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

Colorectal Cancer Screening Clinical Trial

— FACELE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06074536
• Other study ID #: CNGE-2021-04
• Secondary ID: IDRCB:2023-A0085
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2024
• Est. completion date: November 30, 2025

Study information

• Verified date: March 2024
• Source: CNGE Conseil
• Contact: Isabelle AUGER-AUBIN, Pr
• Phone: 06 83 28 26 36
• Email: isabelle.auger-aubin[@]u-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 30, 2025
• Est. primary completion date: November 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Procedure:
• patient-centered approach training
face to face training of general practitioner of interventional arm

Locations

Country	Name	City	State
France	Cabinet de groupe pluriprofessionnel	Soisy-Sous-Montmorency

Sponsors (1)

Lead Sponsor	Collaborator
CNGE Conseil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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