Cancer Risk FactorsCARES4YouNCT07501689
Using Middle School Science Teachers to Address Cancer Health Disparities
A study testing CARES4You Curriculum in people with Cancer Risk Factors and Cancer Prevention, run by Weill Medical College of Cornell University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer Risk Factors, Cancer Prevention
- What is being tested?
- CARES4You Curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,812 participants
- Where
- 5 sitesUnited States
- Study dates
- 29 Jan 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 2 recruiting
- Active, not recruiting
Dock Street School for STEAM Studies District: 13 School #: K313
Brooklyn, New York, 11201
- Recruiting
P.S/I.S. 173 District: 6 School #: 173
New York, New York, 10033
Erica Phillips, MD, MS, 646-962-5013, erp2001@med.cornell.edu
- Active, not recruiting
I.S. 145 Joseph Pulitzer District 30 School #: Q145
Queens, New York, 11372
- Active, not recruiting
Metropolitan Expeditionary Learning School District 28 School #: Q167
Queens, New York, 11375
- Recruiting
Jonas Bronck Academy District: 7 School #: X043
The Bronx, New York, 10458
Erica Phillips, MD, MS, 646-962-5013, erp2001@med.cornell.edu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cancer Risk Factors, Cancer Prevention
- Being tested
- CARES4You Curriculum
- Keywords
- cancer prevention, cluster trial, adolescent health, school-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARES4You CurriculumBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: CARES4You Curriculum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, End of Study (6 weeks)
Secondary outcomes (1)
Number of student participants and caregiver participants who initiate cancer risk communication in the household.
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.
Measured: End of Study (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start29 Jan 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Risk FactorsStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pragmatic cluster non-randomized trial
- Masking
- None (open label)
- Enrolment
- 1,812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Erica G Phillips, MD, MS, Principal investigator, Weill Cornell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501689
- Sponsor's protocol ID
- 22-12025527
- Other IDs
- U54CA280808-01, NYC DOE 4928
- Acronym
- CARES4You
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in any publication will be shared after deidentification (text, tables, figures, and appendices).
Publications
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.
PubMed 41428312
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Middle School Science Teachers to Address Health Disparities
- ClinicalTrials.gov ID
- NCT07501689
- Acronym / sponsor ID
- CARES4You / 22-12025527
- Conditions
- Cancer Risk Factors, Cancer Prevention
- Keywords
- cancer prevention, cluster trial, adolescent health, school-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,812 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- 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 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pragmatic cluster non-randomized trial
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Delivery | Experimental | Behavioral: CARES4You CurriculumStudents 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. |
| Delayed Intervention Delivery | Placebo comparator | Behavioral: CARES4You CurriculumSchools 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. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Adolescents:
- Age 10-13
- Attends a NYC Public Middle School
- Resides in one of the study's four target PPA's
- Parents/Caregivers:
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CARES4You CurriculumCARES4You 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. | Behavioural | Delayed Intervention Delivery, Immediate Intervention Delivery |
Primary outcome
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.
1 secondary outcome
Number of student participants and caregiver participants who initiate cancer risk communication in the household.
Time frame: End of Study (6 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 41428312Komsany 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.
- The study website is part of the Social Capital (SoCa) Center website and provides an overview of the CARES4You project, including its goals, curriculum components, and participating investigators. The SoCa Center is a collaborative research initiative fLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in any publication will be shared after deidentification (text, tables, figures, and appendices).
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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.
Erica G Phillips, MD, MS principal investigator
Weill Cornell
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CARES4You Curriculum in people with Cancer Risk Factors and Cancer Prevention, run by Weill Medical College of Cornell University at 5 sites 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 9 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rosio Ramos, BA (646 962 5037, ror2023@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in students' intention to engage in health-promoting behaviors following the completion of the curriculum. (time frame: Baseline, End of Study (6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07501689, which also lists 1 linked publication.
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 30 Mar 2026.