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OpenTrials
Completed

NCT Number: NCT02012829

Influence of a Brief Intervention on CRC Screening

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

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Key information

Conditions

Colorectal Cancer Behavior Colonic Diseases Colorectal Neoplasms Communication Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Paris Diderot

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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….)

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Treatment and study plan

GPs communication skills and CRC screening

Behavioral

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 outcomes

  1. participation rate of patients for CRC screening

    Time frame: 7 months

    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 outcomes

  1. GPs with a participation rate over 65%

    Time frame: 7 months

    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

  2. GPs participation rate over 45%

    Time frame: 7 months

    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,

Sponsors and collaborators

Lead sponsor

University Paris 7 - Denis Diderot

Other

Registry information

Official study title

Brief Intervention to Improve Colorectal Cancer Screening

Acronym: Hem-FMG

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 16, 2013
Registry last updated
Dec 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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