (CATI) system housed in the Survey Research Program (SRP) at the University of Pittsburgh. The psychosocial tools include well-validated HRQoL instruments for both adults and children (SF-36 and PedsQL(TM) 4.0) that form the basis of key comparisons across RD, URD, and normative non-donor cohorts. The pediatric cohort will undergo HRQoL assessment both by direct reporting and proxy. The PedsQL(TM) tool has been validated for both types of reporting down to age 5, the youngest age allowed in the pediatric HRQoL cohort.
Approximately 2,300 related donors are projected to be enrolled on the toxicity portion of the study over a 3.5 year period. Four hundred donors (300 related and 100 unrelated) consenting to participate in the ancillary HRQoL will be randomized to the HRQoL cohort. The accrual period is 3.5 years. All donors will be followed for medical events for one year after their stem cell collection. A subset of 400 donors will be followed for HRQoL for one year after their stem cell collection.

Participant Eligibility

Primary study
1. Donors of any age providing either a first or second BM or PBSC donation.
2. Meet donation criteria per institution policies and procedures.
3. Willing to receive phone follow-up from NMDP research staff at 1, 6 and 12 months.
4. Signed informed consent for study participation.


Ancillary study

1. Related donors age ≥ 5, eligible and consented to the primary trial by the inclusion criteria listed in section 2.3 above. Donors may choose to only participate in the medical toxicity portion of the study (i.e., not participate in the HRQoL ancillary study).
2. Only donors giving a first donation are eligible for randomization to the HRQoL ancillary study.
3. Donors should be competent to answer the psychological assessment questions by themselves (adult cohorts). For the pediatric cohort (ages 5-17), the child donor should be willing/able to respond to psychological assessment questions and have an appropriate proxy (i.e. parent/guardian) also willing/able to complete the HRQoL proxy interview.
4. English speaking.
5. Access to a telephone for interviews.
6. Willing to participate, if chosen, in pre-donation, one month and one year follow-up interviews.
7. Signed informed consent for study participation in the HRQoL ancillary study.