Colorectal CancerHem-FMGNCT02012829
Influence of a Brief Intervention on CRC Screening
A study testing GPs communication skills and CRC screening in people with Colorectal Cancer, run by University Paris 7 - Denis Diderot at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- GPs communication skills and CRC screening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Exclusion of GPs practices : practices were excluded when doctors used exclusively complementary therapies (acupuncture therapy, homeopathy….)
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brief Intervention to Improve Colorectal Cancer 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
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- GPs communication skills and CRC screening
- Keywords
- cancer, CRC screening, communication
- Medical subject headings
- Colorectal Neoplasms, Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPs communication skills and CRC screeningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: GPs communication skills and CRC screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 months
Secondary outcomes (2)
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
Measured: 7 months
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,
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle AUGER, University Paris 7 - Denis Diderot
- Investigators
- Isabelle AUGER, Professor, Principal investigator, University Paris Diderot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012829
- Sponsor's protocol ID
- 2011/19NI
- Acronym
- Hem-FMG
- Status last verified
- Dec 2013
- First submitted
- 8 Mar 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention to Improve Colorectal Cancer Screening
- ClinicalTrials.gov ID
- NCT02012829
- Acronym / sponsor ID
- Hem-FMG / 2011/19NI
- Conditions
- Colorectal Cancer
- Keywords
- cancer, CRC screening, communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: GPs communication skills and CRC screeningGPs 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Exclusion of GPs practices : practices were excluded when doctors used exclusively complementary therapies (acupuncture therapy, homeopathy….)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPs communication skills and CRC screeningGPs 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. | Behavioural | intervention |
Primary outcome
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
2 secondary outcomes
GPs with a participation rate over 65%
Time frame: 7 months
GPs participation rate over 45%
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle AUGER, Professor principal investigator
University Paris Diderot
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GPs communication skills and CRC screening in people with Colorectal Cancer, run by University Paris 7 - Denis Diderot at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
participation rate of patients for CRC screening (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.