General Practitioners and Participation Rate in ColoRectal Cancer Screening (AMDepCCR)

Improving the Participation Rate in ColoRectal Cancer Screening by Training General Practitioners in Motivational Interviewing

Colorectal cancer is the 2nd leading cause of cancer mortality in France. However this cancer is preventable in the majority of cases by early detection of adenomas.

In France, there is organized colorectal cancer screening, which relies on general practitioners (GPs). Tests delivered by GPs are performed in 89% of cases. However, GPs do not systematically offer the test, for time management and communication reasons. Patients expect their GPs to offer the test and to focus on their expectations. A previous study conducted on GPs showed that training in communication and motivational interviewing increases the number of tests performed by 12.2%.

In order to facilitate the promotion of screening, the investigators would like to develop a training programme for GPs focusing on the application of Motivational Interviewing (MI) techniques to the promotion of colorectal cancer screening.

Motivational Interviewing is a directive, client-centered counseling style for eliciting behavior change by helping clients to explore and resolve ambivalence.

This study is a multicenter trial in general medicine. In this randomized trial the 902 subjects will be included prospectively by the general practitioners (GP) participating in the study.

As a first step, general practitioners who have never participated in Motivational Interviewing training will be recruited and split into 2 groups by randomization, an intervention group and a control group. The interventional group will then undergo a 3 times 2-day training in Motivational Interviewing.

In a second step, the patients will be included by those GP and a self-questionnaire will be send at the inclusion and after 6, 12 and 24 months. The evaluation of the number of tests performed and the analyse of the Health Belief Model (HBM) self-questionnaire will be carried out.

At 24 months, there will be an evaluation of the denial motivation questionnaire for patients who have not participated in organized colorectal cancer screening.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Interaction between patient and trained general practitioners in motivational interviewing

• Study Type: Interventional
• Enrollment (Anticipated): 902
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean Yves Le Reste, Pr; Phone Number: +33 02 98 01 65 52; Email: lereste@univ-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • Not yet recruiting
    • Dr ABALAIN
    • Contact: Aurélie ABALAIN, Dr
  • Brest, France, 29200
    • Recruiting
    • Dr HENRY
    • Contact: Pierre HENRY, Dr
  • Brest, France, 29200
    • Not yet recruiting
    • Dr PETTON-HILI
    • Contact: Anne-Laure PETTON-HILI, Dr
  • Châteauneuf-du-Faou, France, 29520
    • Not yet recruiting
    • Dr DENIEL
    • Contact: Magalie DENIEL, Dr
  • Châteauneuf-du-Faou, France, 29520
    • Not yet recruiting
    • Dr LE BOURHIS
    • Contact: Erwan LE BOURHIS, Dr
  • Clohars-Carnoët, France, 29360
    • Not yet recruiting
    • Dr PERRIER
    • Contact: Isabelle Clohars-Carnoët, Dr
  • Crozon, France, 29160
    • Not yet recruiting
    • Dr CHAPOIX
    • Contact: Nicolas CHAPOIX, Dr
  • Daoulas, France, 29460
    • Not yet recruiting
    • Dr OLIVIER
    • Contact: Eric OLIVIER, Dr
  • Douarnenez, France, 29100
    • Not yet recruiting
    • Dr ATTENCOURT
    • Contact: Christophe ATTENCOURT, Dr
  • Douarnenez, France, 29100
    • Not yet recruiting
    • Dr KERVELLA
    • Contact: Sylvie KERVELLA, Dr
  • Ergué-Gabéric, France, 29500
    • Not yet recruiting
    • Dr VELLY
    • Contact: Jean-François VELLY, Dr
  • Esquibien, France, 29770
    • Not yet recruiting
    • Dr BLANCHARD
    • Contact: Julie BLANCHARD, Dr
  • Esquibien, France, 29770
    • Not yet recruiting
    • Dr DESNOT
    • Contact: Richard DESNOT, Dr
  • Esquibien, France, 29770
    • Not yet recruiting
    • Dr VIALA
    • Contact: Jeanlin VIALA, Dr
  • Fouesnant, France, 29170
    • Not yet recruiting
    • Dr DAOUDAL
    • Contact: Aurore DAOUDAL, Dr
  • Fouesnant, France, 29170
    • Not yet recruiting
    • Dr LEFEVRE
    • Contact: Maxime LEFEVRE, Dr
  • Fouesnant, France, 29170
    • Not yet recruiting
    • Dr MAGADUR
    • Contact: Véronique MAGADUR, Dr
  • Guerlesquin, France, 29650
    • Not yet recruiting
    • Dr MUNCK
    • Contact: Pauline MUNCK, Dr
  • Guerlesquin, France, 29650
    • Not yet recruiting
    • Dr POINOT
    • Contact: Anne POINOT, Dr
  • Guilvinec, France, 29730
    • Not yet recruiting
    • Dr LE FLOCH
    • Contact: Bernard LE FLOCH, Dr
  • Guisseny, France, 29880
    • Not yet recruiting
    • Dr LE GRIGNOU
    • Contact: Caroline LE GRIGNOU, Dr
  • Landivisiau, France, 29400
    • Not yet recruiting
    • Dr PITMAN
    • Contact: Roberto PITMAN, Dr
  • Lanmeur, France, 29260
    • Not yet recruiting
    • Dr COLLETER
    • Contact: Manuel COLLETER, Dr
  • Lanmeur, France, 29260
    • Not yet recruiting
    • Dr CRENN-CORVEZ
    • Contact: Hélène CRENN-CORVEZ, Dr
  • Lanmeur, France, 29620
    • Not yet recruiting
    • Dr BECK-ROBERT
    • Contact: Emilie BECK-ROBERT, Dr
  • Lannilis, France, 29870
    • Not yet recruiting
    • Dr BARAIS
    • Contact: Marie BARAIS, Dr
  • Le Conquet, France, 29217
    • Not yet recruiting
    • Dr VERBEQUE MORVAN
    • Contact: Manon VERBEQUE MORVAN, Dr
  • Le Faou, France, 29590
    • Not yet recruiting
    • Dr TREBAOL
    • Contact: Emmanuelle TREBAOL, Dr
  • Le Relecq-Kerhuon, France, 29480
    • Not yet recruiting
    • Dr GRALL
    • Contact: Olivier GRALL, Dr
  • Loperhet, France, 29470
    • Not yet recruiting
    • Dr BOUTERAON
    • Contact: Sylvie BOUTERAON, Dr
  • Moelan Sur Mer, France, 29350
    • Not yet recruiting
    • Dr PIPET-PENIN
    • Contact: Gaëlle PIPET-PENIN, Dr
  • Pleyben, France, 29190
    • Not yet recruiting
    • Dr BEURTON-COURAUD
    • Contact: Lucas BEURTON-COURAUD, Dr
  • Pleyben, France, 29190
    • Not yet recruiting
    • Dr LUCAS
    • Contact: Aldric LUCAS, Dr
  • Pleyber-Christ, France, 29410
    • Not yet recruiting
    • Dr KERFRIDEN KERHOAS
    • Contact: Morgane KERFRIDEN KERHOAS, Dr
  • Plonévez-Porzay, France, 29550
    • Not yet recruiting
    • Dr BAUTA
    • Contact: Vincent BAUTA, Dr
  • Plonévez-Porzay, France, 29550
    • Not yet recruiting
    • Dr COGNEAU
    • Contact: Clément COGNEAU, Dr
  • Ploudalmezeau, France, 29830
    • Not yet recruiting
    • Dr GASNIER
    • Contact: Anne-Laure GASNIER, Dr
  • Plouezoc'h, France, 29252
    • Not yet recruiting
    • Dr AOUDIA
    • Contact: Seddik AOUDIA, Dr
  • Plougonven, France, 29640
    • Not yet recruiting
    • Dr LOPIN
    • Contact: Céline LOPIN, Dr
  • Plouhinec, France, 29780
    • Not yet recruiting
    • Dr DROGOU
    • Contact: Marine DROGOU, Dr
  • Plouneour Trez, France, 29890
    • Not yet recruiting
    • Dr BODIN
    • Contact: Bénédicte BODIN, Dr
  • Plouzané, France, 29280
    • Not yet recruiting
    • Dr DE LA SOUDIERE
    • Contact: Ségolène DE LA SOUDIERE, Dr
  • Pont l'Abbé, France, 29120
    • Not yet recruiting
    • Dr PETIT
    • Contact: Elisabeth PETIT, Dr
  • Pouldreuzic, France, 29710
    • Not yet recruiting
    • Dr PREVOT
    • Contact: Jeanne PREVOT, Dr
  • Quimper, France, 29000
    • Not yet recruiting
    • Dr AUTRET
    • Contact: Hervé AUTRET, Dr
  • Quimper, France, 29000
    • Not yet recruiting
    • Dr COROLLER
    • Contact: Philippe COROLLER, Dr
  • Quimper, France, 29000
    • Not yet recruiting
    • Dr COUTURIER
    • Contact: Thomas COUTURIER, Dr
  • Quimper, France, 29000
    • Not yet recruiting
    • Dr JOLIVET COUTURE
    • Contact: Anne JOLIVET COUTURE, Dr
  • Quimper, France, 29000
    • Not yet recruiting
    • Dr KERGASTEL
    • Contact: Hélène KERGASTEL, Dr
  • Saint-Martin-des-Champs, France, 29600
    • Not yet recruiting
    • Dr BARCELO
    • Contact: Luc BARCELO, Dr
  • Spezet, France, 29540
    • Not yet recruiting
    • Dr MAILLEUCHET
    • Contact: Jean-François MAILLEUCHET, Dr
  • St Yvi, France, 29140
    • Not yet recruiting
    • Dr MONFORT
    • Contact: Xavier MONFORT, Dr
  • Trégunc, France, 29910
    • Not yet recruiting
    • Dr NICOLAS
    • Contact: Anne-Catherine NICOLAS, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People with an average risk of colorectal cancer (presenting no symptoms or risk factors).
• People living in Finistère.
• People aged 50 to 74 who have never participated in organized screening for colorectal cancer.

Exclusion Criteria:

• Persons without address to receive the Health Belief Model (HBM)questionnaire
• People who do not fit the organized screening criteria
• Persons unable to give consent (patients under guardianship, curatorship, non-French speaking, illiterate)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physicians trained in motivational interviewing; Patients followed by general practitioners trained in motivational interviewing	Behavioral: Interaction between patient and trained general practitioners in motivational interviewing; Impact of the medical interview on the patient; Other Names: Experimental arm
No Intervention: Physicians did not trainned in motivational interviewing; Patients followed by general practitioners who did not receive motivational interviewing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of organised colorectal cancer screening at 24 months	The impact of training general practitioners in motivational interviewing on the rate of organised colorectal cancer screening will be assessed by determining whether or not the immunological test proposed as part of organised colorectal cancer screening at 24 months will be carried out.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of organised colorectal cancer screening at 12 months	Whether or not to perform the proposed immunological test as part of organized colorectal cancer screening at 12 months.	12 months
Changes in perceptions of colorectal cancer screening	Changes in perceptions of colorectal cancer screening will be assessed using a Health Belief Model (HBM). The Health Belief Model (HBM) is a social psychological health behavior change model developed to explain and predict health-related behaviors, particularly in regard to the uptake of health services. This Health Belief Model use for this study evaluate : individual perceptions (perceived susceptibility and severity), modifying factors (perceived threat and cues to action) and likelihood of action (perceived benefit and perception barriers and taking health action) at Day 0, Month 6, Month 12 and Month 24.	Day 0, 6 months, 12 months and 24 months
Evolution of the self-assessment of life expectancy	Patients will answer a question to find out their self-assessment of life expectancy.	Day 0, 6 months, 12 months and 24 months
Identification of denial of the colorectal cancer screening	Understand why patients refuse colorectal cancer screening of by identificating et quantificating reasons why the patient did not realised the colorectal cancer screening at 24 months of follow up.	24 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Publications and helpful links

General Publications

• Aujoulat P, Le Goff D, Dany A, Robaskiewick M, Nousbaum JB, Derrienic J, Cariou M, Guillou M, Le Reste JY. Improvement of participation rate in colorectal cancer (CRC) screening by training general practitioners in motivational interviewing (AmDepCCR). Trials. 2022 Feb 14;23(1):144. doi: 10.1186/s13063-022-06056-8.

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2021
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Motivational interviewing; Colorectal cancer; General practitioners
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 29BRC19.0115 (AMDepCCR); 2019-A01776-51 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning 42 months ending fifteen years following the final study report completion.
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No