CClinicalTrials.gg
RecruitingNCT04492215AMDepCCRUpdated Apr 7, 2023

General Practitioners and Participation Rate in ColoRectal Cancer Screening

An interventional study of Interaction between patient and trained general practitioners in motivational interviewing in Colorectal Cancer, sponsored by University Hospital, Brest. Recruiting at 53 sites in France. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2023-04-07.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by May 2023, 3 years 4 months ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
902
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer

Keywords

  • Colorectal cancer
  • General practitioners
  • Motivational interviewing
03

In context

Colorectal Neoplasms

5,600 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 902 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
902 participants (estimated)

Study arms

  • 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

  • No intervention
    Physicians did not trainned in motivational interviewing

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

Interventions

  • BehavioralInteraction between patient and trained general practitioners in motivational interviewing

    Impact of the medical interview on the patient

    Also known as: Experimental arm

06

What researchers measure

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.

    Time frame: 24 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. 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.

    Time frame: Day 0, 6 months, 12 months and 24 months

  3. Evolution of the self-assessment of life expectancy

    Patients will answer a question to find out their self-assessment of life expectancy.

    Time frame: Day 0, 6 months, 12 months and 24 months

  4. 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.

    Time frame: 24 months

07

Study locations

1 of 53 sites recruiting
  • Dr ABALAIN
    Brest, 29200, France
    • Aurélie ABALAIN, Dr · Contact
    Not yet recruiting
  • Dr HENRY
    Brest, 29200, France
    • Pierre HENRY, Dr · Contact
    Recruiting
  • Dr PETTON-HILI
    Brest, 29200, France
    • Anne-Laure PETTON-HILI, Dr · Contact
    Not yet recruiting
  • Dr DENIEL
    Châteauneuf-du-Faou, 29520, France
    • Magalie DENIEL, Dr · Contact
    Not yet recruiting
  • Dr LE BOURHIS
    Châteauneuf-du-Faou, 29520, France
    • Erwan LE BOURHIS, Dr · Contact
    Not yet recruiting
  • Dr PERRIER
    Clohars-Carnoët, 29360, France
    • Isabelle Clohars-Carnoët, Dr · Contact
    Not yet recruiting
  • Dr CHAPOIX
    Crozon, 29160, France
    • Nicolas CHAPOIX, Dr · Contact
    Not yet recruiting
  • Dr OLIVIER
    Daoulas, 29460, France
    • Eric OLIVIER, Dr · Contact
    Not yet recruiting
  • Dr ATTENCOURT
    Douarnenez, 29100, France
    • Christophe ATTENCOURT, Dr · Contact
    Not yet recruiting
  • Dr KERVELLA
    Douarnenez, 29100, France
    • Sylvie KERVELLA, Dr · Contact
    Not yet recruiting
  • Dr VELLY
    Ergué-Gabéric, 29500, France
    • Jean-François VELLY, Dr · Contact
    Not yet recruiting
  • Dr BLANCHARD
    Esquibien, 29770, France
    • Julie BLANCHARD, Dr · Contact
    Not yet recruiting
  • Dr DESNOT
    Esquibien, 29770, France
    • Richard DESNOT, Dr · Contact
    Not yet recruiting
  • Dr VIALA
    Esquibien, 29770, France
    • Jeanlin VIALA, Dr · Contact
    Not yet recruiting
  • Dr DAOUDAL
    Fouesnant, 29170, France
    • Aurore DAOUDAL, Dr · Contact
    Not yet recruiting
  • Dr LEFEVRE
    Fouesnant, 29170, France
    • Maxime LEFEVRE, Dr · Contact
    Not yet recruiting
  • Dr MAGADUR
    Fouesnant, 29170, France
    • Véronique MAGADUR, Dr · Contact
    Not yet recruiting
  • Dr MUNCK
    Guerlesquin, 29650, France
    • Pauline MUNCK, Dr · Contact
    Not yet recruiting
  • Dr POINOT
    Guerlesquin, 29650, France
    • Anne POINOT, Dr · Contact
    Not yet recruiting
  • Dr LE FLOCH
    Guilvinec, 29730, France
    • Bernard LE FLOCH, Dr · Contact
    Not yet recruiting
  • Dr LE GRIGNOU
    Guisseny, 29880, France
    • Caroline LE GRIGNOU, Dr · Contact
    Not yet recruiting
  • Dr PITMAN
    Landivisiau, 29400, France
    • Roberto PITMAN, Dr · Contact
    Not yet recruiting
  • Dr COLLETER
    Lanmeur, 29260, France
    • Manuel COLLETER, Dr · Contact
    Not yet recruiting
  • Dr CRENN-CORVEZ
    Lanmeur, 29260, France
    • Hélène CRENN-CORVEZ, Dr · Contact
    Not yet recruiting
  • Dr BECK-ROBERT
    Lanmeur, 29620, France
    • Emilie BECK-ROBERT, Dr · Contact
    Not yet recruiting
  • Dr BARAIS
    Lannilis, 29870, France
    • Marie BARAIS, Dr · Contact
    Not yet recruiting
  • Dr VERBEQUE MORVAN
    Le Conquet, 29217, France
    • Manon VERBEQUE MORVAN, Dr · Contact
    Not yet recruiting
  • Dr TREBAOL
    Le Faou, 29590, France
    • Emmanuelle TREBAOL, Dr · Contact
    Not yet recruiting
  • Dr GRALL
    Le Relecq-Kerhuon, 29480, France
    • Olivier GRALL, Dr · Contact
    Not yet recruiting
  • Dr BOUTERAON
    Loperhet, 29470, France
    • Sylvie BOUTERAON, Dr · Contact
    Not yet recruiting
  • Dr PIPET-PENIN
    Moelan Sur Mer, 29350, France
    • Gaëlle PIPET-PENIN, Dr · Contact
    Not yet recruiting
  • Dr BEURTON-COURAUD
    Pleyben, 29190, France
    • Lucas BEURTON-COURAUD, Dr · Contact
    Not yet recruiting
  • Dr LUCAS
    Pleyben, 29190, France
    • Aldric LUCAS, Dr · Contact
    Not yet recruiting
  • Dr KERFRIDEN KERHOAS
    Pleyber-Christ, 29410, France
    • Morgane KERFRIDEN KERHOAS, Dr · Contact
    Not yet recruiting
  • Dr BAUTA
    Plonévez-Porzay, 29550, France
    • Vincent BAUTA, Dr · Contact
    Not yet recruiting
  • Dr COGNEAU
    Plonévez-Porzay, 29550, France
    • Clément COGNEAU, Dr · Contact
    Not yet recruiting
  • Dr GASNIER
    Ploudalmezeau, 29830, France
    • Anne-Laure GASNIER, Dr · Contact
    Not yet recruiting
  • Dr AOUDIA
    Plouezoc'h, 29252, France
    • Seddik AOUDIA, Dr · Contact
    Not yet recruiting
  • Dr LOPIN
    Plougonven, 29640, France
    • Céline LOPIN, Dr · Contact
    Not yet recruiting
  • Dr DROGOU
    Plouhinec, 29780, France
    • Marine DROGOU, Dr · Contact
    Not yet recruiting
  • Dr BODIN
    Plouneour Trez, 29890, France
    • Bénédicte BODIN, Dr · Contact
    Not yet recruiting
  • Dr DE LA SOUDIERE
    Plouzané, 29280, France
    • Ségolène DE LA SOUDIERE, Dr · Contact
    Not yet recruiting
  • Dr PETIT
    Pont l'Abbé, 29120, France
    • Elisabeth PETIT, Dr · Contact
    Not yet recruiting
  • Dr PREVOT
    Pouldreuzic, 29710, France
    • Jeanne PREVOT, Dr · Contact
    Not yet recruiting
  • Dr AUTRET
    Quimper, 29000, France
    • Hervé AUTRET, Dr · Contact
    Not yet recruiting
  • Dr COROLLER
    Quimper, 29000, France
    • Philippe COROLLER, Dr · Contact
    Not yet recruiting
  • Dr COUTURIER
    Quimper, 29000, France
    • Thomas COUTURIER, Dr · Contact
    Not yet recruiting
  • Dr JOLIVET COUTURE
    Quimper, 29000, France
    • Anne JOLIVET COUTURE, Dr · Contact
    Not yet recruiting
  • Dr KERGASTEL
    Quimper, 29000, France
    • Hélène KERGASTEL, Dr · Contact
    Not yet recruiting
  • Dr BARCELO
    Saint-Martin-des-Champs, 29600, France
    • Luc BARCELO, Dr · Contact
    Not yet recruiting
  • Dr MAILLEUCHET
    Spezet, 29540, France
    • Jean-François MAILLEUCHET, Dr · Contact
    Not yet recruiting
  • Dr MONFORT
    St Yvi, 29140, France
    • Xavier MONFORT, Dr · Contact
    Not yet recruiting
  • Dr NICOLAS
    Trégunc, 29910, France
    • Anne-Catherine NICOLAS, Dr · Contact
    Not yet recruiting
08

References and documents

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. PubMed 35164836 ↗

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04492215
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Jul 30, 2020
Start date
May 31, 2021
Primary completion
May 31, 2023 (estimated)
Completion
May 31, 2025 (estimated)
Last update
Apr 7, 2023

Study contacts

Jean Yves Le Reste, Pr
Contact
lereste@univ-brest.fr
02 98 01 65 52 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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