Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-74
SponsorCentre Leon Berard
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy
BehavioralParticipants 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'
Treatment groups
800 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: InterventionActive comparator 1 intervention
Trial outcomes
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)
Time frame
3 monthsSponsors and contacts
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Centre Leon Berard
Lead sponsor
International Agency for Research on Cancer
Collaborator
University of Bordeaux
Collaborator
Hôpital Edouard Herriot
Collaborator
Source ClinicalTrials.gov