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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 10 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Pragmatic cluster non-randomized trial
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: CARES4You Curriculum
    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.
  • Behavioral: CARES4You Curriculum
    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.

Recruiting Locations

P.S/I.S. 173 District: 6 School #: 173
New York, New York 10033
Contact:
Erica Phillips, MD, MS
646-962-5013
erp2001@med.cornell.edu

Jonas Bronck Academy District: 7 School #: X043
The Bronx, New York 10458
Contact:
Erica Phillips, MD, MS
646-962-5013
erp2001@med.cornell.edu

More Details

Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

Rosio Ramos, BA
646 962 5037
ror2023@med.cornell.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.