- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501689
Using Middle School Science Teachers to Address Cancer Health Disparities (CARES4You)
Using Middle School Science Teachers to Address Health Disparities
The CARES4You study is testing a middle school science curriculum designed to teach students about cancer risk and prevention. The lessons are taught by regular science teachers during class time and are aligned with national science education standards. The curriculum includes six units (14 lessons) that help students learn about cancer, understand how lifestyle and environmental factors influence risk, and think about ways to make healthy choices.
The study will take place in 10 public middle schools in New York City. Some schools will begin using the CARES4You curriculum right away, while others will continue with their usual science lessons and receive the program later. Researchers will compare the two groups of schools.
The main goal of the study is to see whether the curriculum increases students' intentions to engage in healthy behaviors that may reduce cancer risk. The study will also examine whether students talk more with their caregivers about cancer risk and prevention after participating in the program. Caregivers may also report on some health behaviors in the household.
If the program is effective, CARES4You could provide schools with a practical and sustainable way to teach cancer prevention and promote healthy behaviors among adolescents and their families.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators will evaluate whether the CARES4You intervention modifies health-promoting behavior intentions among middle school students in New York City.
Participants in the control arm will receive the exact same 5-week educational curriculum as those in the intervention arm.
Participants will:
- Be assigned to either the control group or the study group; both will receive the same cancer educational curriculum over 5 weeks.
- Receive weekly classroom lessons and labs over 5 weeks.
- Students will complete a survey before and after the administration of the curriculum intervention. These questionnaires evaluate students' change in knowledge related to the curriculum, and questions about their cancer risk behaviors, and communication styles at home.
- Caregivers of students in the intervention schools only will complete a survey at one time point and receive a $40 electronic gift card for completing the survey at the end of the curriculum implementation phase.
- Instructors will complete a training program evaluation and a post-curriculum evaluation to assess the impact of the curriculum on their students.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rosio Ramos, BA
- Phone Number: 646 962 5037
- Email: ror2023@med.cornell.edu
Study Contact Backup
- Name: Alia Komsany, PhD
- Phone Number: 646-962-5036
- Email: alk4019@med.cornell.edu
Study Locations
-
-
New York
-
Brooklyn, New York, United States, 11201
- Active, not recruiting
- Dock Street School for STEAM Studies District: 13 School #: K313
-
New York, New York, United States, 10033
- Recruiting
- P.S/I.S. 173 District: 6 School #: 173
-
Contact:
- Erica Phillips, MD, MS
- Phone Number: 646-962-5013
- Email: erp2001@med.cornell.edu
-
Queens, New York, United States, 11372
- Active, not recruiting
- I.S. 145 Joseph Pulitzer District 30 School #: Q145
-
Queens, New York, United States, 11375
- Active, not recruiting
- Metropolitan Expeditionary Learning School District 28 School #: Q167
-
The Bronx, New York, United States, 10458
- Recruiting
- Jonas Bronck Academy District: 7 School #: X043
-
Contact:
- Erica Phillips, MD, MS
- Phone Number: 646-962-5013
- Email: erp2001@med.cornell.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adolescents:
- Age 10-13
- Attends a NYC Public Middle School
- Resides in one of the study's four target PPA's
- Parents/Caregivers:
- 18 years of age or older
- Has at least one child registered for middle school in NYC that resides with them
- Resides in one of the study's four target PPA's
- Able to provide informed consent
Exclusion Criteria:
- Adolescents: Students who do not attend one of the participating NYC Public Middle Schools
- Parents/Caregivers: Caregivers who do not have a child that attends one of the participating NYC Public Middle Schools
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Intervention Delivery
Students in the immediate intervention group will receive the CARES4You curriculum as part of their regular science class. They will complete study assessments before the curriculum begins (baseline) and again approximately six weeks later, after the curriculum has been delivered. Caregivers will complete a one-time survey about cancer risk communication in the household and their own health behaviors approximately two weeks after the curriculum has been completed in their child's classroom. |
CARES4You is a teacher-delivered middle school science curriculum focused on cancer risk and prevention.
Public middle schools in New York City self-select into either an immediate-intervention group or a delayed-intervention group.
In both groups, grade-level science teachers deliver the same curriculum during regular 50-minute science classes over approximately five weeks.
The program includes six units delivered across 14 lessons, typically taught 4-5 days per week.
Units cover Cancer Genetics, Cancer Epidemiology, Media Literacy and Tobacco Advertising, Nutrition and Cancer, Biotechnology and Cancer, and Cancer Risk Reduction.
Lessons combine brief instruction with interactive activities such as identifying cancer risk factors and discussing ways families can reduce risk.
Students also complete a final cumulative project.
|
|
Placebo Comparator: Delayed Intervention Delivery
Schools assigned to the delayed intervention group will continue with their usual science curriculum during the initial study period.
Students will complete the same study assessments as the intervention group at baseline and approximately six weeks later.
After completion of the follow-up assessments, these schools will implement the CARES4You curriculum the following semester or academic year.
|
CARES4You is a teacher-delivered middle school science curriculum focused on cancer risk and prevention.
Public middle schools in New York City self-select into either an immediate-intervention group or a delayed-intervention group.
In both groups, grade-level science teachers deliver the same curriculum during regular 50-minute science classes over approximately five weeks.
The program includes six units delivered across 14 lessons, typically taught 4-5 days per week.
Units cover Cancer Genetics, Cancer Epidemiology, Media Literacy and Tobacco Advertising, Nutrition and Cancer, Biotechnology and Cancer, and Cancer Risk Reduction.
Lessons combine brief instruction with interactive activities such as identifying cancer risk factors and discussing ways families can reduce risk.
Students also complete a final cumulative project.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in students' intention to engage in health-promoting behaviors following the completion of the curriculum.
Time Frame: Baseline, End of Study (6 weeks)
|
Intent to engage in health-promoting behaviors will be assessed by an adapted nine-item instrument.
The response scale for each question item ranges from 0 (does not apply to me) to 3 (very likely) with a sum score ranging from 0 to 27.
Higher scores represent a greater intention to follow health-promoting behaviors.
|
Baseline, End of Study (6 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of student participants and caregiver participants who initiate cancer risk communication in the household.
Time Frame: End of Study (6 weeks)
|
Cancer risk communication will be assessed by a one item instrument.
The response scale for the question ranges from 0 (no) to 1 (yes) with a yes indicating if the student participant has spoken with a caregiver participant about cancer.
|
End of Study (6 weeks)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Erica G Phillips, MD, MS, Weill Cornell
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-12025527
- U54CA280808-01 (U.S. NIH Grant/Contract)
- NYC DOE 4928 (Other Identifier: Department of Education)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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