Addressing Colorectal Cancer in South Florida Firefighters

The standard way of screening for colorectal cancer is to have a series of fecal blood tests, where a sample is taken from a participant's stool, or an endoscopic procedure performed by a doctor, where a camera is used to look inside the bowel. This research study will use a test performed by the participant. This test will look for changes in the stool that can identify if participants are at higher risk for cancer.

Another aim of this study is to better understand what firefighters and retired firefighters think about colorectal cancer and other health issues. This information will help us develop programs that may improve colorectal cancer outcomes in the firefighter community.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; CRC
• Intervention / Treatment: Other: Fecal Immunochemical Test; Other: Septin9 Test

• Study Type: Interventional
• Enrollment (Actual): 646
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• For this study, participation is open to active and retired firefighters:

  1. ≥ 40 and ≤ 65 years of age,
  2. who work or worked in Florida Fire and Rescue departments and
  3. report never having fecal occult blood test (FOBT) or sigmoidoscopy/colonoscopy in their life or only one FOBT in the past year, a sigmoidoscopy in the last 5 years or a colonoscopy in the last 10 years. The research assistant will assess eligibility using a brief screener that will be completed online via RedCAP.
• For years 2 and 3 of the study, the investigators will enroll previously eligible participants who did not complete colorectal cancer (CRC) screening during year 1. The investigators will also enroll participants who completed fecal immunochemical test (FIT) with our study during year 1 and 2. They will be contacted via RedCAP and a follow up phone call at the 1 year mark of their previous screening. Based on national guidelines, FIT screening is suggested on a yearly basis. The eligibility criteria will be the same and participants will sign a revised informed consent form, stating that they understand that they are being re-consented for the same study.
• Participants, ages 50-65 years old, meeting the above criteria who declined the offered standard-of-care FIT will then be offered the blood-based septin9 test 90 days from the initial offering. FDA guidelines require the participant to be at least 50 years old to participate in the septin9 blood collection. The blood based test will be collected by a nurse or certified phlebotomist in the community setting.

Exclusion Criteria:

• Individuals, who have a personal history of CRC, inflammatory bowel disease (ie, Crohn disease involving the colon or ulcerative colitis) will be excluded from participation as these conditions increase the likelihood of positive test results not associated with the onset or recurrence of CRC disease. Additionally, individuals will be excluded if they are not physically capable of performing the FIT themselves.
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIT Group; Participants aged 40-65 years will receive the self-administered FIT test by mail including instructions for obtaining and returning their stool specimens. Participants will be in this group for up to 6 months.	Other: Fecal Immunochemical Test; The Fecal Immunochemical Test (FIT) is self-administered one-time for participants, per standard of care. This allows participants to obtain their own stool specimens from bowel movements without having a regular colorectal screening procedure in the doctor's office. Participants will use the FIT at the time of their next bowel movement and return their specimens to the laboratory by mail on the same or next day.; Other Names: FIT
Experimental: Septin9 Test Group; Participants aged 50-65 years who declined the initial offer of FIT, will complete a 10-15 minute questionnaire about their personal health, quality of life, and health-related to colorectal cancer including screening history and smoking. Participants will be in this group for up to 6 months.	Other: Septin9 Test; Septin9 (SEPT9) is a blood-based test that will be offered to eligible participants one-time who refused the FIT. Participants will undergo a blood draw collected by a nurse or certified phlebotomist, 90 days after their refusal of the initial offer of FIT.; Other Names: SEPT9

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Participants Completing FIT Screening Tool	Feasibility will be measured as the percentage of eligible participants completing the FIT screening tool. Criterion for success: 65% of all eligible participants complete the FIT screening tool.	Up to 6 months
Feasibility of FIT Specimens Adequate for Lab Processing	Feasibility will be measured as the percentage of FIT specimens collected from participants that are adequate for processing. Criterion for success: 95% of all FIT specimens are adequate for lab processing.	Up to 6 months
Feasibility of Participants with Positive FIT Results Who Comply with Follow-up for Colonoscopy	Feasibility will be measured as the percentage of participants with positive FIT results who comply with the necessary follow-up for colonoscopy. Criterion for success: 85% of all participants with positive FIT results comply with necessary follow up for colonoscopy.	Up to 6 months
Acceptability of Participants Who Feel FIT is an Acceptable Method of Screening	Acceptability will be measured as the percentage of participants who feel the FIT is an acceptable method of screening. Criterion for success: 90% of participants who complete the FIT find it to be an acceptable method of screening.	Up to 6 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Florida
• Investigators: Principal Investigator: Erin Kobetz-Kerman, Phd, MPH, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2016
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): November 19, 2019

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• 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: 20150905; NCI-2023-00172 (Registry Identifier: NCI Clinical Trials Reporting Program (NCI CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No