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

NCT06074536 | Recruiting

• 2 other identifiers: CNGE-2021-04IDRCB:2023-A00859-36
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer Screening

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  Data collected immediately after the inclusion visit

Study Arms (2)

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.

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.

Interventions

patient-centered approach training PROCEDURE

face to face training of general practitioner of interventional arm

Interventional arm

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• CNGE Conseil: lead

Study Sites (1)

Cabinet de groupe pluriprofessionnel

Soisy-sous-Montmorency, 95230, France

RECRUITING

Study Officials

• Isabelle AUGER-AUBIN, Pr

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

  STUDY CHAIR

Central Study Contacts

Isabelle AUGER-AUBIN, Pr

CONTACT

06 83 28 26 36; isabelle.auger-aubin@u-paris.fr

Josselin LeBel, Dr

CONTACT

33 (0)1 57 27 74 64; josselin.lebel@u-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient not informed of the randomization arm to which their general practitioner enrolled
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient-centered face-to-face training for General Practitioners on implementation of a shared decision

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 10, 2023
• Study Start: March 6, 2024
• Primary Completion (Estimated): May 6, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

FR (1)