Actively Recruiting

Phase Not Applicable
Age: 35Years - 74Years
All Genders
ID06827366

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

Led by Centre Leon Berard · Updated on 2026-05-05

800

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

C

Centre Leon Berard

Lead Sponsor

I

International Agency for Research on Cancer

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how giving advice on diet and lifestyle during colorectal cancer screening affects people at higher risk for colorectal cancer. This study focuses on individuals who have tested positive on a faecal immunochemical test (FIT), have adenomas, but do not have colorectal cancer. The goal is to develop and assess a lifestyle intervention based on recommendations from the World Cancer Research Fund and the French National Cancer Institute, aiming to improve adherence to healthy habits and quality of life. The study is a randomized controlled trial with two groups: one receiving usual care after screening and colonoscopy, and the other receiving usual care plus evidence-based diet and lifestyle advice. This advice will be delivered by health professionals through various materials like leaflets and digital information. The intervention and baseline measurements occur two to three weeks after colonoscopy. Data will be collected at baseline, 3, 6, and 12 months to measure changes in diet, lifestyle, quality of life, and body measurements. Participants will complete questionnaires about their lifestyle, health, and medical history at several time points. Anthropometric measurements will be taken at baseline and follow-up visits. The main outcome measured is how well participants stick to the recommended lifestyle changes after 3 months. The study will use both statistical and qualitative methods to analyze the results, which could provide valuable information for cancer prevention programs.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 35Years - 74Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have read the information note and agree to participate
  • Willing and available to commit for a full year
  • At high risk for colorectal cancer but confirmed negative for colorectal cancer
  • Affiliated to a health security system
  • Have a baseline adherence score to recommendations of 7 or less out of 9
  • Able to read, write, and understand French
Not Eligible

You will not qualify if you...

  • Following a strict diet such as meal replacements or diets for co-morbidities like diabetes
  • Immobile due to physical constraints incompatible with physical activity
  • Have had extensive intestinal surgery such as colectomy or colon resection
  • Have chronic gastrointestinal illnesses like inflammatory bowel disease, irritable bowel syndrome, or celiac disease
  • Have confirmed colorectal cancer or history of a primary cancer
  • Suffering from severe malnutrition
  • Pregnant
  • Currently participating in another lifestyle study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) during colorectal cancer screening and colonoscopy

Outpatient Treatment

Duration - 12 months

Participants receive evidence-based diet and lifestyle advice or usual care following a positive faecal immunochemical test and diagnostic colonoscopy.

Baseline visit and follow-up visits at 3, 6, and 12 months

Trial Site Locations

Total: 1 location

1

Centre Léon Bérard

Lyon, France, France, 69008

Actively Recruiting

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Research Team

I

Inge Huybretchts, PhD

G

Genevieve Nicolas, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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