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

NCT ID: NCT06074536

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-06

Study Completion Date

2027-11-30

Brief Summary

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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

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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

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Colorectal Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

PREVENTION

Blinding Strategy

SINGLE

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

Study Groups

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Interventional arm

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.

Group Type EXPERIMENTAL

patient-centered approach training

Intervention Type PROCEDURE

face to face training of general practitioner of interventional arm

Control arm

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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patient-centered approach training

face to face training of general practitioner of interventional arm

Intervention Type PROCEDURE

Eligibility Criteria

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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


\- ✓ 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
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CNGE Conseil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isabelle AUGER-AUBIN, Pr

Role: STUDY_CHAIR

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

Locations

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Cabinet de groupe pluriprofessionnel

Soisy-sous-Montmorency, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle AUGER-AUBIN, Pr

Role: CONTACT

06 83 28 26 36

Josselin LeBel, Dr

Role: CONTACT

33 (0)1 57 27 74 64

Facility Contacts

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Isabelle AUGER-AUBIN, Pr

Role: primary

06 83 28 26 36

Jade RAYNAL, Dr

Role: backup

Other Identifiers

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IDRCB:2023-A00859-36

Identifier Type: OTHER

Identifier Source: secondary_id

CNGE-2021-04

Identifier Type: -

Identifier Source: org_study_id

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