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General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01364454
First Posted: June 2, 2011
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Julien Le Breton, Paris 12 Val de Marne University
  Purpose
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.

Condition Intervention Phase
Colorectal Cancer Other: Eligible patients' paper-based reminder Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of Eligible Patients Paper-based Reminder for General Practitioners on Colorectal Cancer Screening Participation

Resource links provided by NLM:


Further study details as provided by Julien Le Breton, Paris 12 Val de Marne University:

Primary Outcome Measures:
  • 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. 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)
    2. Not update


Enrollment: 8140
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eligible patients' paper-based reminder Other: Eligible patients' paper-based reminder
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
No Intervention: Control group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. General Practitioner (GP)

    • exercising in the Val de Marne (French department of the suburb of Paris)
    • volunteered to participate at the study
  2. 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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01364454


Locations
France
Département Universitaire d'Enseignement et de Recherche en Médecine Générale
Créteil, France, 94000
Sponsors and Collaborators
Paris 12 Val de Marne University
Investigators
Principal Investigator: Julien Le Breton, MD, MPH DUERMG
  More Information

Responsible Party: Julien Le Breton, MD, MPH, Paris 12 Val de Marne University
ClinicalTrials.gov Identifier: NCT01364454     History of Changes
Other Study ID Numbers: DUERMG
First Submitted: May 31, 2011
First Posted: June 2, 2011
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Julien Le Breton, Paris 12 Val de Marne University:
Colorectal Cancer Screening
Faecal Occult Blood test
General Practitioners Involvement
Patient's Participation
Reminder

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases