General Practitioners and Participation Rate in ColoRectal Cancer Screening

Colorectal Cancer Clinical Trial

— AMDepCCR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04492215
• Other study ID #: 29BRC19.0115 (AMDepCCR)
• Secondary ID: 2019-A01776-51
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2021
• Est. completion date: May 31, 2025

Study information

• Verified date: April 2023
• Source: University Hospital, Brest
• Contact: Jean Yves Le Reste, Pr
• Phone: 02 98 01 65 52
• Email: lereste[@]univ-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 902
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Interaction between patient and trained general practitioners in motivational interviewing
Impact of the medical interview on the patient

Locations

Country	Name	City	State
France	Dr ABALAIN	Brest
France	Dr HENRY	Brest
France	Dr PETTON-HILI	Brest
France	Dr DENIEL	Châteauneuf-du-Faou
France	Dr LE BOURHIS	Châteauneuf-du-Faou
France	Dr PERRIER	Clohars-Carnoët
France	Dr CHAPOIX	Crozon
France	Dr OLIVIER	Daoulas
France	Dr ATTENCOURT	Douarnenez
France	Dr KERVELLA	Douarnenez
France	Dr VELLY	Ergué-Gabéric
France	Dr BLANCHARD	Esquibien
France	Dr DESNOT	Esquibien
France	Dr VIALA	Esquibien
France	Dr DAOUDAL	Fouesnant
France	Dr LEFEVRE	Fouesnant
France	Dr MAGADUR	Fouesnant
France	Dr MUNCK	Guerlesquin
France	Dr POINOT	Guerlesquin
France	Dr LE FLOCH	Guilvinec
France	Dr LE GRIGNOU	Guisseny
France	Dr PITMAN	Landivisiau
France	Dr BECK-ROBERT	Lanmeur
France	Dr COLLETER	Lanmeur
France	Dr CRENN-CORVEZ	Lanmeur
France	Dr BARAIS	Lannilis
France	Dr VERBEQUE MORVAN	Le Conquet
France	Dr TREBAOL	Le Faou
France	Dr GRALL	Le Relecq-Kerhuon
France	Dr BOUTERAON	Loperhet
France	Dr PIPET-PENIN	Moelan Sur Mer
France	Dr BEURTON-COURAUD	Pleyben
France	Dr LUCAS	Pleyben
France	Dr KERFRIDEN KERHOAS	Pleyber-Christ
France	Dr BAUTA	Plonévez-Porzay
France	Dr COGNEAU	Plonévez-Porzay
France	Dr GASNIER	Ploudalmezeau
France	Dr AOUDIA	Plouezoc'h
France	Dr LOPIN	Plougonven
France	Dr DROGOU	Plouhinec
France	Dr BODIN	Plouneour Trez
France	Dr DE LA SOUDIERE	Plouzané
France	Dr PETIT	Pont l'Abbé
France	Dr PREVOT	Pouldreuzic
France	Dr AUTRET	Quimper
France	Dr COROLLER	Quimper
France	Dr COUTURIER	Quimper
France	Dr JOLIVET COUTURE	Quimper
France	Dr KERGASTEL	Quimper
France	Dr BARCELO	Saint-Martin-des-Champs
France	Dr MAILLEUCHET	Spezet
France	Dr MONFORT	St Yvi
France	Dr NICOLAS	Trégunc

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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