General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
Eligible patients' paper-based reminder
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Cancer Screening, Faecal Occult Blood test, General Practitioners Involvement, Patient's Participation, Reminder
Eligibility Criteria
Inclusion Criteria:
General Practitioner (GP)
- exercising in the Val de Marne (French department of the suburb of Paris)
- volunteered to participate at the study
Patient
- living in the Val de Marne (French department of the suburb of Paris)
- having declared a 'preferred GP' exercising in the Val de Marne to the main statutory health insurance scheme ("régime général")
- being eligible for colorectal cancer screening (aged 50 to 74 years, not excluded and having not proceed yet to the screening)
- having consulted his 'preferred GP', whatever the reason, during the study period
Exclusion Criteria:
Sites / Locations
- Département Universitaire d'Enseignement et de Recherche en Médecine Générale
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Eligible patients' paper-based reminder
Control group
Arm Description
Outcomes
Primary Outcome Measures
Patient's participation to colorectal cancer screening program
Patient's status with colorectal cancer screening program to 15th june 2011 with two modalities
Update: completion of Faecal Occult Blood test or exclusion for medical reason within the duration of the study (The medical exclusions of the program are a personal or family history of Colorectal cancer, Crohn's disease, hemorrhagic rectocolitis, or hereditary nonpolyposis colorectal cancer, a colonoscopy undergone in the 5 previous years or a Fecal Occult Blood test undergone in the 2 previous years)
Not update
Secondary Outcome Measures
Full Information
NCT ID
NCT01364454
First Posted
May 31, 2011
Last Updated
August 18, 2016
Sponsor
Paris 12 Val de Marne University
1. Study Identification
Unique Protocol Identification Number
NCT01364454
Brief Title
General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening
Official Title
Effect of Eligible Patients Paper-based Reminder for General Practitioners on Colorectal Cancer Screening Participation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paris 12 Val de Marne University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence that it reduces mortality from CRC and that it's cost-effective. In France, there is a national CRC screening programme inviting people aged 50-74 years by mail to consult their General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two years. Participation is a key factor for the screening programs success. High levels of screening uptake and the continued participation to regular screening must be achieved and maintained in the targeted population if the enormous potential of CRC screening is to be realised. Screening rates of various international programs vary widely (20-52%) and the participation is insufficient in the most settings. Therefore, a better understanding of facilitating and hindering factors of patient participation can guide interventions to improve CRC screening rates. They include patients and physicians' factors. One issue is about GPs practice. GP involvement has been shown to improve the participation in the CRC screening. This study aims to assess the effectiveness of an intervention targeting GPs to increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in providing every four months to the experimental group a list of their patients who are eligible but did not proceed yet to the screening. In both groups, patient participation in the screening will be measured at the end of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer Screening, Faecal Occult Blood test, General Practitioners Involvement, Patient's Participation, Reminder
7. Study Design
Primary Purpose
Screening
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eligible patients' paper-based reminder
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Eligible patients' paper-based reminder
Intervention Description
Providing to the general practitioners every four months a list of their patients who are eligible for colorectal cancer screening but did not proceed yet and were not excluded for medical reason
Primary Outcome Measure Information:
Title
Patient's participation to colorectal cancer screening program
Description
Patient's status with colorectal cancer screening program to 15th june 2011 with two modalities
Update: completion of Faecal Occult Blood test or exclusion for medical reason within the duration of the study (The medical exclusions of the program are a personal or family history of Colorectal cancer, Crohn's disease, hemorrhagic rectocolitis, or hereditary nonpolyposis colorectal cancer, a colonoscopy undergone in the 5 previous years or a Fecal Occult Blood test undergone in the 2 previous years)
Not update
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
General Practitioner (GP)
exercising in the Val de Marne (French department of the suburb of Paris)
volunteered to participate at the study
Patient
living in the Val de Marne (French department of the suburb of Paris)
having declared a 'preferred GP' exercising in the Val de Marne to the main statutory health insurance scheme ("régime général")
being eligible for colorectal cancer screening (aged 50 to 74 years, not excluded and having not proceed yet to the screening)
having consulted his 'preferred GP', whatever the reason, during the study period
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Le Breton, MD, MPH
Organizational Affiliation
DUERMG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département Universitaire d'Enseignement et de Recherche en Médecine Générale
City
Créteil
ZIP/Postal Code
94000
Country
France
12. IPD Sharing Statement
Learn more about this trial
General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening
We'll reach out to this number within 24 hrs