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Addressing Colorectal Cancer in South Florida Firefighters

Primary Purpose

Colorectal Cancer, CRC

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Immunochemical Test
Septin9 Test
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: For this study, participation is open to active and retired firefighters: ≥ 40 and ≤ 65 years of age, who work or worked in Florida Fire and Rescue departments and 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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FIT Group

Septin9 Test Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2023
Last Updated
July 27, 2023
Sponsor
University of Miami
Collaborators
Florida
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1. Study Identification

Unique Protocol Identification Number
NCT05976282
Brief Title
Addressing Colorectal Cancer in South Florida Firefighters
Official Title
Addressing Colorectal Cancer in South Florida Firefighters
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
December 12, 2018 (Actual)
Study Completion Date
November 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Florida

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, CRC

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
646 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FIT Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Septin9 Test Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Fecal Immunochemical Test
Other Intervention Name(s)
FIT
Intervention Description
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
Intervention Name(s)
Septin9 Test
Other Intervention Name(s)
SEPT9
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of Participants Completing FIT Screening Tool
Description
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.
Time Frame
Up to 6 months
Title
Feasibility of FIT Specimens Adequate for Lab Processing
Description
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.
Time Frame
Up to 6 months
Title
Feasibility of Participants with Positive FIT Results Who Comply with Follow-up for Colonoscopy
Description
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.
Time Frame
Up to 6 months
Title
Acceptability of Participants Who Feel FIT is an Acceptable Method of Screening
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: For this study, participation is open to active and retired firefighters: ≥ 40 and ≤ 65 years of age, who work or worked in Florida Fire and Rescue departments and 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erin Kobetz-Kerman, Phd, MPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Addressing Colorectal Cancer in South Florida Firefighters

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