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A Randomized Cluster Trial to Evaluate a Mobile Mammography Unit in Breast Cancer Screening in France (Mammobile)

NCT05164874 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91982

Last updated 2021-12-21

No results posted yet for this study

Summary

Organized breast cancer screening (OBCS) has been implemented nationwide since 2004 inFrance, but the participation rate remains low (51%) and inequities in participation were reported. Strategies as mobile mammography units could be effective to increase participation in OBCS and reduce inequities, especially in underserved areas in regard to this screening. Our main objective is to evaluate this device and to identify how to incorporate a mobile unit in the OBCS with a view to tackle territorial inequities in OBCS participation. The project will be conducted as a randomized controlled cluster trial in 2022-2024, in remote areas of 4 French departments. The main intervention is to propose an appointment at the mobile unit in complement to the current OBCS in these remote areas. In addition, few weeks before this intervention, local actors will carry out actions to promote OBCS with mobile unit specific information tools. This randomized controlled trial will provide a high level of evidence in assessing the mobile unit effects on participation and inequities.

Conditions

Interventions

DEVICE

Mobile Mammography Unit

The main intervention will be a proposition for an appointment at the MMU in complement to the current OBCS

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Regional health agency, Normandy France

    collaborator UNKNOWN

  • Pink ribbon (Ruban Rose, France)

    collaborator UNKNOWN

  • Normandy regional cancer screening coordination center

    collaborator UNKNOWN

  • Departmental councils

    collaborator UNKNOWN

  • Université de Caen Normandie

    lead OTHER

Principal Investigators

  • Elodie Guillaume, PhD · Université de Caen Normandie

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-14
Primary Completion
2024-02-29
Completion
2024-09-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05164874 on ClinicalTrials.gov