NCT06180746

Brief Summary

The investigators are conducting a longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design. The ECEMSo study aims to identify the impact of health mediation on fostering healthcare utilization, in particular organized cancer screening uptake, by underserved populations living in informal housing in France.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,041

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

December 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

9 months

First QC Date

December 4, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

Healthcare utilizationHealth mediationCancer screeningComplex interventionrealist evaluationstudy protocolunderserved populations

Outcome Measures

Primary Outcomes (3)

  • Impact of health mediation on healthcare utilization in people living in informal housing (PLIH) in France

    The difference in healthcare utilization by PLIH between groups 2 and group 3

    At six months follow-up

  • Impact of the intervention on people living in informal housing (PLIH) uptake of organized cancer screening

    The difference in organized cancer screening uptake (breast cancer, colorectal cancer, cervical cancer) between PLIH in group 1 and PLIH in group 2

    At six months follow-up

  • Health mediation conditions required to foster utilization of healthcare services among people living in informal housing (PLIH) in France

    The difference in organized cancer screening uptake (at 2 years since diagnosis for breast cancer and colorectal cancer, at 3 years since diagnosis for cervical cancer) between PLIH in group 1 and people living in informal housing in group 3

    At six months follow-up

Study Arms (3)

ECEMSo intervention

EXPERIMENTAL

This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group

Behavioral: Knowledge mobilization to facilitate the structuring of health mediation

Group 2 : No intervention

NO INTERVENTION

This group is composed of health mediators, the people living in informal housing they support and stakeholders. The ECEMSo intervention will not be implemented in this group.

Group 3 : No intervention

NO INTERVENTION

This group is composed of health workers, social workers, the people living in informal housing they support and stakeholders. The ECEMSo intervention will be implemented in this group.

Interventions

The ECEMSo intervention involves knowledge mobilization to facilitate the structuring of health mediation throughout French territory, and the development of a co-designed effective action plan to facilitate cancer screening uptake by people living in informal housing. The action plan will, consider territorial specificities at the regional level. The ECEMSo project team will organize a seminar and three workshops. The aim of the seminar and workshops is to mobilize knowledge to facilitate i) the structuring of health mediation in the regions, and ii) the development of an action plan with health mediators and other stakeholders to foster organized cancer screenings uptake by underserved people. This action plan must match with the needs of people living in informal housing, and must be coordinated, suitable and feasible to implement, in terms of knowledge about people living in informal housing specificities and specific local collaborations

ECEMSo intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living on the streets, in a shanty house, squat or caravan
  • Living in an area covered by one of care structures participating in the ECEMSo study
  • Being over 18 years old
  • Being able to understand the detailed information provided about the ECEMso study

You may not qualify if:

  • Suffering from cognitive and/or psychiatric disorders
  • Being under guardianship or curatorship
  • Health mediators, heal workers, socials workers
  • Being a health mediator, a health worker or a social worker belonging to one of the study's participation care structures
  • Providing support to people living in informal housing
  • Stakeholder:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Negotiating

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Judith Martin-Fernandez, PhD

    Equipe Mérisp/PHARES, INSERM, BPH, U1219, University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Martin-Fernandez, PhD

CONTACT

Garance Perret

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: longitudinal mixed-method intervention study with a multi-center, multi-case explanatory sequential design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 22, 2023

Study Start

December 15, 2023

Primary Completion

September 15, 2024

Study Completion

September 15, 2024

Last Updated

December 22, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share