Addressing Colorectal Cancer in South Florida Firefighters

NCT ID: NCT05976282

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 646 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-15
• Study Completion Date: 2019-11-19

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.

Conditions

Colorectal Cancer; CRC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fecal Immunochemical Test

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Septin9 Test

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

FIT; SEPT9

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Florida

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Erin Kobetz-Kerman, PhD, MPH

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erin Kobetz-Kerman, Phd, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

NCI-2023-00172

Identifier Type: REGISTRY

Identifier Source: secondary_id

20150905

Identifier Type: -

Identifier Source: org_study_id