Impact of a Proactive Strategy of General Practitioners on CRC Screening (DECORE)

September 10, 2025 updated by: University Hospital, Bordeaux

Impact of a Proactive Strategy of General Practitioners on CRC Screening: a Registry-based Cluster-based Randomized Controlled Trial

In this registry-based cluster randomized controlled trial, we will assess the impact of a proactive strategy of general practitioners (GP) who will systematically provide screening kits of colorectal cancer (CRC) to all patients of even age (50, 52, 54...up to 74 years) versus usual practice where the eligible population receive an invitation letter to visit the general practitioner and receive the screening kit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Colorectal cancer is one of the leading causes of cancer and death in France in both men and women. The generalized screening rate is about 30% in France, far from the expected 65%, despite the fact that screening is free and a letter of invitation is sent to the individual's home, and despite the financial incentives provided to the practitioner. Different studies have looked for the causes of non-implementation by the individual: negligence, "dirty"; forgetfulness, and the practitioner: organizational problem, communication problem. A few intervention studies have been carried out with little success: sending the invitation to the individual's home, sending a letter of reminder, sending a letter of general information on screening to the practitioner, sending the list of patients who have not taken the test to the practitioner allows for a few percent improvement in screening. In this registry-based cluster randomized controlled trial, we will assess the impact of a proactive strategy of general practitioners who will systematically provide screening kits of colorectal cancer to all patients of even age (50, 52, 54 years...up to 74 years) versus usual practice where the eligible population receive an invitation letter to visit the general practitioner and receive the screening kit. The screening rate will be calculated for each arm at the end of the 2-year study with data from the health insurance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patient between 50 and 74 years old

Description

inclusion criteria:

- medical practices in Aquitaine region and their visiting patients eligible for colorectal cancer screening individuals aged between 50 and 74 years at intermediate risk of colorectal cancer).

Exclusion criteria:

  • medical practices with less than five individual eligible for colorectal cancer screening.
  • visiting patients aged less than 50 years or more than 74 years or at high or very high risk of colorectal cancer.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Systematic provision of screening tests by GPs
The general practitioner systematically delivers the screening kit with justification and modalities of realization at an even age between 50 and 74 years to the patient who comes to consult for whatever reason, who is at intermediate risk of colorectal cancer and who falls under the generalized screening. The practitioner is helped in his approach by an initial training in the identification of the age, delivery of a poster, a study sheet, stickers and goodies, sending a quarterly letter on the progress of the study and contact with the coordination team.
Behavioral: Colorectal cancer screening test
delivery of colorectal cancer screening test by GP
Delivery of screening test according to GP's usual practice
the GP will issue the CRC screening kit in accordance with his/her usual practice.
Behavioral: Colorectal cancer screening test
delivery of colorectal cancer screening test by GP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participation rate in CRC screening
Time Frame: 2 years after the start of protocol
The primary endpoint of this trial is the rate of participation rate in CRC screening in the eligible patient population grouped with or without intervention. This criterion will be measured by retrospective analysis of retrospective analysis of National Health Data System data.
2 years after the start of protocol

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Positive test results
Time Frame: 2 years after the start of protocol
Rate of patients with positive test results
2 years after the start of protocol
Positive test at an early stage
Time Frame: 2 years after the start of protocol
rate of patients tested positive at an early stage
2 years after the start of protocol
Positive test at a last stage
Time Frame: 2 years after the start of protocol
rate of patients testing positive at a late stage
2 years after the start of protocol

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2021/64

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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