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Trial Title:
Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening
NCT ID:
NCT06074536
Condition:
Colorectal Cancer Screening
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Patient-centered face-to-face training for General Practitioners on implementation of a
shared decision
Primary purpose:
Prevention
Masking:
Single (Participant)
Masking description:
Patient not informed of the randomization arm to which their general practitioner
enrolled
Intervention:
Intervention type:
Procedure
Intervention name:
patient-centered approach training
Description:
face to face training of general practitioner of interventional arm
Arm group label:
Interventional arm
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.
Criteria for 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
Gender:
All
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cabinet de groupe pluriprofessionnel
Address:
City:
Soisy-Sous-Montmorency
Zip:
95230
Country:
France
Status:
Recruiting
Contact:
Last name:
Isabelle AUGER-AUBIN, Pr
Phone:
06 83 28 26 36
Email:
isabelle.auger-aubin@u-paris.fr
Contact backup:
Last name:
Jade RAYNAL, Dr
Email:
drjaderaynal@gmail.com
Start date:
March 6, 2024
Completion date:
November 30, 2025
Lead sponsor:
Agency:
CNGE Conseil
Agency class:
Other
Source:
CNGE Conseil
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06074536
