Educational Intervention for Colorectal Cancer Screening

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Disqualifiers: Does not meet inclusion criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

188 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to provide educational materials and information regarding colorectal cancer (CRC), CRC screenings, and United States Preventive Services Task Force's (USPSTF) screening recommendations. USPSTF recommends screening for colorectal cancer starting at age 45 years and continuing until age 75 years.

Research Team

Clement K Gwede, PhD, MPH, RN, FAAN

Principal Investigator

Moffitt Cancer Center

Cathy D Meade, PhD, RN, FAAN

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

This trial is for English or Spanish speakers living in the Tampa Bay area (Hillsborough, Pinellas, Polk, or Pasco county), aged between 45 and 75 years old who can consent to participate. It's not open to those outside this age range or location.

Inclusion Criteria

Reside in the Tampa Bay area (namely Hillsborough, Pinellas, Polk or Pasco county)

Able to provide informed consent

I am between 45 and 75 years old.

Exclusion Criteria

Does not meet inclusion criteria

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive educational materials and information regarding colorectal cancer, screenings, and recommendations

1 week

1 session (in-person, virtual, or phone)

Follow-up

Participants complete pre and post assessment surveys and follow-up surveys to assess knowledge and behavior changes

6 months

Surveys at baseline, immediately post-intervention, 3 months, and 6 months

Treatment Details

Interventions

• Educational Intervention

Trial Overview The study provides educational materials about colorectal cancer and screening based on US Preventive Services Task Force recommendations. The goal is to see if these interventions increase awareness and screenings among participants.

Participant Groups

Group I: Educational Intervention and Referral for Fecal Immunochemical Test (FIT) Kit or Colonoscopy Experimental Treatment 1 Intervention

The Community Health Educator (CHE) will provide online, phone or in-person colorectal cancer (CRC) early detection, prevention, and screening education to increase knowledge of CRC and the importance of screening. These sessions will be conducted in small in-person sessions, virtually within a group, virtually via a self-paced/self-directed online learning module, or one-on-one via phone. Additionally, the CHE will provide information regarding FIT kit and colonoscopy screening and the screening process for attendees. The CHE and research assistant will be prepared to provide access to screening resources and services through participants' existing coverage. Those participants who do not have a primary care provider will be provided information on obtaining FIT kits through the mechanisms of the Federally Qualified Health Center (FQHC) and/or a colonoscopy through the cancer center on a case by case basis.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+