Colorectal Cancer ScreeningFACELENCT06074536
Impact of Training Patient-centered Approach on Shared Decision in Colorectal Cancer Screening
A study testing patient-centered approach training in people with Colorectal Cancer Screening, run by CNGE Conseil at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- patient-centered approach training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2024to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 20Show fewer
- ✓ 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Cabinet de groupe pluriprofessionnel
Soisy-sous-Montmorency, 95230
Isabelle AUGER-AUBIN, Pr, 06 83 28 26 36, isabelle.auger-aubin@u-paris.fr
Jade RAYNAL, Dr, drjaderaynal@gmail.com
About this study
Official title: Impact of Training in the Patient-centered Approach on Shared Decision-making in the Colorectal Cancer Screening: a Cluster Randomized Trial
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).
Read the 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.
- Conditions
- Colorectal Cancer Screening
- Being tested
- patient-centered approach training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-centered approach trainingProcedure or surgery
face to face training of general practitioner of interventional arm
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | 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. Receives: Procedure: patient-centered approach training |
| Control arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 to 8 months after after patient nclusion (carrying out the screening test)
Secondary outcomes (3)
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,
Measured: 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
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.
Measured: 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
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
Measured: Data collected immediately after the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start6 Mar 2024
- Primary completion6 May 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient-centered face-to-face training for General Practitioners on implementation of a shared decision
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNGE Conseil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle AUGER-AUBIN, Pr, Study chair, cabinet de groupe pluriprofessionnel 40 rue Carnot 95230 Soisy-Sous-Montmorency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06074536
- Sponsor's protocol ID
- CNGE-2021-04
- Other IDs
- IDRCB:2023-A00859-36
- Acronym
- FACELE
- Status last verified
- Feb 2026
- First submitted
- 21 Sep 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Training in the Patient-centered Approach on Shared Decision-making in the Colorectal Cancer Screening: a Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT06074536
- Acronym / sponsor ID
- FACELE / CNGE-2021-04
- Conditions
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- CNGE ConseilUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 6 May 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patient-centered face-to-face training for General Practitioners on implementation of a shared decision
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Procedure: patient-centered approach trainingThe 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. |
| Control arm | No intervention | –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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-centered approach trainingface to face training of general practitioner of interventional arm | Procedure or surgery | Interventional arm |
Primary outcome
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
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
3 secondary outcomes
Evaluate the effect of training on the CRC screening rate
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
Confronting the shared decision made by the patient regarding the completion of CRC screening
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
Explore understanding of the shared decision process among general practitioners and patients
Time frame: Data collected immediately after the inclusion visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle AUGER-AUBIN, Pr study chair
cabinet de groupe pluriprofessionnel 40 rue Carnot 95230 Soisy-Sous-Montmorency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient-centered approach training in people with Colorectal Cancer Screening, run by CNGE Conseil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle AUGER-AUBIN, Pr (06 83 28 26 36, isabelle.auger-aubin@u-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 6 to 8 months after after patient nclusion (carrying out the screening test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.