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Influence of a Brief Intervention on CRC Screening (Hem-FMG)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
GPs communication skills and CRC screening
Sponsored by
University Paris 7 - Denis Diderot
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring cancer, CRC screening, communication

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion of GPs practices: All GPs practices of the Val d'Oise department in France were eligible to participate GPs using complementary therapies occasionally were allowed to participate

Exclusion Criteria:

Exclusion of GPs practices : practices were excluded when doctors used exclusively complementary therapies (acupuncture therapy, homeopathy….)

-

Sites / Locations

  • University Paris Diderot

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

control group

intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

GPs with a participation rate over 65%
the number of GPs who reached a patients participation rate of 65% during the study period because of the desirable level of uptake rate over 65% defined by the European guidelines of quality assurance in colorectal cancer screening
GPs participation rate over 45%
The number of Gps who reached a participation rate of 45% because of the acceptable level of uptake defined by the same guidelines , the number of gFOBT delivered by GPs during study period,

Full Information

First Posted
March 8, 2013
Last Updated
December 10, 2013
Sponsor
University Paris 7 - Denis Diderot
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1. Study Identification

Unique Protocol Identification Number
NCT02012829
Brief Title
Influence of a Brief Intervention on CRC Screening
Acronym
Hem-FMG
Official Title
Brief Intervention to Improve Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Paris 7 - Denis Diderot

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed Description
a cluster randomized controlled parallel groups study was conducted in the Val d'Oise department in France All practices of the Val d'Oise department were eligible to participate. Among 585 practices, an independent biostatistician randomized 50 practices per arm in October 2011 according to a computer generated randomization list.Two team members phone called all the GPS of the randomized practices. GPs from practices in the control group are asked to continue their usual care, as if they were not participating in this trial. GPs of both groups had to send their patients list to the research team to calculate their eligible population. They were also asked to list all the gFOBT delivered during the six months period of the study. GPs of the intervention group received a four hours educational training focused on patients' centered care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
cancer, CRC screening, communication

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
intervention
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
GPs communication skills and CRC screening
Intervention Description
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.
Primary Outcome Measure Information:
Title
participation rate of patients for CRC screening
Description
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
Time Frame
7 months
Secondary Outcome Measure Information:
Title
GPs with a participation rate over 65%
Description
the number of GPs who reached a patients participation rate of 65% during the study period because of the desirable level of uptake rate over 65% defined by the European guidelines of quality assurance in colorectal cancer screening
Time Frame
7 months
Title
GPs participation rate over 45%
Description
The number of Gps who reached a participation rate of 45% because of the acceptable level of uptake defined by the same guidelines , the number of gFOBT delivered by GPs during study period,
Time Frame
7 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion of GPs practices: All GPs practices of the Val d'Oise department in France were eligible to participate GPs using complementary therapies occasionally were allowed to participate Exclusion Criteria: Exclusion of GPs practices : practices were excluded when doctors used exclusively complementary therapies (acupuncture therapy, homeopathy….) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle AUGER, Professor
Organizational Affiliation
University Paris Diderot
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Paris Diderot
City
Paris
ZIP/Postal Code
75018
Country
France

12. IPD Sharing Statement

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Influence of a Brief Intervention on CRC Screening

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