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

NCT06827366 | Recruiting

• 1 other identifier: LIFE-SCREEN (ET 24-226)
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Screening; Colorectal Cancer Prevention; Colorectal Cancer

Keywords

colorectal cancer; primary prevention; screening; physical activity; nutrition; recommendations

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months

Study Arms (2)

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

Behavioral: Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy

Interventions

Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy BEHAVIORAL

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'

Intervention

Eligibility Criteria

• Age: 35 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Leon Berard: lead
• International Agency for Research on Cancer: collaborator
• University of Bordeaux: collaborator
• Hôpital Edouard Herriot: collaborator

Study Sites (1)

Centre Léon Bérard

Lyon, France, 69008, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Motor Activity

Interventions

Diet

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Inge Huybretchts, PhD

  International Agency Research Cancer

  STUDY DIRECTOR

Central Study Contacts

Inge Huybretchts, PhD

CONTACT

+33695925958; huybrechtsi@iarc.who.int

Genevieve Nicolas, MSc

CONTACT

nicolasg@iarc.who.int

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: February 14, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): February 15, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)