CancerNCT01185093
St. Jude Cancer Education for Children Program: Evaluation at 4th-Grade Level
An observational study of Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 481 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2011
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Student chooses not to participate in any or all of the activities and/or testing
- Request by a parent or guardian
Trial locations and contacts
1 site in 1 country.
United States1 site
St . Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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
Read the 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.
- Conditions
- Cancer
- Keywords
- Cells, Prevention, Cancer education, Nutrition, Healthy living, Physical activity, Dangers of tobacco, Sun protection
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study will measure knowledge acquisition and retention of 4th grade students.
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.
Measured: 1 year
Secondary outcomes (2)
This study will measure age and gender
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.
Measured: 1 year
This study will measure the knowledge scores among schools
To compare the knowledge scores among schools and identify the schools that may show better improvement than others and factors associated with improvement
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 481 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuri Quintana, Ph.D, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01185093
- Sponsor's protocol ID
- SJCECP
- Status last verified
- Feb 2012
- First submitted
- 18 Aug 2010
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No