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CompletedNCT05064410Updated Apr 1, 2026

Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative

An interventional study of Educational Intervention in Colorectal Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 4 months after the study started (first participant enrolled May 2017, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
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Study 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Colon Cancer
  • Cancer prevention
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 188 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
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

Exclusion Criteria:

  • Does not meet inclusion criteria
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralEducational 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.

06

What researchers measure

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.

    Time frame: Baseline, immediately following intervention, at 3 months and at 6 months

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Study locations

1 site
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05064410
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Oct 1, 2021
Start date
May 11, 2017
Primary completion
Jan 3, 2023
Completion
Oct 25, 2023
Last update
Apr 1, 2026

Study contacts

Clement K Gwede, PhD, MPH, RN, FAAN
principal investigator · Moffitt Cancer Center
Cathy D Meade, PhD, RN, FAAN
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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