Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative

NCT05064410 | Completed

• 2 other identifiers: MCC-191033P30CA076292-21S3
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Colon Cancer; Cancer prevention

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Educational Intervention and Referral for Fecal Immunochemical Test (FIT) Kit or Colonoscopy

EXPERIMENTAL

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

Interventions

Educational Intervention BEHAVIORAL

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.

Educational Intervention and Referral for Fecal Immunochemical Test (FIT) Kit or Colonoscopy

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Clement K Gwede, PhD, MPH, RN, FAAN

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Cathy D Meade, PhD, RN, FAAN

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: May 11, 2017
• Primary Completion: January 3, 2023
• Study Completion: October 25, 2023
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)