Lifestyle advice for people with adenomas after a positive colorectal screening test

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm randomized controlled trial comparing an evidence-based diet and lifestyle advice program with usual care for individuals at higher colorectal cancer risk identified through screening. Participants are recruited after a positive fecal immunochemical test (FIT) and colonoscopy showing adenomas but no cancer, and the intervention is delivered by health professionals using leaflets, posters and digital materials based on WCRF and French INCA recommendations and habit-formation theory. Primary outcomes include adherence to target diet and lifestyle recommendations, subjective health measures including quality of life, and anthropometric changes; biospecimen collection was removed after a 2022–2024 pilot for feasibility reasons. Enrollment and follow-up last one year, with random allocation to intervention or usual care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

NB : For this study, there is no exclusion period from other research, and participants can simultaneously take part in another study unless it concerns lifestyle.

Where it's running

• Centre Léon Bérard
  Lyon, France, France Recruiting

Study contacts

• Study coordinator: Inge Huybretchts, PhD
• Email: huybrechtsi@iarc.who.int
• Phone: +33695925958

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Total underwater colonoscopy for better colorectal cancer screening

  This study is testing if total underwater colonoscopy can find more hard-to-detect lesions during colorectal cancer screening in people who need a colonoscopy after a positive stool test.

  Recruiting at 5 sites Vestre Viken Hospital Trust · Drammen and 4 other locations · NCT06333392

• Knife-assisted full-thickness resection for rectal lesions in a multicenter setting

  A multicenter study tests knife-assisted full-thickness resection (kFTR) to remove rectal lesions in adults and see how well it works and how safe it is.

  Recruiting University Hospital, Ghent · Ghent · NCT07923682

• Personalized 3D Bioprinted Colorectal Cancer Microenvironment Model

  This study tests patient-derived, 3D-bioprinted cancer models that include tumor, fibroblast, and immune cells to see if they can better predict how colorectal cancer will respond to treatment.

  Recruiting Peking Union Medical College Hospital · Ningbo, Zhejiang · NCT07919418

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Prehabilitation with Resistance, Aerobic, or Both Before Colorectal Surgery

  Four pre-surgery exercise options (resistance, aerobic, both, or none) will be tested to see which best reduces complications after colorectal cancer surgery.

  Recruiting Semmelweis University · Budapest · NCT07896174

• Liver transplantation for colorectal cancer with liver metastases

  This study follows adults with stage IV colorectal cancer whose disease is limited to the liver and who are getting a liver transplant as part of their cancer care to see how they fare over time.

  Recruiting Pontificia Universidad Catolica de Chile · Santiago, Santiago Metropolitan · NCT07884110

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.