Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program

NCT04257526 | Unknown DMC

• 1 other identifier: PP201907-26
• Study Type: interventional
• Target: 500
• 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 biological pathways linked to colorectal cancer development including physical fitness, anthropometrics, biomarkers for nutrition, and metabolic health.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; prevention

Outcome Measures

Primary Outcomes (2)

• Change in knowledge score assessed via a knowledge questionnaire

  The knowledge regarding the effect of lifestyle factors on cancer risk and cancer prevention lifestyle recommendations will be assessed via a knowledge score derived from the General Nutrition \& Physical Activity Knowledge Questionnaires

  1 year

• Improvement in lifestyle score assessed via lifestyle questionnaires

  WCRF lifestyle score will be assessed through lifestyle questionnaires. Compliance with the WCRF recommendations is considered achieved if this WCRF lifestyle score increases to more than 5 out of 8. The following questionnaires will be used to assess lifestyle changes: French EPIC food frequency questionnaire; the International Physical Activity Questionnaires - IPAQ; Weight and height measurements to assess BMI.

  1 year

Study Arms (2)

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.

Control

NO INTERVENTION

Colorectal cancer free participants receive the 'usual care' 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: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At high risk for CRC but CRC negative (confirmed by colonoscopy)
• Able to provide informed consent
• Understanding and able to speak French

You may not qualify if:

• Extensive intestinal surgery such as colectomy or surgical resection of the colon
• Chronic gastrointestinal illness (inflammatory bowel disease (IBD), irritable bowel syndrome (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
• 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)

Sponsors & Collaborators

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

Study Sites (1)

International Agency for Research on Cancer

Lyon, Rhone, 69008, France

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Marc J Gunter, PhD

  International Agency for Research on Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc J Gunter, PhD

CONTACT

0033472738093; GunterM@iarc.fr

Inge Huybrechts, PhD

CONTACT

0033472738148; HuybrechtsI@iarc.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2019
• First Posted: February 6, 2020
• Study Start: March 23, 2022
• Primary Completion: May 31, 2024
• Study Completion: December 31, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)