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

Recruiting

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:

  1. Be assigned to either the control group or the study group; both will receive the same cancer educational curriculum over 5 weeks.
  2. Receive weekly classroom lessons and labs over 5 weeks.
  3. 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.
  4. 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.
  5. Instructors will complete a training program evaluation and a post-curriculum evaluation to assess the impact of the curriculum on their students.

Study Type

Interventional

Enrollment (Estimated)

1812

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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:
      • 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:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Erica G Phillips, MD, MS, Weill Cornell

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 24, 2026

First Submitted That Met QC Criteria

March 24, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

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)?

YES

IPD Plan Description

Individual participant data that underlie the results reported in any publication will be shared after deidentification (text, tables, figures, and appendices).

IPD Sharing Time Frame

Data will become available beginning 6 months following publication and ending 5 years following publication.

IPD Sharing Access Criteria

Open-access data are publicly accessible; no approval is required.

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

No

Studies a U.S. FDA-regulated device product

No

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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