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Education Sessions for Young Relative Stem Cell Donors
This study is currently recruiting participants.
Verified September 2011 by National Institutes of Health Clinical Center (CC)

First Received on March 7, 2007.   Last Updated on September 29, 2011   History of Changes
Sponsor: National Cancer Institute (NCI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00445380
  Purpose

RATIONALE: An education session using a board game or workbook may increase a young donor's knowledge about stem cell transplant. It may also reduce a donor's anxiety about the procedure.

PURPOSE: This clinical trial is studying education sessions to see how well they increase knowledge and reduce anxiety in young first degree relative stem cell donors.


Condition Intervention
Cancer
Other: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care

Study Type: Interventional
Official Title: Pilot Study of Educational Interventions in Pediatric Hematopoietic Stem Cell Donors to Increase Knowledge of Donation and Transplantation Procedures

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Efficacy of educational intervention [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Donors requiring additional preparation [ Designated as safety issue: No ]
  • Donor anxiety [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2006
Detailed Description:

OBJECTIVES:

Primary

  • Assess young first degree relative stem cell donor comprehension of transplantation procedures and compare knowledge prior to educational interventions (pre- and post-consent information session) to knowledge after educational interventions.

Secondary

  • Assess the efficacy of a workbook intervention as a learning tool for conveying information on stem cell donation and transplantation to pediatric donors.
  • 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.
  • Identify donors who may require additional preparation prior to stem cell collection.
  • Measure donor anxiety symptoms pre- and post-educational intervention and pre- and post-stem cell donation.
  • Explore the relationship between donor knowledge and anxiety symptoms pre- and post-stem cell donation.

OUTLINE: This is a pilot study. Participants are stratified by age (10-15 years of age vs 16-26 years of age).

Participants attend an educational session comprising a board game intervention (ShopTalk) (for participants 10-15 years of age) or a workbook intervention (for participants 16-26 years of age).

Participants take a knowledge-assessment quiz at baseline, 24 hours before and after educational session, and 1 month after educational session. Participants also complete a written anxiety assessment at baseline, 24 hours before educational session, and 1 month after educational session.

PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.

  Eligibility

Ages Eligible for Study:   10 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

DISEASE CHARACTERISTICS:

  • First degree relative donor of a patient undergoing hematopoietic stem cell transplantation
  • Consented to participate in an active bone marrow or peripheral blood stem cell transplantation clinical trial at the NIH

PATIENT CHARACTERISTICS:

  • Able to understand and read English or Spanish
  • No psychiatric or psychological complications or cognitive impairment that would preclude study compliance

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445380

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
Sponsors and Collaborators
Investigators
Principal Investigator: Lori Wiener, PhD NCI - Pediatric Oncology Branch
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00445380     History of Changes
Other Study ID Numbers: 070086, CDR0000534409, NCI-07-C-0086
Study First Received: March 7, 2007
Last Updated: September 29, 2011
Health Authority: Unspecified

Keywords provided by National Institutes of Health Clinical Center (CC):
psychosocial effects of cancer and its treatment
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia, BCR-ABL1 negative
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
primary myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative neoplasm, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012