Colorectal CancerEarly Phase 1NCT01364454
General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening
A Early Phase 1 study testing Eligible patients' paper-based reminder in people with Colorectal Cancer, run by Paris 12 Val de Marne University at 1 site in France.
Trial summary
Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence that it reduces mortality from CRC and that it's cost-effective. In France, there is a national CRC screening programme inviting people aged 50-74 years by mail to consult their General Practitioner (GP) for a free on charge… Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Eligible patients' paper-based reminder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,140 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jun 2011
- Phase
- Early Phase 1
- 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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Practitioner (GP)
- exercising in the Val de Marne (French department of the suburb of Paris)
- volunteered to participate at the study
- Patient
- living in the Val de Marne (French department of the suburb of Paris)
- having declared a 'preferred GP' exercising in the Val de Marne to the main statutory health insurance scheme ("régime général")
- being eligible for colorectal cancer screening (aged 50 to 74 years, not excluded and having not proceed yet to the screening)
- having consulted his 'preferred GP', whatever the reason, during the study period
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site
Département Universitaire d'Enseignement et de Recherche en Médecine Générale
Créteil, 94000
About this study
Official title: Effect of Eligible Patients Paper-based Reminder for General Practitioners on Colorectal Cancer Screening Participation
Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence that it reduces mortality from CRC and that it's cost-effective. In France, there is a national CRC screening programme inviting people aged 50-74 years by mail to consult their General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two years. Participation is a key factor for the screening programs success. High levels of screening uptake and the continued participation to regular screening must be achieved and maintained in the targeted population if the enormous potential of CRC screening is to be realised. Screening rates of various international programs vary widely (20-52%) and the participation is insufficient in the most settings. Therefore, a better understanding of facilitating and hindering factors of patient participation can guide interventions to improve CRC screening rates. They include patients and physicians' factors. One issue is about GPs practice. GP involvement has been shown to improve the participation in the CRC screening. This study aims to assess the effectiveness of an intervention targeting GPs to increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in providing every four months to the experimental group a list of their patients who are eligible but did not proceed yet to the screening. In both groups, patient participation in the screening will be measured at the end of the study.
- Conditions
- Colorectal Cancer
- Being tested
- Eligible patients' paper-based reminder
- Keywords
- Colorectal Cancer Screening, Faecal Occult Blood test, General Practitioners Involvement, Patient's Participation, Reminder
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eligible patients' paper-based reminderOther
Providing to the general practitioners every four months a list of their patients who are eligible for colorectal cancer screening but did not proceed yet and were not excluded for medical reason
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients' paper-based reminder | Experimental | Not described Receives: Other: Eligible patients' paper-based reminder |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's participation to colorectal cancer screening program
Patient's status with colorectal cancer screening program to 15th june 2011 with two modalities
- Update: completion of Faecal Occult Blood test or exclusion for medical reason within the duration of the study (The medical exclusions of the program are a personal or family history of Colorectal cancer, Crohn's disease, hemorrhagic rectocolitis, or hereditary nonpolyposis colorectal cancer, a colonoscopy undergone in the 5 previous years or a Fecal Occult Blood test undergone in the 2 previous years)
- Not update
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
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
- Early Phase 1
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8,140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paris 12 Val de Marne University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julien Le Breton, Paris 12 Val de Marne University
- Investigators
- Julien Le Breton, MD, MPH, Principal investigator, DUERMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364454
- Sponsor's protocol ID
- DUERMG
- Status last verified
- Aug 2016
- First submitted
- 31 May 2011
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eligible Patients Paper-based Reminder for General Practitioners on Colorectal Cancer Screening Participation
- ClinicalTrials.gov ID
- NCT01364454
- Acronym / sponsor ID
- DUERMG
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer Screening, Faecal Occult Blood test, General Practitioners Involvement, Patient's Participation, Reminder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,140 participants (actual)
- Lead sponsor
- Paris 12 Val de Marne UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Jun 2011 (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.
Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence that it reduces mortality from CRC and that it's cost-effective. In France, there is a national CRC screening programme inviting people aged 50-74 years by mail to consult their General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two years. Participation is a key factor for the screening programs success. High levels of screening uptake and the continued participation to regular screening must be achieved and maintained in the targeted population if the enormous potential of CRC screening is to be realised. Screening rates of various international programs vary widely (20-52%) and the participation is insufficient in the most settings. Therefore, a better understanding of facilitating and hindering factors of patient participation can guide interventions to improve CRC screening rates. They include patients and physicians' factors. One issue is about GPs practice. GP involvement has been shown to improve the participation in the CRC screening. This study aims to assess the effectiveness of an intervention targeting GPs to increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in providing every four months to the experimental group a list of their patients who are eligible but did not proceed yet to the screening. In both groups, patient participation in the screening will be measured at the end of the study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eligible patients' paper-based reminder | Experimental | Other: Eligible patients' paper-based reminder |
| Control group | No intervention | – |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- General Practitioner (GP)
- Patient
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Eligible patients' paper-based reminderProviding to the general practitioners every four months a list of their patients who are eligible for colorectal cancer screening but did not proceed yet and were not excluded for medical reason | Other | Eligible patients' paper-based reminder |
Primary outcome
Patient's participation to colorectal cancer screening program
Time frame: 1 year
Patient's status with colorectal cancer screening program to 15th june 2011 with two modalities 1. Update: completion of Faecal Occult Blood test or exclusion for medical reason within the duration of the study (The medical exclusions of the program are a personal or family history of Colorectal cancer, Crohn's disease, hemorrhagic rectocolitis, or hereditary nonpolyposis colorectal cancer, a colonoscopy undergone in the 5 previous years or a Fecal Occult Blood test undergone in the 2 previous years) 2. Not update
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 19 Aug 2016.
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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.
Julien Le Breton, MD, MPH principal investigator
DUERMG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Eligible patients' paper-based reminder in people with Colorectal Cancer, run by Paris 12 Val de Marne University 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 8 inclusion and 0 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 19 Aug 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient's participation to colorectal cancer screening program (time frame: 1 year). 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 19 Aug 2016.