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Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? (Pagedocc2)

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Co-signed Letter
Control
Sponsored by
University of Paris 5 - Rene Descartes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Cancer, Screening, General Practitioner, Fecal Occult Blood Tests

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age : 50 to 74 years.
  • Not having answered the first two solicitations of ADECA75 to participate in screening for colorectal cancer

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).

Sites / Locations

  • Université Paris DescartesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Co-signed Letter

Arm Description

Patients receive by mail the materials needed for stool samples.

Outcomes

Primary Outcome Measures

Completion of Fecal Occult Blod Test
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).

Secondary Outcome Measures

Delays from receipt of the letter and the completion of the test.
Proportion of uninterpretable test.

Full Information

First Posted
January 18, 2011
Last Updated
January 18, 2011
Sponsor
University of Paris 5 - Rene Descartes
Collaborators
Adeca 75, Société de Formation Thérapeutique du Généraliste, Hotel Dieu Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01279330
Brief Title
Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?
Acronym
Pagedocc2
Official Title
Does the Invitation by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening? A Cluster Randomised Controlled Study.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Paris 5 - Rene Descartes
Collaborators
Adeca 75, Société de Formation Thérapeutique du Généraliste, Hotel Dieu Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The propose of this study is to assess the effect of general practitioner's involvement in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, Screening, General Practitioner, Fecal Occult Blood Tests

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1569 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients receive by mail the materials needed for stool samples.
Arm Title
Co-signed Letter
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Co-signed Letter
Intervention Description
Patients receive a personalized stimulus letter co-signed by their general practitioner and the medical coordinator of ADECA.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No intervention (Patients receive by mail the materials needed for stool samples).
Primary Outcome Measure Information:
Title
Completion of Fecal Occult Blod Test
Description
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).
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Delays from receipt of the letter and the completion of the test.
Time Frame
7 months
Title
Proportion of uninterpretable test.
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age : 50 to 74 years. Not having answered the first two solicitations of ADECA75 to participate in screening for colorectal cancer 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serge Gilberg
Phone
01 44 41 23 63
Email
gilberg@parisdescartes.fr
Facility Information:
Facility Name
Université Paris Descartes
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barthe
Phone
01 44 41 23 63
Email
juliette.barthe@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Does the Recall by the General Practitioner Improve Patients' Participation in Colorectal Cancer Screening?

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