NCT07501689

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,812

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Jun 2028

Study Start

First participant enrolled

January 29, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

2.4 years

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

cancer preventioncluster trialadolescent healthschool-based intervention

Outcome Measures

Primary Outcomes (1)

  • Change in students' intention to engage in health-promoting behaviors following the completion of the curriculum.

    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 Outcomes (1)

  • Number of student participants and caregiver participants who initiate cancer risk communication in the household.

    End of Study (6 weeks)

Study Arms (2)

Immediate Intervention Delivery

EXPERIMENTAL

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.

Behavioral: CARES4You Curriculum

Delayed Intervention Delivery

PLACEBO COMPARATOR

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.

Behavioral: CARES4You Curriculum

Interventions

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.

Delayed Intervention DeliveryImmediate Intervention Delivery

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adolescents:
  • Age 10-13
  • Attends a NYC Public Middle School
  • Resides in one of the study's four target PPA's
  • Parents/Caregivers:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Dock Street School for STEAM Studies District: 13 School #: K313

Brooklyn, New York, 11201, United States

ACTIVE NOT RECRUITING

P.S/I.S. 173 District: 6 School #: 173

New York, New York, 10033, United States

RECRUITING

I.S. 145 Joseph Pulitzer District 30 School #: Q145

Queens, New York, 11372, United States

ACTIVE NOT RECRUITING

Metropolitan Expeditionary Learning School District 28 School #: Q167

Queens, New York, 11375, United States

ACTIVE NOT RECRUITING

Jonas Bronck Academy District: 7 School #: X043

The Bronx, New York, 10458, United States

RECRUITING

Related Publications (1)

  • Komsany A, McCooty K, Fox J, Shah U, Leak TM, McDonald JA, Terry MB, Soroka O, Phillips E. Integrating Cancer Prevention into Science Education: Development of the CARES4You School-based Curriculum. J Cancer Educ. 2025 Dec 22:10.1007/s13187-025-02812-x. doi: 10.1007/s13187-025-02812-x. Online ahead of print.

    PMID: 41428312BACKGROUND

Related Links

Study Officials

  • Erica G Phillips, MD, MS

    Weill Cornell

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pragmatic cluster non-randomized trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

January 29, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will become available beginning 6 months following publication and ending 5 years following publication.
Access Criteria
Open-access data are publicly accessible; no approval is required.

Locations