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Clinical Trials/NCT02367001
NCT02367001CompletedNot Applicable

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

University Hospital, Tours1 site in 1 country53,978 target enrollmentStarted: February 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
53,978
Locations
1
Primary Endpoint
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

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
Single (Participant)

Eligibility Criteria

Ages
25 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Arms & Interventions

1: standard invitation

Other

Group 1: sending a standard invitation signed by the coordinating doctor (send by the structure responsible for organized screenings)

Intervention : Normal invitation

Intervention: Normal invitation (Other)

2: Revised invitation

Experimental

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

Intervention: revised invitation signed by the coordinating doctor (Other)

3 : revised invitation signed by the attending physician

Experimental

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: Revised invitation signed by the attending physician (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • 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)
  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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