Colorectal CancerFORCEPSNCT03938623
Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening
An observational study of Colorectal Cancer, run by Collège de la Médecine Générale, France at 1 site in France.
Trial summary
Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would… 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?
- Training
- How many people
- 274 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2018to 31 Dec 2020
- Phase
- Observational
- 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
Study population: All general practitioners practicing in the Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrénées, Poitou-Charentes, or Provence-Alpes-Cote-d'Azur regions will be requested Their patients are eligible if they are 50-74 years old and reside in one of the above regions.
Who may be able to join
- Patients aged 50 to 74,
- Residing in the regions of Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrenees, Poitou-Charentes, and Provence-Alpes-Côte-D'azur,
- Registered on the AMELI file of general practitioners participating in beginning of the study, before the training (ie the patients who have declared as a doctor one of the participating general practitioners).
- Affiliation to the general social security scheme
Who cannot join
- Patients excluded from screening for medical reasons (colorectal cancer or symptoms such as presence of red or black blood in the stool, other pathologies in non-priority treatment and screening)
- Patient having performed a Hemoccult® test / test immunological test for less than 2 years or had colonoscopy for less than 5 years.
- Patient who has declared as a treating physician one of the participating physicians for the duration of the study.
- Patient who did not consult for the duration of the study
Trial locations and contacts
1 site in 1 country.
About this study
Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.
Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention Intervention ; six hour educational training either in person or through e-learning The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories.
Read the detailed description
Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.
Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention .Given that the type of educational intervention modifies the global organization and medical practices of the participating centers, the randomization will be done at the level of GP's practice as a cluster unit in order to avoid contamination bias.
Population : All general practitioners practicing in the Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrénées, Poitou-Charentes, or Provence-Alpes-Cote-d'Azur regions will be requested Their patients are eligible if they are 50-74 years old and reside in one of the above regions.
212 centers are expected with 318 investigating doctors (an average of 1,5 doctors per center) and 42 358 total patients (21 179 patients in each arm) Intervention ; will be an educational training either in person or through e-learning GPs from practices in the control group were asked to continue their usual care, as if they were not participating in this trial. The whole procedure is the same all over the country i.e. all adults aged 50 to 74 of each GP's target population receive a letter every two years from the local cancer prevention association encouraging them to visit their GP and ask for the test. Patients must then send the test and a completed identity form, contained in an envelope to a central laboratory.
In the intervention group, participating GPs will receive a six-hour training course focusing on patient-centered care either in person or through e-learning . Two different scenarios for a video aiming to improve communication with patients were developed: one for a compliant patient, another for a non-compliant patient based on the four components of the patient centered clinical method
Objectives :
The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories The Secondary objectives are ;
- Assess the effectiveness of this training on moderate-risk patient participation in organized CRC screening
- Assess the effectiveness of this training on high-risk patient participation in targeted CRC screening
- Compare the effectiveness of in-person training versus e-learning
- Assess the effect of the training on whether the sequence of tests completed by patients is appropriate for their risk category (carrying out a test that was given to them, immediate refusal of the test, carrying out a colonoscopy if the test is positive) Assess the effectiveness of this training on reducing social inequalities in CRC screening participation Evaluation criteria : the primary endpoint is patient participation in the appropriate CRC screening for their level of risk (i.e. completing the Fecal Occult Blood Test [FOBT] if at moderate risk or a colonoscopy if at high risk) within 12 months of randomization. The secondary endpoints are: completing the FOBT for moderate risk patients, completing a colonoscopy for higher risk patients, proportion of dispensed tests that were completed , proportion of tests refused among those proposed, proportion of colonoscopies performed among those whose FOBT is positive, patient screening participation rate according to socio-economic level, proportion of tests that could not be interpreted
- Conditions
- Colorectal Cancer
- Being tested
- Training
- Keywords
- colorectal cancer, general practitioners, the patient-centered approach
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Also called The patient-centered approach
Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Training | Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening Receives: Other: Training | |
| Control | General Practitioners not using the patient-centered approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients screened positive using the patient-centered approach after training of face to face training or e-learning
Evaluate the effectiveness of face to face training or e-learning training to use the patient-centered approach
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start24 Jan 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- Collège de la Médecine Générale, France
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France
- Responsible party
- Sponsor
- Investigators
- AUBIN-AUGER M ISABELLE, MD, Pr, Principal investigator, COLLEGE DE LA MEDECINE GENERALE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938623
- Sponsor's protocol ID
- 2016IAN913
- Acronym
- FORCEPS
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2019
- Last updated
- 6 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT03938623
- Acronym / sponsor ID
- FORCEPS / 2016IAN913
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, general practitioners, the patient-centered approach
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (actual)
- Lead sponsor
- Collège de la Médecine Générale, FranceUniversity, hospital or other
- Collaborators
- National Cancer Institute, France
- Study start
- 24 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 May 2019 (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.
Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.
Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention Intervention ; six hour educational training either in person or through e-learning The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories.
Detailed description
Context : Colorectal cancer (CRC) mass screening has been implemented in France since 2008. Participation rates remain too low. The objective of this study is to test if the implementation of a training course focused on communication skills (whether in-person or e-learning) among general practitioners (GP) would increase the delivery of gFOBT and CRC screening participation among the target population of each participating GP.
Method : Pragmatic controlled cluster randomized trial with 2 parallel groups: Control versus Educational Intervention .Given that the type of educational intervention modifies the global organization and medical practices of the participating centers, the randomization will be done at the level of GP's practice as a cluster unit in order to avoid contamination bias.
Population : All general practitioners practicing in the Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrénées, Poitou-Charentes, or Provence-Alpes-Cote-d'Azur regions will be requested Their patients are eligible if they are 50-74 years old and reside in one of the above regions.
212 centers are expected with 318 investigating doctors (an average of 1,5 doctors per center) and 42 358 total patients (21 179 patients in each arm) Intervention ; will be an educational training either in person or through e-learning GPs from practices in the control group were asked to continue their usual care, as if they were not participating in this trial. The whole procedure is the same all over the country i.e. all adults aged 50 to 74 of each GP's target population receive a letter every two years from the local cancer prevention association encouraging them to visit their GP and ask for the test. Patients must then send the test and a completed identity form, contained in an envelope to a central laboratory.
In the intervention group, participating GPs will receive a six-hour training course focusing on patient-centered care either in person or through e-learning . Two different scenarios for a video aiming to improve communication with patients were developed: one for a compliant patient, another for a non-compliant patient based on the four components of the patient centered clinical method
Objectives :
The Main objective: is to evaluate the effectiveness of an educational intervention teaching physicians the patient-centered approach, either in-person or through e-learning, by evaluating their patients' participation in colorectal cancer (CRC) screening for all risk categories The Secondary objectives are ;
- Assess the effectiveness of this training on moderate-risk patient participation in organized CRC screening
- Assess the effectiveness of this training on high-risk patient participation in targeted CRC screening
- Compare the effectiveness of in-person training versus e-learning
- Assess the effect of the training on whether the sequence of tests completed by patients is appropriate for their risk category (carrying out a test that was given to them, immediate refusal of the test, carrying out a colonoscopy if the test is positive) Assess the effectiveness of this training on reducing social inequalities in CRC screening participation Evaluation criteria : the primary endpoint is patient participation in the appropriate CRC screening for their level of risk (i.e. completing the Fecal Occult Blood Test [FOBT] if at moderate risk or a colonoscopy if at high risk) within 12 months of randomization. The secondary endpoints are: completing the FOBT for moderate risk patients, completing a colonoscopy for higher risk patients, proportion of dispensed tests that were completed , proportion of tests refused among those proposed, proportion of colonoscopies performed among those whose FOBT is positive, patient screening participation rate according to socio-economic level, proportion of tests that could not be interpreted
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | – | Other: TrainingTeaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening |
| Control | – | –General Practitioners not using the patient-centered approach |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All general practitioners practicing in the Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrénées, Poitou-Charentes, or Provence-Alpes-Cote-d'Azur regions will be requested Their patients are eligible if they are 50-74 years old and reside in one of the above regions.
Key inclusion criteria (4 listed)
- Patients aged 50 to 74,
- Residing in the regions of Île-de-France, Languedoc-Roussillon, Loire-Atlantique, Midi-Pyrenees, Poitou-Charentes, and Provence-Alpes-Côte-D'azur,
- Registered on the AMELI file of general practitioners participating in beginning of the study, before the training (ie the patients who have declared as a doctor one of the participating general practitioners).
- Affiliation to the general social security scheme
Key exclusion criteria (4 listed)
- Patients excluded from screening for medical reasons (colorectal cancer or symptoms such as presence of red or black blood in the stool, other pathologies in non-priority treatment and screening)
- Patient having performed a Hemoccult® test / test immunological test for less than 2 years or had colonoscopy for less than 5 years.
- Patient who has declared as a treating physician one of the participating physicians for the duration of the study.
- Patient who did not consult for the duration of the study
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 |
|---|---|---|
| TrainingAlso: The patient-centered approachTeaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening | Other | Training |
Primary outcome
number of patients screened positive using the patient-centered approach after training of face to face training or e-learning
Time frame: 1 year
Evaluate the effectiveness of face to face training or e-learning training to use the patient-centered approach
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
AUBIN-AUGER M ISABELLE, MD, Pr principal investigator
COLLEGE DE LA MEDECINE GENERALE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Collège de la Médecine Générale, France at 1 site 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 4 inclusion and 4 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 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients screened positive using the patient-centered approach after training of face to face training or e-learning (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2019.