NCT05273931Completed

Lifestyle Intervention After Colonoscopy (LIFE-SCREEN Pilot)

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

Source: ClinicalTrials.gov · Last updated 12 Feb 2024

Brief summary (registry, in English)

The study aims to evaluate the impact of promoting advice on the latest evidence-based diet and lifestyle recommendations for cancer prevention at colorectal cancer (CRC) screening among individuals who may be at higher risk for developing CRC. The overall aim of this LIFE-SCREEN pilot study is to test the trial methods and procedures to be used in the LIFE-SCREEN cluster randomized RCT, in order to discover obstacles and problems prior to the main RCT so that corrective actions can be taken to improve the research process. The patients (n=40) will be recruited at the Centre Léon Bérard and at the Hôpital Edouard Herriot at the time of CRC screening. After inclusion, the intervention material (documents explaining the strategies to achieve and maintain recommended behaviours as part of a healthier lifestyle) may be given to the patient during the pre-colonoscopy consultation and/or at the post-colonoscopy visit. Weight, height and blood pressure will be measured during the pre-colonoscopy consultation. Patients will be invited to complete a baseline questionnaire to collect information on their lifestyle, state of health and socio-demographic status. Approximately four to six weeks after, patients will also be asked to complete an evaluation questionnaire asking for their opinion on this material and the procedures. Focus groups with available and willing participants and hospital staff will be organized at the end of the pilot phase recruitment, to gather additional information on the intervention procedures. In addition, all hospital staff will be asked to complete an assessment questionnaire. Biological samples will then also be collected to test the objective baseline measure of nutritional changes used in the RCT. In order to assess the feasibility and the acceptability of urine, faecal and blood sample collection in this population, the first ten participants recruited (n=10) will be given the option to refuse one or more of the biological sample collections (phase I). Participants will also be asked to complete a questionnaire to provide information on their opinion and willingness to donate biological samples. This assessment questionnaire will allow us to refine the strategies for the other 30 participants (phase II). In this phase II, biological samples will be compulsory (phase IIa) or optional (phase IIb) for all 30 participants.

Status (registry): Completed
Study type: Interventional
Enrollment: 24 (actual)
First submitted: 1 Mar 2022
Start date: 16 Mar 2022
Primary completion date: 31 Dec 2023
Lead sponsor: Centre Leon Berard
Diseases: Colorectal cancer
NCT number: NCT05273931

What you commit to

Study type: Interventional
Participants enrolled: 24
From 16 Mar 2022 to the primary completion date, 31 Dec 2023
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Planned extensive intestinal surgery such as colectomy or surgical resection of the colon
Use of probiotic medications in the past 3 months
Concomitant participation in another study on lifestyle

Other illness

On a strict diet such as meal replacements, diets for co-morbidities such as diabetes
Lacking mobility due to physical constraints (e.g. handicap that is not compatible with physical activities, uncontrolled cardiovascular diseases/hypertension)
Chronic gastrointestinal illness (IBD, IBS, celiac disease)
History or existence of a primary cancer (apart from an in-situ cancer whatever the location and / or of a cutaneous basal cell cancer and / or of a CRC in complete remission for more than 5 years)

Other

Use of any systemic antibiotics, antifungals, antivirals, or antiparasitics in the past 3 months
In a state of severe malnutrition, either:
- ≥10% weight loss in 1 month or ≥ 15% in 6 months
Cannot be followed for medical, social, family, geographic or psychological reasons, throughout the duration of the study
Deprived of liberty by court or administrative decision
Pregnant (for women)
Optimal lifestyle habits (WCRF score \>6) will also be excluded from the pilot study as this participants are not part of target population that could benefit significantly from lifestyle advice (short screener will be completed by patients while in waiting room for pre-colonoscopy visit).
- Patients who will be positive for CRC (histological confirmation after colonoscopy) will end prematurely the study.

Who the study is looking for

35-74 years of age
At increased risk for developing colorectal cancer (CRC), defined here as having a positive faecal immunochemical test (FIT), or family history or symptoms for CRC and identified adenomas but CRC negative during the colonoscopy
Volunteer and available to get involved in the project throughout the duration of the study,
Be able to provide informed consent
Having health insurance (Affiliated to the French social security)
Score on the adherence to the WCRF recommendations lower or equal to 6 out of 9 (the WCRF score will be assessed based on a short lifestyle questionnaire, annex 1)
Able to read, write and understand French language

Age in the registry: 35 years to 74 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Centre Leon Berard Coordinator of this site? Confirm its status	Lyon	France	Unknown status
Hôpital Edouard Herriot, HCL Coordinator of this site? Confirm its status	Lyon	France	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.