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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Paris 5 - Rene Descartes.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
ADECA 75
Société de Formation Thérapeutique du Généraliste
Hotel Dieu Hospital
Information provided by:
University of Paris 5 - Rene Descartes
ClinicalTrials.gov Identifier:
NCT01279278
First received: January 18, 2011
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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 Intervention
Colorectal Cancer
 Other: Co-signed letter
Other: Classical Letter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Paris 5 - Rene Descartes:

Primary Outcome Measures:
  • Completion of Fecal Occult Blod Test [ Time Frame: 7 months ] [ Designated as safety issue: No ]
    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:
  • Measure the impact of co-signing on deadline for completion of the test after the mailing. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • Compare the proportion of uninterpretable tests. [ Time Frame: 7 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2700
Study Start Date: September 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01279278

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

Locations
France
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

No publications provided

Responsible Party: Pr Serge Gilberg, Université Paris Descartes - Département de Médecine Générale
ClinicalTrials.gov Identifier: NCT01279278     History of Changes
Other Study ID Numbers: PAGEDOCC1
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: France: Commission Nationale des informatiques et des Libertés (CNIL)

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

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

ClinicalTrials.gov processed this record on May 19, 2013