Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations

Study Overview
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Brief Summary
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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).

Official Title
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Randomized Trial Evaluating the Effectiveness of a Targeted Communication With the General Practitioner Involvement in Cancer Screening Invitation Letters

Conditions
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Breast Cancer, Colorectal Cancer, Cervical Cancer

Intervention / Treatment
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* Other: Normal invitation
* Other: revised invitation signed by the coordinating doctor
* Other: Revised invitation signed by the attending physician


Participation Criteria
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Eligibility Criteria
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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:

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1: standard invitation<br>Group 1: sending a standard invitation signed by the coordinating doctor (send by the structure responsible for organized screenings) Intervention : Normal invitation | Other: Normal invitation<br>* No modification and signed by the coordinating doctor as usual<br>|
| Experimental: 2: Revised invitation<br>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 | Other: revised invitation signed by the coordinating doctor<br>* Invitation with revised text and layout and signed by the coordinating doctor as usual<br>|
| Experimental: 3 : revised invitation signed by the attending physician<br>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 | Other: Revised invitation signed by the attending physician<br>* signature typed or typed + handwritten<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 9 or 12 months after the invitation letters | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 9 or 12 months after the invitation letters | 
| 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. |  | 9 or 12 months after the invitation letters | 
| 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) |  | 9 or 12 months after the invitation letters | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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general practitioner, screening, participation, organized screening