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

CNGE Conseil

Status: Enrolling

Conditions: Colorectal Cancer Screening

Treatments: Procedure: patient-centered approach training

Study type: Interventional

Funder types: Other

Identifiers

NCT06074536

CNGE-2021-04

IDRCB:2023-A00859-36 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Interventional arm

Experimental group

Description:

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.

Treatment:

Procedure: patient-centered approach training

Control arm

No Intervention group

Description:

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.