Lifestyle advice for people with adenomas after a positive colorectal screening test
Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN)
This trial will try giving evidence-based diet and lifestyle advice to people in France who had a positive FIT and adenomas but no cancer to see if it improves their diet, activity, quality of life, and body measurements over one year.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 35 Years to 74 Years |
| Sex | All |
| Sponsor | Centre Leon Berard Academic / other |
| Locations | 1 site (Lyon, France) |
| Trial ID | NCT06827366 on ClinicalTrials.gov |
What this trial studies
This is a two-arm randomized controlled trial comparing an evidence-based diet and lifestyle advice program with usual care for individuals at higher colorectal cancer risk identified through screening. Participants are recruited after a positive fecal immunochemical test (FIT) and colonoscopy showing adenomas but no cancer, and the intervention is delivered by health professionals using leaflets, posters and digital materials based on WCRF and French INCA recommendations and habit-formation theory. Primary outcomes include adherence to target diet and lifestyle recommendations, subjective health measures including quality of life, and anthropometric changes; biospecimen collection was removed after a 2022–2024 pilot for feasibility reasons. Enrollment and follow-up last one year, with random allocation to intervention or usual care.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults in the Rhône region who had a positive FIT, were found to have adenomas but no colorectal cancer at colonoscopy, can commit to one year of follow-up, and have baseline adherence ≤7/9 to the recommendations.
Not a fit: Patients on strict medical diets, with severe mobility limitations, with chronic inflammatory bowel disease or prior colorectal cancer, pregnant people, or those unable to follow the intervention materials are unlikely to benefit.
Why it matters
Potential benefit: If successful, participants may improve their diet and physical activity, reduce weight or waist size, and potentially lower future colorectal cancer risk.
How similar studies have performed: Previous lifestyle-advice interventions have shown moderate success at improving diet and physical activity in prevention settings, but delivering structured advice at the point of colorectal screening is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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.
Where this trial is running
Lyon, France
- Centre Léon Bérard — Lyon, France, France (Recruiting)
Study contacts
- Study coordinator: Inge Huybretchts, PhD
- Email: huybrechtsi@iarc.who.int
- Phone: +33695925958
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.