Colorectal Cancer ScreeningLIFE-SCREENNCT06827366
Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN)
A study testing Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy in people with Colorectal Cancer Screening and Colorectal Cancer Prevention, run by Centre Leon Berard at 1 site in France.
Trial summary
The investigators propose a randomized controlled trial to develop and evaluate the impact of promoting advice on diet and lifestyle recommendations for cancer prevention at colorectal cancer screening among individuals who may be at higher risk for colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 35 to 74 years
- Conditions the study is for
- Colorectal Cancer Screening, Colorectal Cancer Prevention, Colorectal Cancer
- What is being tested?
- Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2026to 15 Feb 2028
- 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 35 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having read the information note and agreeing to participate
- Will and availability to be committed for a full year
- At high risk for CRC but CRC negative
- Affiliated to a health security system
- Having a score on the adherence to the recommendation lower than or equal to 7 out of 9 at baseline.
- Able to read, write and understand French
Who cannot join
- Under a strict diet such as meal replacements, diets for co-morbidities such as diabetes
- Immobile due to physical constraints (e.g. handicap that is not compatible with physical activities)
- Extensive intestinal surgery such as colectomy or surgical resection of the colon
- Chronic gastrointestinal illness (IBD, IBS, celiac disease)
- Colorectal cancer confirmed or history of a primary cancer
- Severe malnutrition
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- Pregnant
- Participation in another lifestyle study
- NB : For this study, there is no exclusion period from other research, and participants can simultaneously take part in another study unless it concerns lifestyle.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Genevieve Nicolas, MSc contact
France1 site, 1 recruiting
- Recruiting
Centre Léon Bérard
Lyon, France, 69008
Aurélia Maire, MSc, +33469856362, aurelia.maire@lyon.unicancer.fr
Olivia Pérol, PhD, +33478782897, olivia.perol@lyon.unicancer.fr
About this study
The investigators propose a randomized controlled trial to develop and evaluate the impact of promoting advice on diet and lifestyle recommendations for cancer prevention at colorectal cancer screening among individuals who may be at higher risk for colorectal cancer (CRC). The specific objectives of this study are to 1) develop a lifestyle intervention based on evidenced-based diet and lifestyle recommendations (i.e. those proposed by the World Cancer Research Fund (WCRF) and the French National Cancer Institute); 2) evaluate the effect of the intervention on the adherence to the target diet and lifestyle recommendations as well as other subjective health measures, including quality of life; 3) evaluate the effect of the intervention on anthropometrics.
Read the detailed description
A pilot study was launched on March 23rd 2022 to assess the feasibility and acceptance of the LIFE-SCREEN study protocol. During the pilot study, participants were asked to complete several questionnaires about their lifestyle and health, while also having their anthropometrics measured and optional their blood taken and faecal sample collected. Evaluation questionnaires were completed by all participants and some participated in focus group meetings. Based upon this pilot study, it was decided in 2024 to drop the biospecimen collections due to feasibility issues.
This RCT study launched in November 2024 will be a parallel, two-arm, randomized controlled trial (RCT) in individuals at higher risk of colorectal cancer (CRC), comparing an evidence-based diet and lifestyle advice intervention with 'usual care'. Participants will be recruited during CRC screening and will be included if they have a positive faecal immunochemical test (FIT) and are diagnosed with adenomas but are CRC negative during the colonoscopy. The advice provided will be developed based on the World Cancer Research Fund (WCRF) \& French National Cancer Institute (INCA) evidence-based diet and lifestyle recommendations using the habit-theory and will be delivered using multiple materials (e.g. leaflets, posters and digital information) by health professionals in hospitals based in the Rhone region, France. Invitation to participate in the trial will be performed by the gastroenterologist during the clinical visit to provide information on colonoscopy, but the delivery of the intervention and baseline measurement will happen two to three weeks after the colonoscopy. Data will be collected at baseline, 3, 6 and 12 months. At baseline, participants will be required to answer questionnaires on sociodemographic and medical history. At all aforementioned time points, online or paper-based questionnaires will be administered to collect information on diet and lifestyle behaviours, knowledge on healthy lifestyle, quality of life and medical therapy. Participants will also have their anthropometric measured during baseline and follow-up appointments. The primary outcome of this intervention will be adherence to target recommendations at 3 months and beyond. Univariate and multivariate statistical analyses as well as qualitative analyses will be performed.
Providing lifestyle advice for cancer prevention at screening programs is a new field in public health that has the potential to be cost-effective, convenient, appealing and widereaching. It may also help to reach individuals at higher risk at a time-window when they adherence to cancer prevention recommendations, as well as on quality of life and body weight among individuals at higher risk of CRC.
- Being tested
- Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy
- Keywords
- colorectal cancer, primary prevention, screening, physical activity, nutrition, recommendations
- Medical subject headings
- Colorectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopyBehavioural
Participants will be recruited during CRC screening and will be included if they have a positive faecal immunochemical test (FIT) and are diagnosed with adenomas but are CRC negative during the colonoscopy. Participants receive evidence-based diet and lifestyle advice intervention with 'usual care'
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Colorectal cancer free participants receive the 'usual care' following a positive FIT test and diagnostic colonoscopy |
| Intervention | Active comparator | Colorectal cancer free participants receive evidence-based diet and lifestyle advice in addition to the 'usual care' following a positive FIT test and diagnostic colonoscopy Receives: Behavioral: Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the evidence-based lifestyle recommendations
The primary outcome of the trial will be adherence to the evidence-based lifestyle recommendations (expressed as an adherence score on the individual lifestyle recommendations).
Score :
- unabbreviated scale title : World Cancer Research Fund's (WCRF)
- minimum value = 0 (more unhealthy behaviours) / maximum value = 7 (more healthy behaviours)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start26 Jan 2026
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- International Agency for Research on Cancer, University of Bordeaux, Hôpital Edouard Herriot
- Responsible party
- Sponsor
- Investigators
- Inge Huybretchts, PhD, Study director, International Agency Research Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827366
- Sponsor's protocol ID
- LIFE-SCREEN (ET 24-226)
- Acronym
- LIFE-SCREEN
- Status last verified
- Jan 2026
- First submitted
- 24 Oct 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN)
- ClinicalTrials.gov ID
- NCT06827366
- Acronym / sponsor ID
- LIFE-SCREEN / LIFE-SCREEN (ET 24-226)
- Keywords
- colorectal cancer, primary prevention, screening, physical activity, nutrition, recommendations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- International Agency for Research on Cancer, University of Bordeaux, Hôpital Edouard Herriot
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Feb 2028 (estimated)
- First posted
- 14 Feb 2025 (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 investigators propose a randomized controlled trial to develop and evaluate the impact of promoting advice on diet and lifestyle recommendations for cancer prevention at colorectal cancer screening among individuals who may be at higher risk for colorectal cancer (CRC). The specific objectives of this study are to 1) develop a lifestyle intervention based on evidenced-based diet and lifestyle recommendations (i.e. those proposed by the World Cancer Research Fund (WCRF) and the French National Cancer Institute); 2) evaluate the effect of the intervention on the adherence to the target diet and lifestyle recommendations as well as other subjective health measures, including quality of life; 3) evaluate the effect of the intervention on anthropometrics.
Detailed description
A pilot study was launched on March 23rd 2022 to assess the feasibility and acceptance of the LIFE-SCREEN study protocol. During the pilot study, participants were asked to complete several questionnaires about their lifestyle and health, while also having their anthropometrics measured and optional their blood taken and faecal sample collected. Evaluation questionnaires were completed by all participants and some participated in focus group meetings. Based upon this pilot study, it was decided in 2024 to drop the biospecimen collections due to feasibility issues.
This RCT study launched in November 2024 will be a parallel, two-arm, randomized controlled trial (RCT) in individuals at higher risk of colorectal cancer (CRC), comparing an evidence-based diet and lifestyle advice intervention with 'usual care'. Participants will be recruited during CRC screening and will be included if they have a positive faecal immunochemical test (FIT) and are diagnosed with adenomas but are CRC negative during the colonoscopy. The advice provided will be developed based on the World Cancer Research Fund (WCRF) \& French National Cancer Institute (INCA) evidence-based diet and lifestyle recommendations using the habit-theory and will be delivered using multiple materials (e.g. leaflets, posters and digital information) by health professionals in hospitals based in the Rhone region, France. Invitation to participate in the trial will be performed by the gastroenterologist during the clinical visit to provide information on colonoscopy, but the delivery of the intervention and baseline measurement will happen two to three weeks after the colonoscopy. Data will be collected at baseline, 3, 6 and 12 months. At baseline, participants will be required to answer questionnaires on sociodemographic and medical history. At all aforementioned time points, online or paper-based questionnaires will be administered to collect information on diet and lifestyle behaviours, knowledge on healthy lifestyle, quality of life and medical therapy. Participants will also have their anthropometric measured during baseline and follow-up appointments. The primary outcome of this intervention will be adherence to target recommendations at 3 months and beyond. Univariate and multivariate statistical analyses as well as qualitative analyses will be performed.
Providing lifestyle advice for cancer prevention at screening programs is a new field in public health that has the potential to be cost-effective, convenient, appealing and widereaching. It may also help to reach individuals at higher risk at a time-window when they adherence to cancer prevention recommendations, as well as on quality of life and body weight among individuals at higher risk of CRC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Colorectal cancer free participants receive the 'usual care' following a positive FIT test and diagnostic colonoscopy |
| Intervention | Active comparator | Behavioral: Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopyColorectal cancer free participants receive evidence-based diet and lifestyle advice in addition to the 'usual care' following a positive FIT test and diagnostic colonoscopy |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having read the information note and agreeing to participate
- Will and availability to be committed for a full year
- At high risk for CRC but CRC negative
- Affiliated to a health security system
- Having a score on the adherence to the recommendation lower than or equal to 7 out of 9 at baseline.
Key exclusion criteria (9 listed)
- Under a strict diet such as meal replacements, diets for co-morbidities such as diabetes
- Immobile due to physical constraints (e.g. handicap that is not compatible with physical activities)
- Extensive intestinal surgery such as colectomy or surgical resection of the colon
- Chronic gastrointestinal illness (IBD, IBS, celiac disease)
- Colorectal cancer confirmed or history of a primary cancer
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 |
|---|---|---|
| Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopyParticipants will be recruited during CRC screening and will be included if they have a positive faecal immunochemical test (FIT) and are diagnosed with adenomas but are CRC negative during the colonoscopy. Participants receive evidence-based diet and lifestyle advice intervention with 'usual care' | Behavioural | Intervention |
Primary outcome
Adherence to the evidence-based lifestyle recommendations
Time frame: 3 months
The primary outcome of the trial will be adherence to the evidence-based lifestyle recommendations (expressed as an adherence score on the individual lifestyle recommendations). Score : * unabbreviated scale title : World Cancer Research Fund's (WCRF) * minimum value = 0 (more unhealthy behaviours) / maximum value = 7 (more healthy behaviours)
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 5 May 2026.
- 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.
Genevieve Nicolas, MSc contact
Inge Huybretchts, PhD study director
International Agency Research Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy in people with Colorectal Cancer Screening and Colorectal Cancer Prevention, run by Centre Leon Berard at 1 site 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Inge Huybretchts, PhD (+33695925958, huybrechtsi@iarc.who.int), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the evidence-based lifestyle recommendations (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.