St. Jude Cancer Education for Children Program: Evaluation at 4th-Grade Level

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01185093
First received: August 18, 2010
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

The main objectives of the study is to

  • Evaluate the knowledge acquisition and retention of 4th-grade students who participate in the St. Jude Cancer Education for Children Program
  • To examine the relationship between outcome measures (knowledge acquisition and knowledge retention) with covariates of interest such as self-reported age and gender
  • To compare the knowledge scores among schools and identify the schools that may show better improvement than others and factors associated with improvement

Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: St. Jude Cancer Education for Children Program: Evaluation at 4th-Grade Level

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • This study will measure knowledge acquisition and retention of 4th grade students. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Knowledge acquisition will be assessed by taking the differences from first post-test to pre-test scores, obtained from 10 questions on each component of the intervention. A similar analysis will be undertaken by taking the differences from the 2nd post-evaluation to the 1st post-evaluation for each participant to assess knowledge retention.


Secondary Outcome Measures:
  • This study will measure age and gender [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The study will examine the relationship between outcome measures(knowledge acquisition and knowledge retention) with covariates of interest such as self-reported age and gender.

  • This study will measure the knowledge scores among schools [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To compare the knowledge scores among schools and identify the schools that may show better improvement than others and factors associated with improvement


Enrollment: 481
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Fourth grade students
Each participant will attend two presentations and six hands-on activities led by St. Jude faculty and research staff on topics within their expertise, such as cells and cancer, and healthy living. The pre-test will take place within 7±1 days before the program presentations and before students receive copies of the printed material. Two post-tests will take place. The first post-test will be administered within 7±1 days after the final scheduled program presentation and will be a measure of knowledge acquisition. The second post-test will take place 90±7 days post-intervention and will be a measure of knowledge retention.

Detailed Description:

The subjects in this research study will be current 4th-grade students at elementary schools in Memphis, Tennessee who choose to participate in the Program. These participants are not patients of St. Jude Children's Research Hospital. The Program will be implemented over a three-day period. Each student will attend two presentations and six hands-on activities led by St. Jude faculty and research staff on topics within their expertise, such as cells and cancer, and healthy living. Printed materials to be distributed as part of the St. Jude Cancer Education for Children Program have been developed by a multi-disciplinary team of St. Jude employees and local educators and reviewed by national experts for scientific accuracy and appropriate readability. Material includes three illustrated children's books, a laboratory manual, and activity sheets.

One pre- and two post-tests will be administered by designated school teachers. The tests consist of 10 multiple-choice questions per each of three modules(cells, cancer, and healthy living), validated by a group of experts for readability and content relevance. Knowledge acquisition will be assessed by taking the differences from first post-test to pre-test scores, obtained from 10 questions on each component of the intervention, and using one-sample signed rank test to evaluate the improvement in the knowledge scores. A similar analysis will be undertaken by taking the differences from the 2nd post-evaluation to the 1st post-evaluation for each participant to assess knowledge retention.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A convenience sample of schools that agree to participate in the St. Jude Cancer Education for Children Program. 2-3 public schools and 2-3 private schools will be selected in order to achieve a fair representation of the Mid-South area. Based on average class sizes, this study expects to enroll at least 200 public school students and about 100 private school students.

Criteria

Inclusion Criteria:

Study participants are not patients of St. Jude Children's Research Hospital.

  • 4th-grade student
  • Enrolled at a school participating in the St. Jude Cancer Education for Children Program

Exclusion Criteria:

  • Student chooses not to participate in any or all of the activities and/or testing
  • Request by a parent or guardian
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185093

Locations
United States, Tennessee
St . Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Yuri Quintana, Ph.D St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01185093     History of Changes
Other Study ID Numbers: SJCECP
Study First Received: August 18, 2010
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Cells
Prevention
Cancer education
Nutrition
Healthy living
Physical activity
Dangers of tobacco
Sun protection

ClinicalTrials.gov processed this record on September 29, 2014