search
Back to results

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

Primary Purpose

Colorectal Cancer Screening

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
patient-centered approach training
Sponsored by
CNGE Conseil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer Screening

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Exclusion 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) 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Interventional arm

    Control arm

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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,
    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.
    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

    Full Information

    First Posted
    September 21, 2023
    Last Updated
    October 6, 2023
    Sponsor
    CNGE Conseil
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06074536
    Brief Title
    Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening
    Acronym
    FACELE
    Official Title
    Impact of Training in the Patient-centered Approach on Shared Decision-making in the Colorectal Cancer Screening: a Cluster Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    August 1, 2025 (Anticipated)
    Study Completion Date
    August 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CNGE Conseil

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer Screening

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patient-centered face-to-face training for General Practitioners on implementation of a shared decision
    Masking
    Participant
    Masking Description
    Patient not informed of the randomization arm to which their general practitioner enrolled
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interventional arm
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Control arm
    Arm Type
    No Intervention
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    patient-centered approach training
    Intervention Description
    face to face training of general practitioner of interventional arm
    Primary Outcome Measure Information:
    Title
    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
    Description
    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
    6 to 8 months after after patient nclusion (carrying out the screening test)
    Secondary Outcome Measure Information:
    Title
    Evaluate the effect of training on the CRC screening rate
    Description
    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
    Title
    Confronting the shared decision made by the patient regarding the completion of CRC screening
    Description
    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
    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
    Title
    Explore understanding of the shared decision process among general practitioners and patients
    Description
    Proportion (IC95%) of included patients with a SURE test result of less than 4
    Time Frame
    Data collected immediately after the inclusion visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    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 Exclusion 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) 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Isabelle AUGER-AUBIN, Pr
    Phone
    06 83 28 26 36
    Email
    isabelle.auger-aubin@u-paris.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Josselin LeBel, Dr
    Phone
    33 (0)1 57 27 74 64
    Email
    josselin.lebel@u-paris.fr

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs