We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01445158
First Posted: October 3, 2011
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

Background:

  • Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major organ transplant in the United States.
  • Pediatric 1st degree 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 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.

Condition
Normal Donors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Educational Interventions in Pediatric Hematopoietic Stem Cell Donors to Increase Knowledge of Donation and Transplantation Procedures

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • Assess 1st degree relative stem cell donor comprehension of transplant procedures [ Time Frame: Prior to relatives transplant ]

Secondary Outcome Measures:
  • Assess efficacy of workbook intervention as a learning tool [ Time Frame: Prior to relatives transplant ]
  • Assess effectiveness of a board game as a learning tool [ Time Frame: Prior to relatives transplant ]
  • Measure donor anxiety pre-and post educational intervention and pre and post donation [ Time Frame: Prior to relatives transplant ]

Enrollment: 17
Study Start Date: January 30, 2007
Detailed Description:

Background:

  • Hematopoietic Stem Cell Transplant (HSCT) represents the second most frequent major organ transplant in the United States.
  • A variety of psychological difficulties in sibling donors post-stem cell donation are reported, including withdrawal, guilt, anger, depression, anxiety, mild to severe psychopathology, and post-traumatic stress symptomatology.
  • The importance of preparation for children undergoing medical procedures has long been recognized in the field of pediatric psychology. In previous research, siblings who felt they were not adequately prepared for possible complications following HSCT donation and transplant often described negative emotions.
  • Some siblings have reported feeling pressured and coerced to become a donor, while others describe a lack of attention to their physical fears associated with donation and their psychological concerns.
  • No prospective studies examining educational tools and transplant knowledge in sibling stem cell donors are currently available.

Objectives:

  • To assess pediatric 1st degree stem cell donor comprehension of transplant procedures and compare knowledge prior to educational interventions (pre and post-consent informational session) to knowledge following educational interventions.
  • To assess the effectiveness of a workbook intervention as a learning tool for conveying information on stem cell donation and transplantation to pediatric donors.
  • To assess the effectiveness of a board game intervention (ShopTalk) as a learning tool for conveying information on stem cell donation and transplantation to pediatric donors.
  • To identify donors who may require additional preparation prior to stem cell collection.
  • To measure donor anxiety pre and post the educational intervention and stem cell donation and explore the relationship between donor knowledge and anxiety symptoms.

Eligibility:

  • 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.

Design:

  • Baseline knowledge will be assessed following consent.
  • Knowledge will be reassessed following the information session for the transplant protocol
  • Donors will be stratified into 2 groups by age. Donors ages 10 to 15 will be scheduled the following day to play a game called ShopTalk. Donors ages 16 to 26 will be given a workbook on HSCT specifically designed for 1st degree stem cell donors. Knowledge will be reassessed following the administration of these interventions.
  • A follow-up assessment will be administered to all participants 1 month after the post intervention test was administered.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01445158


Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Lori Wiener, Ph.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01445158     History of Changes
Obsolete Identifiers: NCT00445380
Other Study ID Numbers: 070086
07-C-0086
First Submitted: September 30, 2011
First Posted: October 3, 2011
Last Update Posted: October 19, 2017
Last Verified: September 21, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
ShopTalk
Comprehension
Donors
Education
Stem Cell Transplant
Sibling Donor