HealthyNCT01591213
St. Jude Cancer Education for Children Program: The Feasibility of Teacher Delivery (Pilot Study)
An observational study of Healthy, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
-The St. Jude Cancer Education for Children Program was created in 2006 as part of the outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research Hospital. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 426 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Fourth grade students enrolled in Memphis-area schools.
Who may be able to join
- Located in the United States or United States territories
- District \& school provide permission
- 3rd, 4th, or 5th grade student with cognitive capacity to complete questionnaires (as determined by the teacher)
- Assents to study participation
Who cannot join
- Located outside of the United States or United States territories
- Student does not assent to participation
- Student without cognitive capacity to complete questionnaires (as determined by the teacher)
- Parent or guardian refuses consent
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 St. Jude Cancer Education for Children Program was created in 2006 as part of the outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research Hospital. The curriculum is designed to teach schoolchildren about cancer and dispel common misconceptions, inform students about healthy lifestyle choices that can translate to reduced cancer risk in adulthood, and to inspire an interest in science and scientific careers. In the 2010-2011 school year, researchers examined the impact of the program in regard to knowledge.
It has always been clear that St. Jude personnel are limited to visiting a small number of schools in person each year so in 2011, a teacher's kit to the education program was created. The kit includes all the lesson plans needed to complete the program without the presence of St. Jude staff members. As a result, researchers at St. Jude Children's Research Hospital want to test the feasibility of the intervention by schoolteachers, and how this mechanism of delivery will affect student knowledge, attitudes, and health behaviors associated with cancer and healthy living.
Read the detailed description
Teachers who agree to participate will use the teacher's kit developed by the St. Jude International Outreach Program to deliver the St. Jude Cancer Education for Children curriculum to 4th grade students over the course of 1 week. Pre and post survey data will be collected from students to measure knowledge, beliefs, attitudes, perceptions of vulnerability, intentions, and behaviors associated with cancer and healthy living. Rates of compliance and feedback about the curriculum will be collected from teachers via curriculum checklist, survey, and interviews.
Primary Objective:
- To determine if it is feasible for classroom teachers to implement the St. Jude Cancer Education for Children Program.
Secondary/Exploratory Objectives:
- To determine factors that may contribute to the program's feasibility such as school and teacher characteristics.
- To measure the impact of the intervention on student knowledge, beliefs, attitudes, perceptions of vulnerability, intentions, and self-reported health behaviors.
- Conditions
- Healthy
- Keywords
- Cancer education, Prevention education, Volunteers
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 |
|---|---|---|
| Healthy Volunteers | Fourth grade students enrolled in Memphis-area schools. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of compliance
Delivery of the educational curriculum by classroom teachers will be demonstrated to be a feasible method of delivering the St. Jude Cancer Education for Children Program. The program will be determined to be feasible if 80% of the schools that agree to participate complete the delivery of the program. A complete delivery will be defined as all grade consenting teachers delivering 2/3 of the educational content in each of the three modules.
Measured: 1 week (at end of three teaching modules)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Ayers, MS, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01591213
- Sponsor's protocol ID
- XPD12-040 SJCECP2
- Status last verified
- Jan 2015
- First submitted
- 1 May 2012
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- St. Jude Cancer Education for Children Program: The Feasibility of Teacher Delivery (Pilot Study)
- ClinicalTrials.gov ID
- NCT01591213
- Acronym / sponsor ID
- XPD12-040 SJCECP2
- Conditions
- Healthy
- Keywords
- Cancer education, Prevention education, Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
-The St. Jude Cancer Education for Children Program was created in 2006 as part of the outreach mandate of the Comprehensive Cancer Center at St. Jude Children's Research Hospital. The curriculum is designed to teach schoolchildren about cancer and dispel common misconceptions, inform students about healthy lifestyle choices that can translate to reduced cancer risk in adulthood, and to inspire an interest in science and scientific careers. In the 2010-2011 school year, researchers examined the impact of the program in regard to knowledge.
It has always been clear that St. Jude personnel are limited to visiting a small number of schools in person each year so in 2011, a teacher's kit to the education program was created. The kit includes all the lesson plans needed to complete the program without the presence of St. Jude staff members. As a result, researchers at St. Jude Children's Research Hospital want to test the feasibility of the intervention by schoolteachers, and how this mechanism of delivery will affect student knowledge, attitudes, and health behaviors associated with cancer and healthy living.
Detailed description
Teachers who agree to participate will use the teacher's kit developed by the St. Jude International Outreach Program to deliver the St. Jude Cancer Education for Children curriculum to 4th grade students over the course of 1 week. Pre and post survey data will be collected from students to measure knowledge, beliefs, attitudes, perceptions of vulnerability, intentions, and behaviors associated with cancer and healthy living. Rates of compliance and feedback about the curriculum will be collected from teachers via curriculum checklist, survey, and interviews.
Primary Objective:
- To determine if it is feasible for classroom teachers to implement the St. Jude Cancer Education for Children Program.
Secondary/Exploratory Objectives:
- To determine factors that may contribute to the program's feasibility such as school and teacher characteristics.
- To measure the impact of the intervention on student knowledge, beliefs, attitudes, perceptions of vulnerability, intentions, and self-reported health behaviors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Fourth grade students enrolled in Memphis-area schools. |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Fourth grade students enrolled in Memphis-area schools.
Key inclusion criteria (4 listed)
- Located in the United States or United States territories
- District \& school provide permission
- 3rd, 4th, or 5th grade student with cognitive capacity to complete questionnaires (as determined by the teacher)
- Assents to study participation
Key exclusion criteria (4 listed)
- Located outside of the United States or United States territories
- Student does not assent to participation
- Student without cognitive capacity to complete questionnaires (as determined by the teacher)
- Parent or guardian refuses consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of compliance
Time frame: 1 week (at end of three teaching modules)
Delivery of the educational curriculum by classroom teachers will be demonstrated to be a feasible method of delivering the St. Jude Cancer Education for Children Program. The program will be determined to be feasible if 80% of the schools that agree to participate complete the delivery of the program. A complete delivery will be defined as all grade consenting teachers delivering 2/3 of the educational content in each of the three modules.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Ayers, MS principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of compliance (time frame: 1 week (at end of three teaching modules)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2015.