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

NCT04631692 | Active Not Recruiting

• 1 other identifier: 2020-A01687-32
• Study Type: interventional
• Target: 1,025
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer screening uptake

  This information will be collected by each regional screening coordination center of the four participating regions, in collaboration with the health insurance (CPAM) at 6 months (for feedback to general practitioners in the intervention arm) and 1-year post enrollment into the study. It will also be collected using self-report in the patient questionnaire 1-year post enrollment.

  up to 1-year post enrollment

Study Arms (2)

Usual care

NO INTERVENTION

Usual care in participating primary care practices.

Health literacy intervention

ACTIVE COMPARATOR

Health literacy intervention combining health literacy and colorectal cancer screening training for general practitioners with a short brochure and video targeting eligible patients.

Behavioral: Health literacy intervention

Interventions

Health literacy intervention BEHAVIORAL

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.

Health literacy intervention

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People between 50 and 74 years old who are eligible for colorectal cancer screening and seen by a participating general practitioner.
• People who are able to complete a questionnaire in French, either alone or with help from a caregiver or relative.
• People with intellectual disability will be included as long as they are able to complete a questionnaire alone or with help from a caregiver or relative.

You may not qualify if:

• \- People whose mental health status does preclude participation in the study, as determined by the participating primary care practitioner or their qualified staff.

Sponsors & Collaborators

• University Paul Sabatier of Toulouse: lead
• National Cancer Institute, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Centre Régional de Coordination des Dépistages des Cancers en Occitanie CRCDC-OC: collaborator
• Aix Marseille Université: collaborator
• Assistance Publique Hopitaux De Marseille: collaborator
• Centre Régional de Coordination des Dépistages des Cancers Sud PACA: collaborator
• Laboratoire HESPER-EA 7425: collaborator
• INSERM, UMR-S 1123 ECEVE Université de Paris: collaborator
• Centre Régional de Coordination du dépistage des cancers - Ile-de-France: collaborator
• University Paris 7 - Denis Diderot: collaborator
• Centre Régional de Coordination du dépistage des cancers - Auvergne-Rhône-Alpes: collaborator
• Institut Paoli-Calmettes: collaborator

Study Sites (4)

Service de recherche et épidémiologie cliniques

Lyon, France

Location

Espace santé APHM

Marseille, France

Location

Assistance Publique Hopitaux de Paris

Paris, France

Location

Faculté de médecine

Toulouse, France

Location

Related Publications (1)

• Durand MA, Lamouroux A, Redmond NM, Rotily M, Bourmaud A, Schott AM, Auger-Aubin I, Frachon A, Exbrayat C, Balamou C, Gimenez L, Grosclaude P, Moumjid N, Haesebaert J, Massy HD, Bardes J, Touzani R, Diant LBEF, Casanova C, Seitz JF, Mancini J, Delpierre C. Impact of a health literacy intervention combining general practitioner training and a consumer facing intervention to improve colorectal cancer screening in underserved areas: protocol for a multicentric cluster randomized controlled trial. BMC Public Health. 2021 Sep 16;21(1):1684. doi: 10.1186/s12889-021-11565-3.

  PMID: 34530800 DERIVED

Study Officials

• Marie-Anne Durand

  Université Toulouse III Paul Sabatier

  PRINCIPAL INVESTIGATOR

• Niamh M REDMOND, PhD

  Université Toulouse III Paul Sabatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking investigator, research assistants and data analyst
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: We will use a two-arm randomized controlled cluster trial design trial with 8 clusters in total (2 clusters per region) and 4 general practitioners per cluster (i.e. 32 doctors in total). We will target disadvantaged areas in the following regions: Marseille, Lyon, Toulouse and Paris. We will use two ecological indexes of disadvantage: the European Deprivation Index (EDI) and the French Deprivation Index (FDEP). A community-based participatory research approach will be privileged throughout this project as well as focus groups and interviews

Study Record Dates

• First Submitted: November 10, 2020
• First Posted: November 17, 2020
• Study Start: October 1, 2021
• Primary Completion: December 7, 2024
• Study Completion: April 14, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)