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Recruiting NCT06827366

NCT06827366 Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN)

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Clinical Trial Summary
NCT ID NCT06827366
Status Recruiting
Phase
Sponsor Centre Leon Berard
Condition Colorectal Cancer Screening
Study Type INTERVENTIONAL
Enrollment 800 participants
Start Date 2026-01-26
Primary Completion 2027-11-15

Trial Parameters

Condition Colorectal Cancer Screening
Sponsor Centre Leon Berard
Study Type INTERVENTIONAL
Phase N/A
Enrollment 800
Sex ALL
Min Age 35 Years
Max Age 74 Years
Start Date 2026-01-26
Completion 2027-11-15
Interventions
Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy

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Brief 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). 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.

Eligibility 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 un

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