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.
| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer | Other: Training |
Show detailed description
| Study Type : | Observational |
| Actual Enrollment : | 274 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening |
| Actual Study Start Date : | January 24, 2018 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2020 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Training
Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
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Other: Training
Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
Other Name: The patient-centered approach
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Control
General Practitioners not using the patient-centered approach
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| Ages Eligible for Study: | 50 Years to 74 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
| France | |
| Département de Médecine Générale | |
| Paris, Idf, France, 75018 | |
| Principal Investigator: | AUBIN-AUGER M ISABELLE, MD, Pr | COLLEGE DE LA MEDECINE GENERALE |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | April 25, 2019 | ||||
| First Posted Date | May 6, 2019 | ||||
| Last Update Posted Date | May 6, 2019 | ||||
| Actual Study Start Date | January 24, 2018 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening | ||||
| Official Title | Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening | ||||
| Brief 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 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. |
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| 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 ;
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| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| 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. | ||||
| Condition | Colorectal Cancer | ||||
| Intervention | Other: Training
Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
Other Name: The patient-centered approach
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Actual Enrollment |
274 | ||||
| Original Actual Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2020 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 50 Years to 74 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03938623 | ||||
| Other Study ID Numbers | 2016IAN913 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Collège de la Médecine Générale, France | ||||
| Study Sponsor | Collège de la Médecine Générale, France | ||||
| Collaborators | National Cancer Institute, France | ||||
| Investigators |
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| PRS Account | Collège de la Médecine Générale, France | ||||
| Verification Date | April 2019 | ||||