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

January 18, 2011 updated by: University of Paris 5 - Rene Descartes

Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2700

Phase

  • Not Applicable

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

  • France
    • Ile de France
      • Paris, Ile de France, France, 75014

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:

  • 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).

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure the impact of co-signing on deadline for completion of the test after the mailing.
Time Frame: 7 months
7 months
Compare the proportion of uninterpretable tests.
Time Frame: 7 months
7 months
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
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 5 - Rene Descartes

Collaborators

Hotel Dieu Hospital
Société de Formation Thérapeutique du Généraliste
Adeca 75

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

September 1, 2010

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

January 18, 2011

First Submitted That Met QC Criteria

January 18, 2011

First Posted (Estimate)

January 19, 2011

Study Record Updates

Last Update Posted (Estimate)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 18, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAGEDOCC1

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.

Subscribe