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

Breast Cancer Clinical Trial

— GPs  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367001
• Other study ID #: INCA-P3644-KH-GPs
• Status: Completed
• Phase: N/A
• First received: January 28, 2015
• Last updated: September 30, 2015
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: February 2015
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Conseil National de l'Ordre des MédecinsFrance: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53978
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 74 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Cervical Cancer
• Colorectal Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• Normal invitation
No modification and signed by the coordinating doctor as usual
• revised invitation signed by the coordinating doctor
Invitation with revised text and layout and signed by the coordinating doctor as usual
• Revised invitation signed by the attending physician
signature typed or typed + handwritten

Locations

Country	Name	City	State
France	Centre de Coordination des Dépistages des Cancers (CCDC)	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No