- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01364454
General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening
August 18, 2016 updated by: Julien Le Breton, Paris 12 Val de Marne University
Effect of Eligible Patients Paper-based Reminder for General Practitioners on Colorectal Cancer Screening Participation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8140
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Créteil, France, 94000
- Département Universitaire d'Enseignement et de Recherche en Médecine Générale
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
|
|
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Experimental: Eligible patients' paper-based reminder
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient's participation to colorectal cancer screening program
Time Frame: 1 year
|
Patient's status with colorectal cancer screening program to 15th june 2011 with two modalities
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julien Le Breton, MD, MPH, DUERMG
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
May 31, 2011
First Submitted That Met QC Criteria
June 1, 2011
First Posted (Estimate)
June 2, 2011
Study Record Updates
Last Update Posted (Estimate)
August 19, 2016
Last Update Submitted That Met QC Criteria
August 18, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DUERMG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.