Influence of a Brief Intervention on CRC Screening

Colorectal Cancer Clinical Trial

— Hem-FMG  

Official title:

Brief Intervention to Improve Colorectal Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012829
• Other study ID #: 2011/19NI
• Status: Completed
• Phase: N/A
• First received: March 8, 2013
• Last updated: December 10, 2013
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2013
• Source: University Paris 7 - Denis Diderot
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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….)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• GPs communication skills and CRC screening
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.

Locations

Country	Name	City	State
France	University Paris Diderot	Paris

Sponsors (1)

Lead Sponsor	Collaborator
University Paris 7 - Denis Diderot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	7 months	No
Secondary	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,	7 months	No