General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening

Colorectal Cancer Clinical Trial

Official title:

Effect of Eligible Patients Paper-based Reminder for General Practitioners on Colorectal Cancer Screening Participation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01364454
• Other study ID #: DUERMG
• Status: Completed
• Phase: Phase 0
• First received: May 31, 2011
• Last updated: August 18, 2016
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: August 2016
• Source: Paris 12 Val de Marne University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence that it reduces mortality from CRC and that it's cost-effective. In France, there is a national CRC screening programme inviting people aged 50-74 years by mail to consult their General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two years. Participation is a key factor for the screening programs success. High levels of screening uptake and the continued participation to regular screening must be achieved and maintained in the targeted population if the enormous potential of CRC screening is to be realised. Screening rates of various international programs vary widely (20-52%) and the participation is insufficient in the most settings. Therefore, a better understanding of facilitating and hindering factors of patient participation can guide interventions to improve CRC screening rates. They include patients and physicians' factors. One issue is about GPs practice. GP involvement has been shown to improve the participation in the CRC screening. This study aims to assess the effectiveness of an intervention targeting GPs to increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in providing every four months to the experimental group a list of their patients who are eligible but did not proceed yet to the screening. In both groups, patient participation in the screening will be measured at the end of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8140
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

1. General Practitioner (GP)

• exercising in the Val de Marne (French department of the suburb of Paris)

• volunteered to participate at the study

2. Patient

• living in the Val de Marne (French department of the suburb of Paris)

• having declared a 'preferred GP' exercising in the Val de Marne to the main statutory health insurance scheme ("régime général")

• being eligible for colorectal cancer screening (aged 50 to 74 years, not excluded and having not proceed yet to the screening)

• having consulted his 'preferred GP', whatever the reason, during the study period

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Eligible patients' paper-based reminder
Providing to the general practitioners every four months a list of their patients who are eligible for colorectal cancer screening but did not proceed yet and were not excluded for medical reason

Locations

Country	Name	City	State
France	Département Universitaire d'Enseignement et de Recherche en Médecine Générale	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Paris 12 Val de Marne University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's participation to colorectal cancer screening program	Patient's status with colorectal cancer screening program to 15th june 2011 with two modalities; Update: completion of Faecal Occult Blood test or exclusion for medical reason within the duration of the study (The medical exclusions of the program are a personal or family history of Colorectal cancer, Crohn's disease, hemorrhagic rectocolitis, or hereditary nonpolyposis colorectal cancer, a colonoscopy undergone in the 5 previous years or a Fecal Occult Blood test undergone in the 2 previous years); Not update	1 year	No