- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01279278
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? (Pagedocc1)
January 18, 2011 updated by: University of Paris 5 - Rene Descartes
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.
The propose of this study is to assess the effect of general practitioner's involvement on first patients' solicitation in screening for colorectal cancer by testing for faecal occult blood (FOBT).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
2700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Serge Gilberg
- Phone Number: 01 44 41 23 63
- Email: gilberg@parisdescartes.fr
Study Locations
-
-
Ile de France
-
Paris, Ile de France, France, 75014
- Recruiting
- Université Paris Descartes
-
Contact:
- Barthe
- Phone Number: 01 44 41 23 63
- Email: juliette.barthe@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged : 50 to 74 years.
- Not having ever been invited to participate in colorectal screening.
Exclusion Criteria:
- Patients who have a Fecal Occult Blood Test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from ADECA).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
Patients receive classical letter signed by the coordinator doctor of ADECA
|
Experimental: Co-signed Letter
|
Patients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of Fecal Occult Blod Test
Time Frame: 7 months
|
Increased number of patients who completed the test for faecal occult blood following the first solicitation with the letter co-signed by general practitioner, compared with the conventional solicition(including replies exclusions).
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure the impact of co-signing on deadline for completion of the test after the mailing.
Time Frame: 7 months
|
7 months
|
Compare the proportion of uninterpretable tests.
Time Frame: 7 months
|
7 months
|
Compare the rate of completion of colonoscopy after a positive test (information received by ADECA in the follow-up), according to the specifications.
Time Frame: 7 months
|
7 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
April 1, 2011
Study Completion (Anticipated)
April 1, 2011
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
January 19, 2011
Last Update Submitted That Met QC Criteria
January 18, 2011
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAGEDOCC1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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