Colorectal Cancer ScreeningDECODENCT04631692
Evaluating a Health Literacy Intervention to Improve Colorectal Cancer Screening in Underserved Areas
A study testing Health literacy intervention in people with Colorectal Cancer Screening, run by University Paul Sabatier of Toulouse at 4 sites in France.
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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Health literacy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,025 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2021to 14 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- People whose mental health status does preclude participation in the study, as determined by the participating primary care practitioner or their qualified staff.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Service de recherche et épidémiologie cliniques
Lyon
Espace santé APHM
Marseille
Assistance Publique Hopitaux de Paris
Paris
Faculté de médecine
Toulouse
About this study
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
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.
Read the 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).
- Conditions
- Colorectal Cancer Screening
- Being tested
- Health literacy intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health literacy interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Health literacy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 1-year post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Oct 2021
- Primary completion7 Dec 2024
- Study completion14 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,025 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paul Sabatier of Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Institut National de la Santé Et de la Recherche Médicale, France, Aix Marseille Université, Assistance Publique Hopitaux De Marseille, Laboratoire HESPER-EA 7425, INSERM, UMR-S 1123 ECEVE Université de Paris, University Paris 7 - Denis Diderot, Institut Paoli-Calmettes
- Responsible party
- Principal investigator, Marie-Anne Durand, University Paul Sabatier of Toulouse
- Investigators
- Marie-Anne Durand, Principal investigator, Université Toulouse III Paul SabatierNiamh M REDMOND, PhD, Principal investigator, Université Toulouse III Paul Sabatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631692
- Sponsor's protocol ID
- 2020-A01687-32
- Acronym
- DECODE
- Status last verified
- Mar 2025
- First submitted
- 10 Nov 2020
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cazorla G, Redmond NM, Lamouroux A, Boirot A, Rotily M, Addamiano MC, Balamou C, Doukhi Z, Kaou M, Couranjou F, Delpierre C, Mancini J, Durand MA. Acceptability and implementation potential of colorectal cancer screening and health literacy training: A qualitative study among general practitioners in deprived areas. PLoS One. 2025 Feb 11;20(2):e0317910. doi: 10.1371/journal.pone.0317910. eCollection 2025.
PubMed 39932910Durand 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.
PubMed 34530800
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04631692
- Acronym / sponsor ID
- DECODE / 2020-A01687-32
- Conditions
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,025 participants (actual)
- Lead sponsor
- University Paul Sabatier of ToulouseUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Institut National de la Santé Et de la Recherche Médicale, France, Aix Marseille Université, Assistance Publique Hopitaux De Marseille, Laboratoire HESPER-EA 7425, INSERM, UMR-S 1123 ECEVE Université de Paris, University Paris 7 - Denis Diderot, Institut Paoli-Calmettes
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 7 Dec 2024 (actual)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Usual care in participating primary care practices. |
| Health literacy intervention | Active comparator | Behavioral: Health literacy interventionHealth literacy intervention combining health literacy and colorectal cancer screening training for general practitioners with a short brochure and video targeting eligible patients. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- People whose mental health status does preclude participation in the study, as determined by the participating primary care practitioner or their qualified staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health literacy interventionWe 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. | Behavioural | Health literacy intervention |
Primary outcome
Colorectal cancer screening uptake
Time frame: up to 1-year post enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Derived from this study: PubMed 39932910Cazorla G, Redmond NM, Lamouroux A, Boirot A, Rotily M, Addamiano MC, Balamou C, Doukhi Z, Kaou M, Couranjou F, Delpierre C, Mancini J, Durand MA. Acceptability and implementation potential of colorectal cancer screening and health literacy training: A qualitative study among general practitioners in deprived areas. PLoS One. 2025 Feb 11;20(2):e0317910. doi: 10.1371/journal.pone.0317910. eCollection 2025.
- Derived from this study: PubMed 34530800Durand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Anne Durand principal investigator
Université Toulouse III Paul Sabatier
Niamh M REDMOND, PhD principal investigator
Université Toulouse III Paul Sabatier
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health literacy intervention in people with Colorectal Cancer Screening, run by University Paul Sabatier of Toulouse at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer screening uptake (time frame: up to 1-year post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631692, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.