NCT04492215

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
902

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started May 2021

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

53 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

May 31, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

April 7, 2023

Status Verified

April 1, 2023

Enrollment Period

2 years

First QC Date

July 27, 2020

Last Update Submit

April 6, 2023

Conditions

Keywords

Colorectal cancerGeneral practitionersMotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Rate of organised colorectal cancer screening at 12 months

    12 months

  • Changes in perceptions of colorectal cancer screening

    Day 0, 6 months, 12 months and 24 months

  • Evolution of the self-assessment of life expectancy

    Day 0, 6 months, 12 months and 24 months

  • Identification of denial of the colorectal cancer screening

    24 months

Study Arms (2)

Physicians trained in motivational interviewing

EXPERIMENTAL

Patients followed by general practitioners trained in motivational interviewing

Behavioral: Interaction between patient and trained general practitioners in motivational interviewing

Physicians did not trainned in motivational interviewing

NO INTERVENTION

Patients followed by general practitioners who did not receive motivational interviewing.

Interventions

Impact of the medical interview on the patient

Also known as: Experimental arm
Physicians trained in motivational interviewing

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (53)

Dr ABALAIN

Brest, 29200, France

NOT YET RECRUITING

Dr HENRY

Brest, 29200, France

RECRUITING

Dr PETTON-HILI

Brest, 29200, France

NOT YET RECRUITING

Dr DENIEL

Châteauneuf-du-Faou, 29520, France

NOT YET RECRUITING

Dr LE BOURHIS

Châteauneuf-du-Faou, 29520, France

NOT YET RECRUITING

Dr PERRIER

Clohars-Carnoët, 29360, France

NOT YET RECRUITING

Dr CHAPOIX

Crozon, 29160, France

NOT YET RECRUITING

Dr OLIVIER

Daoulas, 29460, France

NOT YET RECRUITING

Dr ATTENCOURT

Douarnenez, 29100, France

NOT YET RECRUITING

Dr KERVELLA

Douarnenez, 29100, France

NOT YET RECRUITING

Dr VELLY

Ergué-Gabéric, 29500, France

NOT YET RECRUITING

Dr BLANCHARD

Esquibien, 29770, France

NOT YET RECRUITING

Dr DESNOT

Esquibien, 29770, France

NOT YET RECRUITING

Dr VIALA

Esquibien, 29770, France

NOT YET RECRUITING

Dr DAOUDAL

Fouesnant, 29170, France

NOT YET RECRUITING

Dr LEFEVRE

Fouesnant, 29170, France

NOT YET RECRUITING

Dr MAGADUR

Fouesnant, 29170, France

NOT YET RECRUITING

Dr MUNCK

Guerlesquin, 29650, France

NOT YET RECRUITING

Dr POINOT

Guerlesquin, 29650, France

NOT YET RECRUITING

Dr LE FLOCH

Guilvinec, 29730, France

NOT YET RECRUITING

Dr LE GRIGNOU

Guissény, 29880, France

NOT YET RECRUITING

Dr PITMAN

Landivisiau, 29400, France

NOT YET RECRUITING

Dr COLLETER

Lanmeur, 29260, France

NOT YET RECRUITING

Dr CRENN-CORVEZ

Lanmeur, 29260, France

NOT YET RECRUITING

Dr BECK-ROBERT

Lanmeur, 29620, France

NOT YET RECRUITING

Dr BARAIS

Lannilis, 29870, France

NOT YET RECRUITING

Dr VERBEQUE MORVAN

Le Conquet, 29217, France

NOT YET RECRUITING

Dr TREBAOL

Le Faou, 29590, France

NOT YET RECRUITING

Dr GRALL

Le Relecq-Kerhuon, 29480, France

NOT YET RECRUITING

Dr BOUTERAON

Loperhet, 29470, France

NOT YET RECRUITING

Dr PIPET-PENIN

Moëlan-sur-Mer, 29350, France

NOT YET RECRUITING

Dr BEURTON-COURAUD

Pleyben, 29190, France

NOT YET RECRUITING

Dr LUCAS

Pleyben, 29190, France

NOT YET RECRUITING

Dr KERFRIDEN KERHOAS

Pleyber-Christ, 29410, France

NOT YET RECRUITING

Dr BAUTA

Plonévez-Porzay, 29550, France

NOT YET RECRUITING

Dr COGNEAU

Plonévez-Porzay, 29550, France

NOT YET RECRUITING

Dr GASNIER

Ploudalmézeau, 29830, France

NOT YET RECRUITING

Dr AOUDIA

Plouezoc'h, 29252, France

NOT YET RECRUITING

Dr LOPIN

Plougonven, 29640, France

NOT YET RECRUITING

Dr DROGOU

Plouhinec, 29780, France

NOT YET RECRUITING

Dr BODIN

Plounéour-Trez, 29890, France

NOT YET RECRUITING

Dr DE LA SOUDIERE

Plouzané, 29280, France

NOT YET RECRUITING

Dr PETIT

Pont-l'Abbé, 29120, France

NOT YET RECRUITING

Dr PREVOT

Pouldreuzic, 29710, France

NOT YET RECRUITING

Dr AUTRET

Quimper, 29000, France

NOT YET RECRUITING

Dr COROLLER

Quimper, 29000, France

NOT YET RECRUITING

Dr COUTURIER

Quimper, 29000, France

NOT YET RECRUITING

Dr JOLIVET COUTURE

Quimper, 29000, France

NOT YET RECRUITING

Dr KERGASTEL

Quimper, 29000, France

NOT YET RECRUITING

Dr BARCELO

Saint-Martin-des-Champs, 29600, France

NOT YET RECRUITING

Dr MONFORT

Saint-Yvi, 29140, France

NOT YET RECRUITING

Dr MAILLEUCHET

Spézet, 29540, France

NOT YET RECRUITING

Dr NICOLAS

Trégunc, 29910, France

NOT YET RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Jean Yves Le Reste, Pr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The study is based on the participation of general practitioners in a training, the test is necessarily open for doctors. However patients will not know if their doctor has received training and will be blinded..
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This study is a multicenter trial. Patients will be followed either by GPs from the interventional group who participated in motivational interviewing or by the control group who never participated. The distribution of general practitioners in the groups is done thanks random draw.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2020

First Posted

July 30, 2020

Study Start

May 31, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2025

Last Updated

April 7, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 42 months ending fifteen years following the final study report completion.
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.

Locations