Protocol Number: 07-C-0086

Title:

Pilot Study of Educational Interventions in Pediatric Hematopoietic Stem Cell Donors to Increase Knowledge of Donation and Transplantation Procedures

Number:

07-C-0086

Summary:

Background:

-Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major organ transplant in the United States.

-Pediatric sibling stem cell donors can experience a variety of psychological difficulties before and after donation with those who feel they are not adequately prepared for possible complications following stem cell donation and transplant describing negative emotions.

-The importance of preparation for children undergoing medical procedures has long been recognized in the field of pediatric psychology

Objectives:

-To assess how prepared pediatric sibling donors are for stem cell donation by assessing their knowledge about stem cell transplants, and to assess their anxiety at different stages of the donation process.

-To assess the effectiveness of a workbook and a board game as tools for conveying information on donation and transplantation to donors.

-To identify donors who may require additional preparation before stem cell collection.

-To explore the relationship between donor knowledge and anxiety symptoms.

Eligibility:

-Stem cell donors ages 10 to 26 years of age

Design:

-Participant's baseline knowledge and anxiety are evaluated.

-Participant's knowledge is reassessed and anxiety evaluated following an information session with the research nurse and doctor about the procedures for stem cell donation and discussion of the consent form for the transplant protocol.

-Participants are separated into two groups. Donors 10 to 15 years of age play a board game; those 16 to 26 years of age are given a workbook on stem cell transplant.

-Participants' knowledge and anxiety are reassessed within 24 hours after working with the educational materials and again 1 month later.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

-Age: 10 to 26 years of age.

-Participants or their parents must consent to participation in active bone marrow and peripheral blood stem cell transplant protocols at the NIH.

-For donors less than 18 years of age, their legal guardian must give informed consent, the donor must give written assent.

-For donors greater than or equal to 18 years of age, ability to give informed consent.

-Participants must understand and read English or Spanish.

EXCLUSION CRITERIA:

-Presence of psychiatric or psychological symptoms which in the judgment of the Principal or Associate Investigators would compromise the donor's ability to engage in the intervention or is likely to interfere with the study procedures or results.

-Preciously identified cognitive impairment, which in the judgment of the Principal or Associate Investigators would compromise the donor's ability to understand the educational materials or the board game rules and procedures, and is likely to interfere with the study procedures or results.

Special Instructions:

Currently Not Provided

Keywords:

Sibling Donor

Educational

Game

Work Book

Stem Cell Transplant

Recruitment Keyword(s):

Sibling Donor

Stem Cell Transplant

Condition(s):

Hematopoietic Stem Cell

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Cancer Institute

Contact(s):

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):

Lipton JM. Peripheral blood as a stem cell source for hematopoietic cell transplantation in children: is the effort in vein? Pediatr Transplant. 2003;7 Suppl 3:65-70. Review.

Grupp SA, Frangoul H, Wall D, Pulsipher MA, Levine JE, Schultz KR. Use of G-CSF in matched sibling donor pediatric allogeneic transplantation: a consensus statement from the Children's Oncology Group (COG) Transplant Discipline Committee and Pediatric Blood and Marrow Transplant Consortium (PBMTC) Executive Committee. Pediatr Blood Cancer. 2006 Apr;46(4):414-21. Review.

Wiley FM, Lindamood MM, Pfefferbaum-Levine B. Donor-patient relationship in pediatric bone marrow transplantation. J Assoc Pediatr Oncol Nurses. 1984 Summer;1(3):8-14. No abstract available.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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