NCT02012829

Brief Summary

Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC) screening in France The qualitative data indicated that improvement was needed in patient-centered communication. Educational material was developed based on these triangulated data with two different scenarios to improve communication with patients: one for a compliant patient, another for a non compliant patient The hypothesis is that a brief intervention on GPs can improve the patients' participation rate to colorectal screening Method : cluster randomized control trial (cluster unit : GPs practices) With a brief intervention on a randomized population of GPs in the district of Val d'Oise Inclusion criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal mass screening

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2013

Completed
9 months until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

7 months

First QC Date

March 8, 2013

Last Update Submit

December 10, 2013

Conditions

Keywords

cancer, CRC screening, communication

Outcome Measures

Primary Outcomes (1)

  • participation rate of patients for CRC screening

    Comparison of the participation rate for patients for CRC screening among GPs belonging to the intervention group versus the participation rate for patients for CRC screening among GPs belonging to the control group

    7 months

Secondary Outcomes (2)

  • GPs with a participation rate over 65%

    7 months

  • GPs participation rate over 45%

    7 months

Study Arms (2)

control group

NO INTERVENTION

GPs from practices in the control group are asked to continue their usual care, as if they were not participating in this trial. They had to send their patients list to the research team to calculate their eligible population. They were also asked to list all the gaiac Fecal occult blood test ( gFOBT) delivered during the six months period of the study.

intervention

ACTIVE COMPARATOR

GPs communication skills and CRC screening :the intervention was a four hours educational training for GPs of the intervention group focused on communication skills with a patients' centered care approach to improve patients participation at CRC screening

Behavioral: GPs communication skills and CRC screening

Interventions

GPs of the intervention group received a four hours educational training focused on patients' centered care to improve GPs communication skills and enhance patients'participation in CRC mass screening . Triangulation of all qualitative data was performed in order to develop educational material and training based on the six components of the Patient-Centered Clinical Method . Two different scenarios were developed: one for a compliant patient, another for a non-compliant patient. Two videos were made with doctor and simulated patient. Interactive methods were used to elaborate educational training including role playing, the presentation of the video followed by an interactive discussion.

intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Paris Diderot

Paris, 75018, France

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasmsCommunication

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBehavior

Study Officials

  • Isabelle AUGER, Professor

    University Paris Diderot

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 8, 2013

First Posted

December 16, 2013

Study Start

December 1, 2011

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations