Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening (FACELE)

Impact of Training in the Patient-centered Approach on Shared Decision-making in the Colorectal Cancer Screening: a Cluster Randomized Trial

The purpose of this study is to compare the effect of face-to-face training of general practitioners on the implementation of a shared decision (in the context of colorectal cancer screening), versus current practice (i.e. without training in the patient-centered approach).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Procedure: patient-centered approach training

Detailed Description

Colorectal cancer (CRC) affects 95% of cases of people aged over 50 years old with an average age of diagnosis of 71 years for men and 73 years for women with a higher prevalence in women. By the age of 75, 4 out of 100 men and 3 out of 100 women will have developed colorectal cancer.

In France, CRC screening is based on a guaiac faecal occult blood test in subjects at risk average, carried out every 2 years from 50 to 74 years old. In the event of a positive test, a colonoscopy should be performed. Participation in the programme colorectal cancer screening has been declining since 2016-2017.

The implementation of screening faces many barriers on the physian's side and/or on the patient's side. During of the last 2020-2021 screening campaign, only 6.1 million people took a screening test, which represented a participation rate of 28.9%, while it is commonly admitted that a screening rate >50% would be necessary to reduce CRC mortality.

Some barriers are specific to CRC screening. for patient, reluctance to carry out screening, analysis of stools, and fear of cancer. For the physian, the discomfort in approaching screening and the uncertainty of the relevance of the test for some patients. The know-how and quality of information and communication with patients is at the forefront.

Physian must adapt their communication to the possibilities understanding of the subject to explain, convince, and bring the patient to carry out screening. Active listening is a technique particularly suitable for adopting a person-centred approach making it possible to take into account the patient perspectives in order to arrive at a shared decision.

This most often involves helping and giving the patient the means to manage their problems, involving them in a prevention project (non-requesting patient) or supporting them and motivating them in their approach (requesting patient).

The hypothesize of this study is that training general practitioners in a patient-centered approach will enable the implementation of greater shared decision-making work with the patient during a CRC screening presentation consultation.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle AUGER-AUBIN, Pr; Phone Number: 06 83 28 26 36; Email: isabelle.auger-aubin@u-paris.fr
• Study Contact Backup: Name: Josselin LeBel, Dr; Phone Number: 33 (0)1 57 27 74 64; Email: josselin.lebel@u-paris.fr

Study Locations

• France
  • Soisy-sous-Montmorency, France, 95230
    • Recruiting
    • Cabinet de groupe pluriprofessionnel
    • Contact: Isabelle AUGER-AUBIN, Pr; Phone Number: 06 83 28 26 36; Email: isabelle.auger-aubin@u-paris.fr
    • Contact: Jade RAYNAL, Dr; Email: drjaderaynal@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged 50 to 74:
• Eligible for organized CRC screening,

• Having declared as attending clinician a general practitioner investigator of the study

  ✓ Consulting their attending clinician for the duration of the study,

• AND able and willing to comply with all trial requirements

Non inclusion Criteria:

- ✓ Screened for CRC less than 2 years ago

• Not eligible for organized CRC screening:

  • History of adenomas or CRC:

    - Family (1st degree)

  • Personal history of IBD:

    • Crohn's disease
    • Ulcerative colitis)

  • Hereditary predispositions:

    • Familial adenomatous polyposis
    • Hereditary non-polyposis colorectal cancer (Lynch syndrome)
• Patient with symptoms requiring colonoscopy
• Having a level of literacy that does not allow the completion of the self-questionnaire.
• Having an inability to give express consent.
• Being under guardianship, curatorship or having cognitive disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional arm; The recruited GPs will be randomized into 2 parallel groups (interventional and control). Following this randomization, the GPs from the interventional group will undergo face-to-face training to the patient-centered approach.	Procedure: patient-centered approach training; face to face training of general practitioner of interventional arm
No Intervention: Control arm; The GPs of the control group will take care the patient according to current screening recommendations and procedures organized by the colorectal cancer (CCR) mass screening.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Measurement of the achievement oh the shared decision shared decision making in CRC screening using the patient shared a self-decision-making questionnaire (SDM-Q9), validated in French	comparison of the mean of the SDM-Q9 between each arm of the study from 0 (weak shared decision) to 100 (strong shared decision). We will compare the average of the SDM-Q9 between each arm of the study	6 to 8 months after after patient nclusion (carrying out the screening test)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect of training on the CRC screening rate	participation rate in organized CRC screening at individual level. Measurements taken 6 months after the last patient was included in the trial,	Measurements taken 6 months after the last patient was included in the trial, i.e. no later than 18 months after the start of the trial
Confronting the shared decision made by the patient regarding the completion of CRC screening	Participation rate (IC95%) in CRC screening according to the patient's decision at the end of the initial consultation: wish to be screened, neutral, wish not to be screened.	Measurements taken 6 months after the last patient was included in the trial, i.e. no later than 18 months after the start of the trial
Explore understanding of the shared decision process among general practitioners and patients	Proportion (IC95%) of included patients with a SURE test result of less than 4	Data collected immediately after the inclusion visit

Collaborators and Investigators

• Sponsor: CNGE Conseil
• Investigators: Study Chair: Isabelle AUGER-AUBIN, Pr, cabinet de groupe pluriprofessionnel 40 rue Carnot 95230 Soisy-Sous-Montmorency

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2024
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CNGE-2021-04; IDRCB:2023-A00859-36 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No