CClinicalTrials.gg
Status unknownNCT03938623FORCEPSUpdated May 6, 2019

Teaching General Practitioners to Use the Patient-centered Approach When Suggesting Colorectal Cancer Screening

An observational study in Colorectal Cancer, sponsored by Collège de la Médecine Générale, France. Status unknown at 1 site in France. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2019-05-06.

Sponsored by Collège de la Médecine Générale, France · Observational

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
274
Ages
50 Years to 74 Years
Sex
All
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Study 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.

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
02

Conditions studied

  • Colorectal Cancer

Keywords

  • colorectal cancer
  • general practitioners
  • the patient-centered approach
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 274 is close to the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

This is the only study on the registry with Collège de la Médecine Générale, France as lead sponsor.

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
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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
274 participants (actual)
Patient registry
No

Groups and cohorts

  • Training

    Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening

    Other: Training

  • Control

    General Practitioners not using the patient-centered approach

Interventions

  • OtherTraining

    Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening

    Also known as: The patient-centered approach

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year

07

Study locations

1 site
  • Département de Médecine Générale
    Paris, Idf 75018, France
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03938623
Lead sponsor
Collège de la Médecine Générale, France
Collaborators
National Cancer Institute, France
Responsible party
Sponsor
First posted
May 6, 2019
Start date
Jan 24, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
May 6, 2019

Study contacts

AUBIN-AUGER M ISABELLE, MD, Pr
principal investigator · COLLEGE DE LA MEDECINE GENERALE

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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