Back to resultsPilot Study in a Company in Maine-et-Loire to Evaluate the Feasibility, Acceptability, and Impact on the Participation Rate of Awareness of Colorectal Cancer Screening by Occupational Health Teams
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
awareness campaign
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- The study population is made up of the employees of the CHU d'Angers included in the target population of organized colorectal cancer screening in the Maine-et-Loire so employees aged 50 and over.
Exclusion Criteria:
- The criteria for non-inclusion are those of organized screening for colorectal cancer taking into account the active population:
- Age <50 years and> 67 years
- Personal or family history of polyps or colorectal cancer
- Personal history of intestinal disease already undergoing colonoscopy surveillance (chronic inflammatory bowel disease, HNPCC syndrome, familial adenomatous polyposis)
- Known genetic disease with risk of developing colorectal cancer.
Sites / Locations
- Santé au Travail CHU AngersRecruiting
Outcomes
Primary Outcome Measures
variation of the rate of participation in colorectal cancer screening
effective variation (after versus prior to awareness raising) of the overall rate of participation in colorectal cancer screening among employees of the company after 2 years.
Secondary Outcome Measures
Full Information
NCT ID
NCT03458949
First Posted
March 2, 2018
Last Updated
June 29, 2018
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03458949
Brief Title
Pilot Study in a Company in Maine-et-Loire to Evaluate the Feasibility, Acceptability, and Impact on the Participation Rate of Awareness of Colorectal Cancer Screening by Occupational Health Teams
Official Title
Pilot Study in a Company in Maine-et-Loire to Evaluate the Feasibility, Acceptability, and Impact on the Participation Rate of Awareness of Colorectal Cancer Screening by Occupational Health Teams
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main objective of this pilot study is to implement an awareness campaign for colorectal cancer screening in the workplace, in partnership with the staff of the occupational health service of one of the largest companies in Maine-Loire , and to evaluate the impact of this action on the participation rate of colorectal cancer screening among employees.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
awareness campaign
Intervention Description
awareness campaign for colorectal cancer screening in the workplace
Primary Outcome Measure Information:
Title
variation of the rate of participation in colorectal cancer screening
Description
effective variation (after versus prior to awareness raising) of the overall rate of participation in colorectal cancer screening among employees of the company after 2 years.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The study population is made up of the employees of the CHU d'Angers included in the target population of organized colorectal cancer screening in the Maine-et-Loire so employees aged 50 and over.
Exclusion Criteria:
The criteria for non-inclusion are those of organized screening for colorectal cancer taking into account the active population:
Age <50 years and> 67 years
Personal or family history of polyps or colorectal cancer
Personal history of intestinal disease already undergoing colonoscopy surveillance (chronic inflammatory bowel disease, HNPCC syndrome, familial adenomatous polyposis)
Known genetic disease with risk of developing colorectal cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François-Xavier Caroli-Bosc, MDPhD
Phone
+33 2 41 35 60 54
Email
FX.Caroli-Bosc@chu-angers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François-Xavier Caroli-Bosc, MDPhD
Organizational Affiliation
University Hospital, Angers
Official's Role
Principal Investigator
Facility Information:
Facility Name
Santé au Travail CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierrre RUCAY, MD
12. IPD Sharing Statement
Learn more about this trial
Pilot Study in a Company in Maine-et-Loire to Evaluate the Feasibility, Acceptability, and Impact on the Participation Rate of Awareness of Colorectal Cancer Screening by Occupational Health Teams
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