Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? (Pagedocc2)

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 in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Control; Other: Co-signed Letter

• Study Type: Interventional
• Enrollment (Anticipated): 1569
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serge Gilberg; Phone Number: 01 44 41 23 63; Email: gilberg@parisdescartes.fr

Study Locations

• France
  • Ile de France
    • Paris, Ile de France, France, 75014
      • Recruiting
      • Université Paris Descartes
      • Contact: Barthe; Phone Number: 01 44 41 23 63; Email: juliette.barthe@gmail.com

Participation Criteria

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:

• Age : 50 to 74 years.
• Not having answered the first two solicitations of ADECA75 to participate in screening for colorectal cancer

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

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients receive by mail the materials needed for stool samples.	Other: Control; No intervention (Patients receive by mail the materials needed for stool samples).
Experimental: Co-signed Letter	Other: Co-signed Letter; Patients receive a personalized stimulus 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	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
Delays from receipt of the letter and the completion of the test.	7 months
Proportion of uninterpretable test.	7 months

Collaborators and Investigators

• Sponsor: University of Paris 5 - Rene Descartes
• Collaborators: Hotel Dieu Hospital; Société de Formation Thérapeutique du Généraliste; Adeca 75

Study record dates

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: Screening; Colorectal Cancer; General Practitioner; Fecal Occult Blood Tests
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PAGEDOCC2