Clinical trial NCT02367001: Randomized Trial Evaluating the Effectiveness of the General Practitioner Involvement in Cancer Screening Invitations
Official title: Randomized Trial Evaluating the Effectiveness of a "Targeted Communication" With the General Practitioner Involvement in Cancer Screening Invitation Letters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Cervical Cancer
Keywords: general practitioner
screening
participation
organized screening
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 53978
Sex: ALL
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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).


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:

Primary outcomes:
measure: 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
timeFrame: 9 or 12 months after the invitation letters
Secondary outcomes:
measure: 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)
timeFrame: 9 or 12 months after the invitation letters
measure: 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.
timeFrame: 9 or 12 months after the invitation letters
measure: 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)
timeFrame: 9 or 12 months after the invitation letters
Other outcomes:
Locations:
city: Tours
country: France
facility: Centre de Coordination des Dépistages des Cancers (CCDC)
Study officials:
affiliation: University Hospital of TOURS
name: Ken HAGUENOER
role: STUDY_DIRECTOR
References: