Cabinet de groupe pluriprofessionnel
Soisy-sous-Montmorency, 95230, France
Location status: Recruiting
Location contact
Isabelle AUGER-AUBIN, Pr
CONTACT
Jade RAYNAL, Dr
CONTACT
NCT Number: NCT06074536
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).
Interested in participating?
Request Info50 year–74 year
All sexes
Interventional
Not applicable
Soisy-sous-Montmorency, 95230, France
Location status: Recruiting
Isabelle AUGER-AUBIN, Pr
CONTACT
Jade RAYNAL, Dr
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
✓ Consulting their attending clinician for the duration of the study,
Non inclusion Criteria:
face to face training of general practitioner of interventional arm
Time frame: 6 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
Time frame: 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
participation rate in organized CRC screening at individual level. Measurements taken 6 months after the last patient was included in the trial,
Time frame: 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
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.
Time frame: Data collected immediately after the inclusion visit
Proportion (IC95%) of included patients with a SURE test result of less than 4
Contact information is provided by the study sponsor or research team.
Isabelle AUGER-AUBIN, Pr
CONTACT
Josselin LeBel, Dr
CONTACT
CNGE Conseil
Other
Impact of Training in the Patient-centered Approach on Shared Decision-making in the Colorectal Cancer Screening: a Cluster Randomized Trial
Acronym: FACELE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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