Clinical trial NCT04631692: Evaluating a Health Literacy Intervention to Improve Colorectal Cancer Screening in Underserved Areas
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Cancer Screening
Lead sponsor: University Paul Sabatier of Toulouse
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Centre Régional de Coordination des Dépistages des Cancers en Occitanie CRCDC-OC
name: Aix Marseille Université
name: Assistance Publique Hopitaux De Marseille
name: Centre Régional de Coordination des Dépistages des Cancers Sud PACA
name: Laboratoire HESPER-EA 7425
name: INSERM, UMR-S 1123 ECEVE Université de Paris
name: Centre Régional de Coordination du dépistage des cancers - Ile-de-France
name: University Paris 7 - Denis Diderot
name: Centre Régional de Coordination du dépistage des cancers - Auvergne-Rhône-Alpes
name: Institut Paoli-Calmettes
First posted: 2020-11-17
Enrollment: 1025
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Colorectal cancer screening uptake
timeFrame: up to 1-year post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de recherche et épidémiologie cliniques
city: Marseille
country: France
facility: Espace santé APHM
city: Paris
country: France
facility: Assistance Publique Hopitaux de Paris
city: Toulouse
country: France
facility: Faculté de médecine
Study officials:
affiliation: Université Toulouse III Paul Sabatier
name: Marie-Anne Durand
role: PRINCIPAL_INVESTIGATOR
affiliation: Université Toulouse III Paul Sabatier
name: Niamh M REDMOND, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.