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Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program

NCT04257526 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-10-03

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

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'.

Sponsors & Collaborators

  • Centre Leon Berard

    collaborator OTHER

  • Hôpital Edouard Herriot

    collaborator OTHER

  • University of Bordeaux

    collaborator OTHER

  • International Agency for Research on Cancer

    lead OTHER

Principal Investigators

  • Marc J Gunter, PhD · International Agency for Research on Cancer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2024-05-31
Completion
2024-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04257526 on ClinicalTrials.gov