Clinical trial NCT05976282: Addressing Colorectal Cancer in South Florida Firefighters
Official title: Addressing Colorectal Cancer in South Florida Firefighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
CRC
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Florida
First posted: 2023-08-04
Enrollment: 646
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Participants Completing FIT Screening Tool
timeFrame: Up to 6 months
measure: Feasibility of FIT Specimens Adequate for Lab Processing
timeFrame: Up to 6 months
measure: Feasibility of Participants with Positive FIT Results Who Comply with Follow-up for Colonoscopy
timeFrame: Up to 6 months
measure: Acceptability of Participants Who Feel FIT is an Acceptable Method of Screening
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Erin Kobetz-Kerman, Phd, MPH
role: PRINCIPAL_INVESTIGATOR
References: