Back to resultsRandomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations (GPs)
Primary Purpose
Breast Cancer, Colorectal Cancer, Cervical Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Normal invitation
revised invitation signed by the coordinating doctor
Revised invitation signed by the attending physician
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring general practitioner, screening, participation, organized screening
Eligibility Criteria
Inclusion Criteria:
- Living in Indre-et-Loire (french territorial division 37)
- Be affiliated to the following three health insurance companies: CPAM (Caisse Primaire d'Assurance Maladie), MSA (Mutualité Sociale Agricole), or RSI (Régime social des Indépendants)
- Having declared (to health insurance company) an attending physician who has given its written consent to participate in the study
- Present no exclusion criterion to cancer screening ( for each one)
- Be old from 50 to 74 years (breast and colorectal cancer) or from 25 to 65 years (cervical cancer)
Exclusion Criteria:
Sites / Locations
- Centre de Coordination des Dépistages des Cancers (CCDC)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Experimental
Arm Label
1: standard invitation
2: Revised invitation
3 : revised invitation signed by the attending physician
Arm Description
Group 1: sending a standard invitation signed by the coordinating doctor (send by the structure responsible for organized screenings) Intervention : Normal invitation
Group 2: Sending a revised invitation ( text, layout) signed by the coordinating doctor (send by the structure responsible for organized screenings) Intervention : revised invitation signed by the coordinating doctor
Group 3: Sending a revised invitation signed by the attending physician (send by the structure responsible for organized screenings) Intervention : Revised invitation signed by the attending physician
Outcomes
Primary Outcome Measures
Evaluate the effect on the participation (of the population) in cancer screening of an intervention involving the general practitioner (integration of signature) in the invitation letters
The participation / non participation will be measured for each cancer screening (breast, colorectal and cervical) :
9 months after the invitation letters for breast and colorectal cancers
12 months after the invitation letters for cervical cancer
The participation rate is defined as the number of people having participated, divided by the total number of people in the group or subgroup considered.
Analysis by comparing the participation rates between groups (Group 1, Group 2 and Group 3) and sub-groups will be done.
Secondary Outcome Measures
Evaluate the effectiveness on the participation (of the population) of the use of a simplified and more focused communication in the invitation letters : comparison of the participation rates in arm 1 (normal invitation) and arm 2 (revised invitation)
Evaluate the effectiveness on the participation (of the population) of the two types of general practitioner signature (typed versus typed + handwritten) by comparing the participation rates between two sub-groups in the arm 3.
Cost-effectiveness of different strategies for each cancer screening (breast, colorectal and cervical) as measured by cost effectiveness ratio (total costs in Euros divided by total screened people)
Full Information
NCT ID
NCT02367001
First Posted
January 28, 2015
Last Updated
September 30, 2015
Sponsor
University Hospital, Tours
1. Study Identification
Unique Protocol Identification Number
NCT02367001
Brief Title
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations
Acronym
GPs
Official Title
Randomized Trial Evaluating the Effectiveness of a "Targeted Communication" With the General Practitioner Involvement in Cancer Screening Invitation Letters
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our goal is to evaluate, in France, the effectiveness (in terms of participation) of the general practitioner involvement (signature) and a more personalized communication in invitation letters to organized screening of breast, colorectal and cervical cancers.
The hypothesis on which this project is based is that communication is probably more effective if the "receiver" feels personally targeted by invitation letters (Dear Martin, I am writing ...) and if he knows "the issuer "(his general practitioner rather an unknown person).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Colorectal Cancer, Cervical Cancer
Keywords
general practitioner, screening, participation, organized screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
53978 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1: standard invitation
Arm Type
Other
Arm Description
Group 1: sending a standard invitation signed by the coordinating doctor (send by the structure responsible for organized screenings)
Intervention : Normal invitation
Arm Title
2: Revised invitation
Arm Type
Experimental
Arm Description
Group 2: Sending a revised invitation ( text, layout) signed by the coordinating doctor (send by the structure responsible for organized screenings)
Intervention : revised invitation signed by the coordinating doctor
Arm Title
3 : revised invitation signed by the attending physician
Arm Type
Experimental
Arm Description
Group 3: Sending a revised invitation signed by the attending physician (send by the structure responsible for organized screenings)
Intervention : Revised invitation signed by the attending physician
Intervention Type
Other
Intervention Name(s)
Normal invitation
Intervention Description
No modification and signed by the coordinating doctor as usual
Intervention Type
Other
Intervention Name(s)
revised invitation signed by the coordinating doctor
Intervention Description
Invitation with revised text and layout and signed by the coordinating doctor as usual
Intervention Type
Other
Intervention Name(s)
Revised invitation signed by the attending physician
Intervention Description
signature typed or typed + handwritten
Primary Outcome Measure Information:
Title
Evaluate the effect on the participation (of the population) in cancer screening of an intervention involving the general practitioner (integration of signature) in the invitation letters
Description
The participation / non participation will be measured for each cancer screening (breast, colorectal and cervical) :
9 months after the invitation letters for breast and colorectal cancers
12 months after the invitation letters for cervical cancer
The participation rate is defined as the number of people having participated, divided by the total number of people in the group or subgroup considered.
Analysis by comparing the participation rates between groups (Group 1, Group 2 and Group 3) and sub-groups will be done.
Time Frame
9 or 12 months after the invitation letters
Secondary Outcome Measure Information:
Title
Evaluate the effectiveness on the participation (of the population) of the use of a simplified and more focused communication in the invitation letters : comparison of the participation rates in arm 1 (normal invitation) and arm 2 (revised invitation)
Time Frame
9 or 12 months after the invitation letters
Title
Evaluate the effectiveness on the participation (of the population) of the two types of general practitioner signature (typed versus typed + handwritten) by comparing the participation rates between two sub-groups in the arm 3.
Time Frame
9 or 12 months after the invitation letters
Title
Cost-effectiveness of different strategies for each cancer screening (breast, colorectal and cervical) as measured by cost effectiveness ratio (total costs in Euros divided by total screened people)
Time Frame
9 or 12 months after the invitation letters
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Living in Indre-et-Loire (french territorial division 37)
Be affiliated to the following three health insurance companies: CPAM (Caisse Primaire d'Assurance Maladie), MSA (Mutualité Sociale Agricole), or RSI (Régime social des Indépendants)
Having declared (to health insurance company) an attending physician who has given its written consent to participate in the study
Present no exclusion criterion to cancer screening ( for each one)
Be old from 50 to 74 years (breast and colorectal cancer) or from 25 to 65 years (cervical cancer)
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken HAGUENOER
Organizational Affiliation
University Hospital of TOURS
Official's Role
Study Director
Facility Information:
Facility Name
Centre de Coordination des Dépistages des Cancers (CCDC)
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations
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