Evaluating a Health Literacy Intervention to Improve Colorectal Cancer Screening in Underserved Areas

NCT04631692 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1025

Last updated 2025-04-02

No results posted yet for this study

Summary

The aim of this project is to assess the impact of a health literacy (HL) intervention combining HL and CRC screening training for general practitioners with a short brochure and video targeting eligible patients to increase CRC screening and other secondary outcomes in four underserved geographic areas in France. The investigators will use a two-arm randomized controlled cluster trial at 8 clusters (2 per area) primarily serving underserved populations across 4 geographic areas in France with 32 primary care physicians and 1024 patients recruited.

Conditions

  • Colorectal Cancer Screening

Interventions

BEHAVIORAL

Health literacy intervention

We will translate and adapt an intervention developed by Ferreira et al. to address health literacy and improve CRC screening. This intervention combined a 2-hour health literacy training targeting primary care physicians (which also included information about CRC screening) and a patient level intervention that consisted of a brochure and video. In order to promote generalizability, large-scale diffusion, dissemination and sustained use beyond the funded-research period, we will use blended learning to develop a 2-hour e-learning health literacy training in French and a one-hour booster session. The patient-facing intervention (video + brochure) will follow key plain language and health literacy principles to translate evidence-based information in content that all patients can understand. Existing materials developed in France will be used and adapted as relevant.

Sponsors & Collaborators

  • National Cancer Institute, France

    collaborator OTHER_GOV
  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV
  • Centre Régional de Coordination des Dépistages des Cancers en Occitanie CRCDC-OC

    collaborator UNKNOWN
  • Aix Marseille Université

    collaborator OTHER
  • Assistance Publique Hopitaux De Marseille

    collaborator OTHER
  • Centre Régional de Coordination des Dépistages des Cancers Sud PACA

    collaborator UNKNOWN
  • Laboratoire HESPER-EA 7425

    collaborator UNKNOWN
  • INSERM, UMR-S 1123 ECEVE Université de Paris

    collaborator UNKNOWN
  • Centre Régional de Coordination du dépistage des cancers - Ile-de-France

    collaborator UNKNOWN
  • University Paris 7 - Denis Diderot

    collaborator OTHER
  • Centre Régional de Coordination du dépistage des cancers - Auvergne-Rhône-Alpes

    collaborator UNKNOWN
  • Institut Paoli-Calmettes

    collaborator OTHER
  • University Paul Sabatier of Toulouse

    lead OTHER

Principal Investigators

  • Marie-Anne Durand · Université Toulouse III Paul Sabatier

  • Niamh M REDMOND, PhD · Université Toulouse III Paul Sabatier

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-01
Primary Completion
2024-12-07
Completion
2025-04-14

Countries

  • France

Study Locations

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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 NCT04631692 on ClinicalTrials.gov