Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Educational Intervention

• Study Type: Interventional
• Enrollment (Actual): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between 45 and 75 years of age
• Spanish or English speaking
• Able to provide informed consent
• Reside in the Tampa Bay area (namely Hillsborough, Pinellas, Polk or Pasco county)

Exclusion Criteria:

• Does not meet inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Educational Intervention and Referral for Fecal Immunochemical Test (FIT) Kit or Colonoscopy; 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.

Behavioral: Educational Intervention; The colorectal cancer (CRC) educational activities will include the use of NCI CRC resources and materials, including a PowerPoint presentation, and CRC educational models and displays. The CRC education will be delivered in Spanish and English, and will consist of pre and post knowledge assessments including screening and behavioral intention questions. The educational intervention will take approximately 45 minutes-1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening	Pre and post assessment surveys completed by participants will consist of 14 questions assessing knowledge of CRC, risk factors, and screening options and recommendations. Assessments also include 5 questions to determine intentions to change screening/health behaviors, speaking to one's healthcare provider about screening, getting screened, and talking with family/friends about CRC and CRC screening. 3-month follow up survey consists of 5 sections to determine CRC knowledge, screening behavior since baseline, future screening plans, talking with family and friends about CRC screening, and behavior changes in eating habits and physical activity since partaking in the educational session. 6-month survey consists of 5 questions about screening since the 3-month follow up survey. Those needing to complete the 6-month follow up survey are those that were screened at the time of the 3-month follow-up but had not received final diagnostic results.	Baseline, immediately following intervention, at 3 months and at 6 months

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Clement K Gwede, PhD, MPH, RN, FAAN, Moffitt Cancer Center; Principal Investigator: Cathy D Meade, PhD, RN, FAAN, Moffitt Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Colon Cancer; Cancer prevention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MCC-19103; 3P30CA076292-21S3 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No