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

September 30, 2015 updated by: University Hospital, Tours

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53978

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Tours, France, 37044
        • Centre de Coordination des Dépistages des Cancers (CCDC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1: standard invitation

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
No modification and signed by the coordinating doctor as usual
Experimental: 2: Revised 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
Other: revised invitation signed by the coordinating doctor
Invitation with revised text and layout and signed by the coordinating doctor as usual
Experimental: 3 : revised invitation signed by the attending physician

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
signature typed or typed + handwritten

What is the study measuring?

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
Time Frame: 9 or 12 months after 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
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)
Time Frame: 9 or 12 months after the invitation letters
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.
Time Frame: 9 or 12 months after the invitation letters
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)
Time Frame: 9 or 12 months after the invitation letters
9 or 12 months after the invitation letters

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Study Director: Ken HAGUENOER, University hospital of Tours

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 20, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCA-P3644-KH-GPs

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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