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

NCT05164874 | Unknown

• 1 other identifier: UCaenNormandie
• Study Type: interventional
• Target: 91,982
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

breast cancer screening; mobile mammography unit; social and territorial inequalities; randomized cluster trial

Outcome Measures

Primary Outcomes (4)

• Aggregated breast cancer screening participation rate 3 months after the last invitation

  Participation rate will be measure at area level and compare between intervention and control arm.

  3 months after the last invitation at the end of the two years of the intervention

• Individual breast cancer screening participation rate 3 months after the last invitation

  It will also be assessed at indivdual level with multilevel logistic regression

  3 months after the last invitation at the end of the two years of the intervention

• Impact of the mobile unit on social inequalities in screening participation

  Impact of the mobile mammography unit on social inequalities will be assessed by comparing intervention and control arm. Social statut is measure with an ecological deprivation index

  3 months after the last invitation at the end of the two years of the intervention

• Impact of the mobile unit on territorial inequalities in screening participation

  impact of the mobile mammography unit territorial inequalities will be assessed by comparing intervention and control arm. The distance to the radiologiste center will be used as territorial mesure

  3 months after the last invitation at the end of the two years of the intervention

Secondary Outcomes (5)

• Informed choice to breast cancer screening for participating women

  through study completion, an average of 3 month

• Informed choice to breast cancer screening for non-participating women

  Women will be considered as "non participating" 18 month after the invitation

• Satisfaction to mammography

  through study completion, an average of 3 month

• Com-B Model Evaluation for participating women

  through study completion, an average of 3 month

• Com-B Model Evaluation for non-participating women

  Women will be considered as "non participating" 18 month after the invitation

Study Arms (2)

Intervention

EXPERIMENTAL

Women will receive a proposition for an appointment at the MMU in complement to the current screening invitation, keeping the choice of their place of screening. Women will also receive the timetable of prevention actions with the invitation to participate in screening.

Device: Mobile Mammography Unit

Control

NO INTERVENTION

No change from the usual breast cancer screening organization

Interventions

Mobile Mammography Unit DEVICE

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

Intervention

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women eligible to breast cancer screening campaign : aged 50 to 74 years, and with the only risk of breast cancer being age. The previous screening mammography dating from 22 months

You may not qualify if:

• outside the ages
• with specific risk of breast cancer

Sponsors & Collaborators

• Université de Caen Normandie: lead
• National Cancer Institute, France: collaborator
• Regional health agency, Normandy France: collaborator
• Pink ribbon (Ruban Rose, France): collaborator
• Normandy regional cancer screening coordination center: collaborator
• Departmental councils: collaborator

Study Sites (1)

Normandy

Caen, Normandy, 14000, France

Location

Related Publications (1)

• Guillaume E, Rollet Q, Launay L, Beuriot S, Dejardin O, Notari A, Crevel E, Benhammouda A, Verzaux L, Quertier MC, Launoy G. Evaluation of a mobile mammography unit: concepts and randomized cluster trial protocol of a population health intervention research to reduce breast cancer screening inequalities. Trials. 2022 Jul 8;23(1):562. doi: 10.1186/s13063-022-06480-w.

  PMID: 35804417 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Elodie Guillaume, PhD

  Université de Caen Normandie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Epidemiology and Public Health

Model Details: This intervention will be conducted as a prospective randomized controlled cluster trial.The cluster of the study is an aggregation of géographical areas. It was done according to the travel time to the radiology centres, the most distant areas has been selected and then merged with neighbouring areas, still by distance run, until reaching areas of the expected population size. This except size is around 100 women. Expecting a 40% participation to the mobile unit, we will achieve 32 to 48 mammograms daily. A randomization in parallel group have been perform to constitute the intervention arm and the control arm.

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 21, 2021
• Study Start: February 14, 2022
• Primary Completion: February 1, 2024
• Study Completion: September 1, 2024
• Last Updated: December 21, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data concerning participation, place of participation, date, distance and socioeconomic status will be anonimously analysed after the two years.

Locations

FR (1)