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

Colorectal Cancer Screening Clinical Trial

— DECODE  

Official title:

Impact of Health Literacy Training for General Practitioners and a Consumer Facing Intervention to Improve Colorectal Cancer Screening in Underserved Areas: A Multicentric Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04631692
• Other study ID #: 2020-A01687-32
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: University Paul Sabatier of Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background Colorectal cancer (CRC) is a leading cause of cancer burden worldwide and the third most commonly diagnosed cancer in France (with 44,000 new cases in France each year). Systematic uptake of CRC screening can improve survival rates. However, people with limited health literacy (HL) and lower socioeconomic position rarely participate. The overall goal is to assess the impact of a 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.

Methods 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. Primary care physicians practicing in underserved areas (identified using the European Deprivation Index and French Deprivation index) will be block-randomized to: 1) a combined intervention (HL and colorectal cancer training + brochure and video for eligible patients) or 2) usual care. The investigators will include all people between 50 and 74 years old who are eligible for CRC screening. The project will follow a community-based participatory research approach. The primary outcome is CRC screening uptake. The project will also include a qualitative needs assessment (focus groups and interviews) prior to finalizing the intervention and to test the acceptability of the combined intervention before the trial. After completing recruitment, semi-structured interviews will be conducted with up to 8 health professionals in each region (up to 24) and 6 to 12 patients per region (up to 48) based on data saturation. The investigators will explore strategies that promote the intervention's sustained use and rapid implementation using the Normalization Process Theory. A regression framework and mediation analyses will be used.

Discussion Limited HL and its impact on the general population is a growing public health and policy challenge worldwide. It has received limited attention in France. A combined HL intervention could reduce disparities in CRC screening, increase screening rates among most vulnerable populations, and increase knowledge and activation (beneficial in the context of repeat screening).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1025
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Service de recherche et épidémiologie cliniques	Lyon
France	Espace santé APHM	Marseille
France	Assistance Publique Hopitaux de Paris	Paris
France	Faculté de médecine	Toulouse

Sponsors (13)

Lead Sponsor

Collaborator

University Paul Sabatier of Toulouse

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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