Colorectal CancerAMDepCCRNCT04492215
General Practitioners and Participation Rate in ColoRectal Cancer Screening
A study testing Interaction between patient and trained general practitioners in motivational interviewing in people with Colorectal Cancer, run by University Hospital, Brest at 53 sites in France.
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). Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Interaction between patient and trained general practitioners in motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 902 participants
- Where
- 53 sitesFrance
- Study dates
- 31 May 2021to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
France53 sites, 53 recruiting
- Not yet recruiting
Dr ABALAIN
Brest, 29200
Aurélie ABALAIN, Dr
- Recruiting
Dr HENRY
Brest, 29200
Pierre HENRY, Dr
- Not yet recruiting
Dr PETTON-HILI
Brest, 29200
Anne-Laure PETTON-HILI, Dr
- Not yet recruiting
Dr DENIEL
Châteauneuf-du-Faou, 29520
Magalie DENIEL, Dr
- Not yet recruiting
Dr LE BOURHIS
Châteauneuf-du-Faou, 29520
Erwan LE BOURHIS, Dr
- Not yet recruiting
Dr PERRIER
Clohars-Carnoët, 29360
Isabelle Clohars-Carnoët, Dr
- Not yet recruiting
Dr CHAPOIX
Crozon, 29160
Nicolas CHAPOIX, Dr
- Not yet recruiting
Dr OLIVIER
Daoulas, 29460
Eric OLIVIER, Dr
- Not yet recruiting
Dr ATTENCOURT
Douarnenez, 29100
Christophe ATTENCOURT, Dr
- Not yet recruiting
Dr KERVELLA
Douarnenez, 29100
Sylvie KERVELLA, Dr
- Not yet recruiting
Dr VELLY
Ergué-Gabéric, 29500
Jean-François VELLY, Dr
- Not yet recruiting
Dr BLANCHARD
Esquibien, 29770
Julie BLANCHARD, Dr
- Not yet recruiting
Dr DESNOT
Esquibien, 29770
Richard DESNOT, Dr
- Not yet recruiting
Dr VIALA
Esquibien, 29770
Jeanlin VIALA, Dr
- Not yet recruiting
Dr DAOUDAL
Fouesnant, 29170
Aurore DAOUDAL, Dr
- Not yet recruiting
Dr LEFEVRE
Fouesnant, 29170
Maxime LEFEVRE, Dr
- Not yet recruiting
Dr MAGADUR
Fouesnant, 29170
Véronique MAGADUR, Dr
- Not yet recruiting
Dr MUNCK
Guerlesquin, 29650
Pauline MUNCK, Dr
- Not yet recruiting
Dr POINOT
Guerlesquin, 29650
Anne POINOT, Dr
- Not yet recruiting
Dr LE FLOCH
Guilvinec, 29730
Bernard LE FLOCH, Dr
- Not yet recruiting
Dr LE GRIGNOU
Guissény, 29880
Caroline LE GRIGNOU, Dr
- Not yet recruiting
Dr PITMAN
Landivisiau, 29400
Roberto PITMAN, Dr
- Not yet recruiting
Dr COLLETER
Lanmeur, 29260
Manuel COLLETER, Dr
- Not yet recruiting
Dr CRENN-CORVEZ
Lanmeur, 29260
Hélène CRENN-CORVEZ, Dr
- Not yet recruiting
Dr BECK-ROBERT
Lanmeur, 29620
Emilie BECK-ROBERT, Dr
- Not yet recruiting
Dr BARAIS
Lannilis, 29870
Marie BARAIS, Dr
- Not yet recruiting
Dr VERBEQUE MORVAN
Le Conquet, 29217
Manon VERBEQUE MORVAN, Dr
- Not yet recruiting
Dr TREBAOL
Le Faou, 29590
Emmanuelle TREBAOL, Dr
- Not yet recruiting
Dr GRALL
Le Relecq-Kerhuon, 29480
Olivier GRALL, Dr
- Not yet recruiting
Dr BOUTERAON
Loperhet, 29470
Sylvie BOUTERAON, Dr
- Not yet recruiting
Dr PIPET-PENIN
Moëlan-sur-Mer, 29350
Gaëlle PIPET-PENIN, Dr
- Not yet recruiting
Dr BEURTON-COURAUD
Pleyben, 29190
Lucas BEURTON-COURAUD, Dr
- Not yet recruiting
Dr LUCAS
Pleyben, 29190
Aldric LUCAS, Dr
- Not yet recruiting
Dr KERFRIDEN KERHOAS
Pleyber-Christ, 29410
Morgane KERFRIDEN KERHOAS, Dr
- Not yet recruiting
Dr BAUTA
Plonévez-Porzay, 29550
Vincent BAUTA, Dr
- Not yet recruiting
Dr COGNEAU
Plonévez-Porzay, 29550
Clément COGNEAU, Dr
- Not yet recruiting
Dr GASNIER
Ploudalmézeau, 29830
Anne-Laure GASNIER, Dr
- Not yet recruiting
Dr AOUDIA
Plouezoc'h, 29252
Seddik AOUDIA, Dr
- Not yet recruiting
Dr LOPIN
Plougonven, 29640
Céline LOPIN, Dr
- Not yet recruiting
Dr DROGOU
Plouhinec, 29780
Marine DROGOU, Dr
- Not yet recruiting
Dr BODIN
Plounéour-Trez, 29890
Bénédicte BODIN, Dr
- Not yet recruiting
Dr DE LA SOUDIERE
Plouzané, 29280
Ségolène DE LA SOUDIERE, Dr
- Not yet recruiting
Dr PETIT
Pont-l'Abbé, 29120
Elisabeth PETIT, Dr
- Not yet recruiting
Dr PREVOT
Pouldreuzic, 29710
Jeanne PREVOT, Dr
- Not yet recruiting
Dr AUTRET
Quimper, 29000
Hervé AUTRET, Dr
- Not yet recruiting
Dr COROLLER
Quimper, 29000
Philippe COROLLER, Dr
- Not yet recruiting
Dr COUTURIER
Quimper, 29000
Thomas COUTURIER, Dr
- Not yet recruiting
Dr JOLIVET COUTURE
Quimper, 29000
Anne JOLIVET COUTURE, Dr
- Not yet recruiting
Dr KERGASTEL
Quimper, 29000
Hélène KERGASTEL, Dr
- Not yet recruiting
Dr BARCELO
Saint-Martin-des-Champs, 29600
Luc BARCELO, Dr
- Not yet recruiting
Dr MONFORT
Saint-Yvi, 29140
Xavier MONFORT, Dr
- Not yet recruiting
Dr MAILLEUCHET
Spézet, 29540
Jean-François MAILLEUCHET, Dr
- Not yet recruiting
Dr NICOLAS
Trégunc, 29910
Anne-Catherine NICOLAS, Dr
About this study
Official title: 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%.
Read more
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.
- Conditions
- Colorectal Cancer
- Being tested
- Interaction between patient and trained general practitioners in motivational interviewing
- Keywords
- Colorectal cancer, General practitioners, Motivational interviewing
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interaction between patient and trained general practitioners in motivational interviewingBehavioural
Also called Experimental arm
Impact of the medical interview on the patient
| Study group | Role | What they receive |
|---|---|---|
| Physicians trained in motivational interviewing | Experimental | Patients followed by general practitioners trained in motivational interviewing Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start31 May 2021
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 902 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492215
- Sponsor's protocol ID
- 29BRC19.0115 (AMDepCCR)
- Other IDs
- 2019-A01776-51
- Acronym
- AMDepCCR
- Status last verified
- Apr 2023
- First submitted
- 27 Jul 2020
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Participation Rate in ColoRectal Cancer Screening by Training General Practitioners in Motivational Interviewing
- ClinicalTrials.gov ID
- NCT04492215
- Acronym / sponsor ID
- AMDepCCR / 29BRC19.0115 (AMDepCCR)
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, General practitioners, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 902 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Physicians trained in motivational interviewing | Experimental | Behavioral: Interaction between patient and trained general practitioners in motivational interviewingPatients followed by general practitioners trained in motivational interviewing |
| Physicians did not trainned in motivational interviewing | No intervention | –Patients followed by general practitioners who did not receive motivational interviewing. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interaction between patient and trained general practitioners in motivational interviewingAlso: Experimental armImpact of the medical interview on the patient | Behavioural | Physicians trained in motivational interviewing |
Primary outcome
Rate of organised colorectal cancer screening at 24 months
Time frame: 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.
4 secondary outcomes
Rate of organised colorectal cancer screening at 12 months
Time frame: 12 months
Changes in perceptions of colorectal cancer screening
Time frame: Day 0, 6 months, 12 months and 24 months
Evolution of the self-assessment of life expectancy
Time frame: Day 0, 6 months, 12 months and 24 months
Identification of denial of the colorectal cancer screening
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Derived from this study: PubMed 35164836Aujoulat 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction between patient and trained general practitioners in motivational interviewing in people with Colorectal Cancer, run by University Hospital, Brest at 53 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Yves Le Reste, Pr (02 98 01 65 52 ext. +33, lereste@univ-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of organised colorectal cancer screening at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492215, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.