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Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer (IDLN)

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ClinicalTrials.gov Identifier: NCT02515344
Recruitment Status : Completed
First Posted : August 4, 2015
Last Update Posted : September 16, 2016
Sponsor:
Collaborators:
Public Health Insurance
Université de Nantes
Organisms in charge of local cancer screening programs - France
Local Cancer Registry - France
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
Objective : to demonstrate that providing to GPs a list of their patients who are not compliant to colorectal cancer screening will 1) enhance patient participation to screening, and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design : Randomised controlled study, 3 parallel arms. Enrollment: GPs allocated in the 3 groups of the study will be all GPs 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average) and 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services). Patients will be eligible to the study depending on their eligibility to the Faecal Occult Blood Test for colorectal cancer screening : 1) they should be older than 50 and younger than 74; 2) they should not have a personal history of colorectal cancer (or history of adenoma bigger than 1 cm) nor a family history of colorectal cancer. Main outcomes measures : Patient participation to colorectal cancer screening, and number of cancers screened in (versus diagnosed outside) the screening procedure.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Providing a list of patients not compliant with CRC sreening Other: Providing general information about CRC sreening Not Applicable

Detailed Description:

Background:

Participation rate for colorectal cancer screening in France is 39%. In a Cochrane review, patient participation rates to colorectal cancer screening varies from 30 to 60%. Policy makers usually consider that these participation rates should be higher, based on the premise that the impact of the screening mainly depends on patient participation. In France, patients at average risk of colorectal cancer are eligible to the Faecal Occult Blood Test for colorectal cancer screening if: 1) they are older than 50 and younger than 74; 2) they have no personal history of colorectal cancer (or history of adenoma bigger than 1 cm) and no family history of colorectal cancer.

Objective:

To demonstrate that providing to GPs a list of their patients who are not compliant to colorectal cancer screening will 1) enhance patient participation to screening, and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design : Randomised controlled study, 3 parallel arms.

Design:

Randomized controlled study. 3 parallel arms.

Setting:

Primary care setting in France.

Enrollment:

In this study, the intervention will focus on the GP. The statistical unit for the results analysis will be the GP. GPs allocated in the 3 groups of the study will be all GPs 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average) and 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).

Intervention:

GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive the corresponding information.

Randomization:

3 groups : (A) GPs will receive a list of the patients who are not compliant to colorectal cancer screening, (B) GPs will receive a document providing general information on colorectal cancer screening, (C) GPs will not receive any specific document (they continue regular practice).

Primary outcome measure: Patient participation to colorectal cancer screening Secondary Outcome Measures: number of cancers screened in (versus diagnosed outside) the screening procedure.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48649 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer: Randomised Study Measuring the Impact on Participation
Study Start Date : August 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A: nominative list

Providing a list of patients not compliant with CRC sreening

General Practitioners allocated to the intervention group (A) will receive:

  • a nominative list of their patients who were not compliant to colorectal cancer screening.
  • a document providing general information about colorectal cancer screening
Other: Providing a list of patients not compliant with CRC sreening
GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive this information.

Other: Providing general information about CRC sreening
Active Comparator: B: general information

Providing general information about CRC screening

General Practitioners allocated to group (B) will receive:

- a document providing general information about colorectal cancer screening (but will not receive the nominative list of patients non compliant to colorectal cancer screening)

Other: Providing general information about CRC sreening
No Intervention: C: usual practice
General Practitioners allocated to group (C) will not receive any information (as in usual practice)



Primary Outcome Measures :
  1. Patient participation rate to colorectal cancer screening [ Time Frame: 12 months after starting date of the study ]

Secondary Outcome Measures :
  1. Number of cancers screened in (versus diagnosed outside) the screening procedure. [ Time Frame: 12 months after starting date of the study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

In this study, the statistical unit is the GP.

Inclusion Criteria:

GPs allocated in the 3 groups of the study will be all GPs

  • 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average)
  • 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).

Exclusion Criteria:

  • GPs who have less than 100 patients in their patient list
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02515344    
Other Study ID Numbers: RC12_0497
First Posted: August 4, 2015    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Keywords provided by Nantes University Hospital:
Patients
early detection of cancer
patient compliance
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases