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

NCT02367001 | Completed

• 1 other identifier: INCA-P3644-KH-GPs
• Study Type: interventional
• Target: 53,978
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Colorectal Cancer; Cervical Cancer

Keywords

general practitioner; screening; participation; organized screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

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

Other: Normal invitation

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

Other: revised invitation signed by the coordinating doctor

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

Other: Revised invitation signed by the attending physician

Interventions

Normal invitation OTHER

No modification and signed by the coordinating doctor as usual

1: standard invitation

revised invitation signed by the coordinating doctor OTHER

Invitation with revised text and layout and signed by the coordinating doctor as usual

2: Revised invitation

Revised invitation signed by the attending physician OTHER

signature typed or typed + handwritten

3 : revised invitation signed by the attending physician

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Be old from 50 to 74 years (breast and colorectal cancer) or from 25 to 65 years (cervical cancer)

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

Centre de Coordination des Dépistages des Cancers (CCDC)

Tours, 37044, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ken HAGUENOER

  University Hospital of TOURS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 20, 2015
• Study Start: February 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-02

Locations

FR (1)