NCT03938623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
274

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 24, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 6, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

April 25, 2019

Last Update Submit

May 2, 2019

Conditions

Keywords

colorectal cancergeneral practitionersthe patient-centered approach

Outcome Measures

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

    1 year

Study Arms (2)

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

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

Also known as: The patient-centered approach
Training

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Département de Médecine Générale

Paris, Idf, 75018, France

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • AUBIN-AUGER M ISABELLE, MD, Pr

    COLLEGE DE LA MEDECINE GENERALE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 6, 2019

Study Start

January 24, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

May 6, 2019

Record last verified: 2019-04

Locations