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

Colorectal Cancer Clinical Trial

— Pagedocc2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01279330
• Other study ID #: PAGEDOCC2
• Status: Recruiting
• Phase: N/A
• First received: January 18, 2011
• Last updated: January 18, 2011
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: September 2010
• Source: University of Paris 5 - Rene Descartes
• Contact: Serge Gilberg
• Phone: 01 44 41 23 63
• Email: gilberg[@]parisdescartes.fr
• Is FDA regulated: No
• Health authority: France : Commission Nationale des informatiques et des Libertés (CNIL)
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1569
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Co-signed Letter
Patients receive a personalized stimulus letter co-signed by their general practitioner and the medical coordinator of ADECA.
• Control
No intervention (Patients receive by mail the materials needed for stool samples).

Locations

Country	Name	City	State
France	Université Paris Descartes	Paris	Ile de France

Sponsors (4)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	Adeca 75, Hotel Dieu Hospital, Société de Formation Thérapeutique du Généraliste

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Delays from receipt of the letter and the completion of the test.		7 months	No
Secondary	Proportion of uninterpretable test.		7 months	No