Status:
COMPLETED
Lifestyle Intervention After Colonoscopy (LIFE-SCREEN Pilot)
Lead Sponsor:
Centre Leon Berard
Conditions:
Colorectal Cancer
Eligibility:
All Genders
35-74 years
Phase:
NA
Brief Summary
The study aims to evaluate the impact of promoting advice on the latest evidence-based diet and lifestyle recommendations for cancer prevention at colorectal cancer (CRC) screening among individuals w...
Eligibility Criteria
Inclusion
- 35-74 years of age
- At increased risk for developing colorectal cancer (CRC), defined here as having a positive faecal immunochemical test (FIT), or family history or symptoms for CRC and identified adenomas but CRC negative during the colonoscopy
- Volunteer and available to get involved in the project throughout the duration of the study,
- Be able to provide informed consent
- Having health insurance (Affiliated to the French social security)
- Score on the adherence to the WCRF recommendations lower or equal to 6 out of 9 (the WCRF score will be assessed based on a short lifestyle questionnaire, annex 1)
- Able to read, write and understand French language
Exclusion
- On a strict diet such as meal replacements, diets for co-morbidities such as diabetes
- Lacking mobility due to physical constraints (e.g. handicap that is not compatible with physical activities, uncontrolled cardiovascular diseases/hypertension)
- Planned extensive intestinal surgery such as colectomy or surgical resection of the colon
- Chronic gastrointestinal illness (IBD, IBS, celiac disease)
- Use of any systemic antibiotics, antifungals, antivirals, or antiparasitics in the past 3 months
- Use of probiotic medications in the past 3 months
- History or existence of a primary cancer (apart from an in-situ cancer whatever the location and / or of a cutaneous basal cell cancer and / or of a CRC in complete remission for more than 5 years)
- In a state of severe malnutrition, either:
- ≥10% weight loss in 1 month or ≥ 15% in 6 months
- Cannot be followed for medical, social, family, geographic or psychological reasons, throughout the duration of the study
- Deprived of liberty by court or administrative decision
- Pregnant (for women)
- Concomitant participation in another study on lifestyle
- Optimal lifestyle habits (WCRF score \>6) will also be excluded from the pilot study as this participants are not part of target population that could benefit significantly from lifestyle advice (short screener will be completed by patients while in waiting room for pre-colonoscopy visit).
- Patients who will be positive for CRC (histological confirmation after colonoscopy) will end prematurely the study.
Key Trial Info
Start Date :
March 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05273931
Start Date
March 16 2022
End Date
December 31 2023
Last Update
February 12 2024
Active Locations (2)
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1
Centre Léon Bérard
Lyon, France
2
Hôpital Edouard Herriot (HCL)
Lyon, France