Clinical trial NCT06074536: Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening
Official title: Impact of Training in the Patient-centered Approach on Shared Decision-making in the Colorectal Cancer Screening: a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer Screening
Lead sponsor: CNGE Conseil
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 400
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-centered face-to-face training for General Practitioners on implementation of a shared decision
Primary purpose: PREVENTION

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 to 8 months after after patient nclusion (carrying out the screening test)
Secondary outcomes:
measure: Evaluate the effect of training on the CRC screening rate
timeFrame: 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
measure: Confronting the shared decision made by the patient regarding the completion of CRC screening
timeFrame: 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
measure: Explore understanding of the shared decision process among general practitioners and patients
timeFrame: Data collected immediately after the inclusion visit
Other outcomes:
Locations:
city: Soisy-Sous-Montmorency
country: France
facility: Cabinet de groupe pluriprofessionnel
Study officials:
affiliation: cabinet de groupe pluriprofessionnel 40 rue Carnot 95230 Soisy-Sous-Montmorency
name: Isabelle AUGER-AUBIN, Pr
role: STUDY_CHAIR
References: