Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative

Sponsor

H. Lee Moffitt Cancer Center and Research Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05064410

Collaborator

National Cancer Institute (NCI) (NIH)

100

Enrollment

Location

Arm

23.5

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Educational Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening [Baseline, immediately following intervention, at 3 months and at 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lee Moffitt Cancer Center and Research Institute

ClinicalTrials.gov Identifier:

NCT05064410

Other Study ID Numbers:

MCC-19103
3P30CA076292-21S3

First Posted:

Oct 1, 2021

Last Update Posted:

Jul 28, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute

Colon Cancer

Cancer prevention

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Jul 28, 2022