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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

France1 site
  • Département de Médecine Générale

    Paris, Idf, 75018

Other trials in France

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
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 groups in NCT03938623
Study groupRoleWhat they receive
TrainingTeaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
Receives: Other: Training
ControlGeneral Practitioners not using the patient-centered approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2019
  2. Study start24 Jan 2018
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

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)
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

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.

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