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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06074536
Acronym
FACELE
Enrollment
400
Registered
2023-10-10
Start date
2024-03-06
Completion date
2027-11-30
Last updated
2026-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Screening

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.

Interventions

PROCEDUREpatient-centered approach training

face to face training of general practitioner of interventional arm

Sponsors

CNGE Conseil
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

Patient not informed of the randomization arm to which their general practitioner enrolled

Intervention model description

Patient-centered face-to-face training for General Practitioners on implementation of a shared decision

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 French6 to 8 months after after patient nclusion (carrying out the screening test)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

Secondary

MeasureTime frameDescription
Evaluate the effect of training on the CRC screening rateMeasurements taken 6 months after the last patient was included in the trial, i.e. no later than 18 months after the start of the trialparticipation rate in organized CRC screening at individual level. Measurements taken 6 months after the last patient was included in the trial,
Confronting the shared decision made by the patient regarding the completion of CRC screeningMeasurements taken 6 months after the last patient was included in the trial, i.e. no later than 18 months after the start of the trialParticipation 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.
Explore understanding of the shared decision process among general practitioners and patientsData collected immediately after the inclusion visitProportion (IC95%) of included patients with a SURE test result of less than 4

Countries

France

Contacts

CONTACTIsabelle AUGER-AUBIN, Pr
isabelle.auger-aubin@u-paris.fr06 83 28 26 36
CONTACTJosselin LeBel, Dr
josselin.lebel@u-paris.fr33 (0)1 57 27 74 64
STUDY_CHAIRIsabelle AUGER-AUBIN, Pr

cabinet de groupe pluriprofessionnel 40 rue Carnot 95230 Soisy-Sous-Montmorency

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026