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Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? (Pagedocc1)

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.
ClinicalTrials.gov Identifier: NCT01279278
Recruitment Status : Unknown
Verified September 2010 by University of Paris 5 - Rene Descartes.
Recruitment status was:  Recruiting
First Posted : January 19, 2011
Last Update Posted : January 19, 2011
Information provided by:

Study Description
Brief Summary:
The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).

Condition or disease Intervention/treatment
Colorectal Cancer Other: Co-signed letter Other: Classical Letter

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.
Study Start Date : September 2010
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control Other: Classical Letter
Patients receive classical letter signed by the coordinator doctor of ADECA
Experimental: Co-signed Letter Other: Co-signed letter
Patients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA.

Outcome Measures

Primary Outcome Measures :
  1. Completion of Fecal Occult Blod Test [ Time Frame: 7 months ]
    Increased number of patients who completed the test for faecal occult blood following the first solicitation with the letter co-signed by general practitioner, compared with the conventional solicition(including replies exclusions).

Secondary Outcome Measures :
  1. Measure the impact of co-signing on deadline for completion of the test after the mailing. [ Time Frame: 7 months ]
  2. Compare the proportion of uninterpretable tests. [ Time Frame: 7 months ]
  3. Compare the rate of completion of colonoscopy after a positive test (information received by ADECA in the follow-up), according to the specifications. [ Time Frame: 7 months ]

Eligibility Criteria

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

Inclusion Criteria:

  • Aged : 50 to 74 years.
  • Not having ever been invited to participate in colorectal screening.

Exclusion Criteria:

  • Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).
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): NCT01279278

Contact: Serge Gilberg 01 44 41 23 63 gilberg@parisdescartes.fr

Université Paris Descartes Recruiting
Paris, Ile de France, France, 75014
Contact: Barthe    01 44 41 23 63    juliette.barthe@gmail.com   
Sponsors and Collaborators
University of Paris 5 - Rene Descartes
Adeca 75
Société de Formation Thérapeutique du Généraliste
Hotel Dieu Hospital
More Information

Responsible Party: Pr Serge Gilberg, Université Paris Descartes - Département de Médecine Générale
ClinicalTrials.gov Identifier: NCT01279278     History of Changes
Other Study ID Numbers: PAGEDOCC1
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: September 2010

Keywords provided by University of Paris 5 - Rene Descartes:
Colorectal Cancer
General Practitioner
Fecal Occult Blood Tests

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