Colorectal CancerNCT05273931
Lifestyle Intervention After Colonoscopy (LIFE-SCREEN Pilot)
A study testing Lifestyle intervention in people with Colorectal Cancer, run by Centre Leon Berard at 2 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Lifestyle intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Mar 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- Planned extensive intestinal surgery such as colectomy or surgical resection of the colon
- Chronic gastrointestinal illness (IBD, 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
Show all 15Show fewer
- 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)
- 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)
- Concomitant participation in another study on lifestyle
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN Pilot)
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.
Read more
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.
- Conditions
- Colorectal Cancer
- Being tested
- Lifestyle intervention
- Keywords
- Colorectal cancer, Higher risk, Lifestyle intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle interventionOther
Documents explaining the strategies to achieve and maintain recommended behaviours as part of a healthier lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Lifestyle intervention among participants of the French colorectal cancer screening program Receives: Other: Lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in adherence to the lifestyle recommendations between baseline and the 4 week follow-up
Adherence to the lifestyle recommendations will be measured by the WCRF questionnaire (Diet and Physical Activity)
Measured: Change between Baseline and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start16 Mar 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne CATTEY-JAVOUHEY, MD, PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273931
- Sponsor's protocol ID
- LIFE-SCREEN pilot
- Status last verified
- Feb 2024
- First submitted
- 1 Mar 2022
- Last updated
- 12 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program (LIFE-SCREEN Pilot)
- ClinicalTrials.gov ID
- NCT05273931
- Acronym / sponsor ID
- LIFE-SCREEN pilot
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Higher risk, Lifestyle intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Other: Lifestyle interventionLifestyle intervention among participants of the French colorectal cancer screening program |
Who may qualify
- Ages
- 35 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (15 listed)
- 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)
- Planned extensive intestinal surgery such as colectomy or surgical resection of the colon
- Chronic gastrointestinal illness (IBD, IBS, celiac disease)
- Use of any systemic antibiotics, antifungals, antivirals, or antiparasitics in the past 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle interventionDocuments explaining the strategies to achieve and maintain recommended behaviours as part of a healthier lifestyle | Other | Lifestyle intervention |
Primary outcome
Changes in adherence to the lifestyle recommendations between baseline and the 4 week follow-up
Time frame: Change between Baseline and Week 4
Adherence to the lifestyle recommendations will be measured by the WCRF questionnaire (Diet and Physical Activity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne CATTEY-JAVOUHEY, MD, PhD principal investigator
Centre Leon Berard
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle intervention in people with Colorectal Cancer, run by Centre Leon Berard at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in adherence to the lifestyle recommendations between baseline and the 4 week follow-up (time frame: Change between Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024; AzTrials last refreshed its copy on 2 Nov 2026.