General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | May 31, 2011 | ||||
| Last Updated Date | June 1, 2011 | ||||
| Start Date ICMJE | June 2010 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Patient's participation to colorectal cancer screening program [ Time Frame: 1 year ] [ Designated as safety issue: No ] Patient's status with colorectal cancer screening program to 15th june 2011 with two modalities
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01364454 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening | ||||
| Official Title ICMJE | Effect of Eligible Patients Paper-based Reminder for General Practitioners on Colorectal Cancer Screening Participation | ||||
| Brief 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 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | Colorectal Cancer | ||||
| Intervention ICMJE | Other: Eligible patients' paper-based reminder
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 |
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| Study Arm (s) | Experimental: Eligible patients' paper-based reminder
Intervention: Other: Eligible patients' paper-based reminder |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 8140 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: |
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| Gender | Both | ||||
| Ages | 50 Years to 74 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | France | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01364454 | ||||
| Other Study ID Numbers ICMJE | DUERMG | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Julien Le Breton / PI, LIC EA4393 / DUERMG | ||||
| Study Sponsor ICMJE | Paris 12 Val de Marne University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Paris 12 Val de Marne University | ||||
| Verification Date | May 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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