Colorectal CancerLIFE-SCREENNCT04257526
Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program
A study testing Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy. in people with Colorectal Cancer, run by International Agency for Research on Cancer at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2022to 31 Dec 2024
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At high risk for CRC but CRC negative (confirmed by colonoscopy)
- Able to provide informed consent
- Understanding and able to speak French
Who cannot join
- Extensive intestinal surgery such as colectomy or surgical resection of the colon
- Chronic gastrointestinal illness (inflammatory bowel disease (IBD), irritable bowel syndrome (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
- 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)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
International Agency for Research on Cancer
Lyon, Rhone, 69008
Marc J Gunter, PhD, 0033472738093, GunterM@iarc.fr
Inge Huybrechts, PhD, 0033472738148, HuybrechtsI@iarc.fr
About this study
Official title: Development and Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program
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.
Read the detailed description
This study will be a parallel, two-arm, randomized controlled trial (RCT) in individuals at higher risk of colorectal cancer (CRC), comparing an evidence-based diet and lifestyle advice intervention with 'usual care'. 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. The advice provided will be developed based on the World Cancer Research Fund (WCRF) \& French National Cancer Institute (INCA) evidence-based diet and lifestyle recommendations using the habit-theory and will be delivered using multiple materials (e.g. leaflets, posters and digital information) by health professionals in hospitals based in the Rhone region, France. Invitation to participate in the trial will be performed by the gastroenterologist during the clinical visit to provide information on colonoscopy, but the delivery of the intervention and baseline measurement will happen two to three weeks after the colonoscopy. Data will be collected at baseline, 3, 6 and 12 months. At baseline, participants will be required to answer questionnaires on sociodemographic and medical history. At all aforementioned time points, online or paper-based questionnaires will be administered to collect information on diet and lifestyle behaviours, knowledge on healthy lifestyle, quality of life and medical therapy. Participants will also have their anthropometric measures and physical fitness test taken and blood, faecal and colon tissue samples collected during baseline and follow-up appointments (tissue samples will be obtained only for those who are required to undergo the colonoscopy again at 12 months as part of the screening programme). The primary outcome of this intervention will be adherence to target recommendations at 3 months and beyond. Univariate and multivariate statistical analyses as well as qualitative analyses will be performed.
Providing lifestyle advice for cancer prevention at screening programs is a new field in public health that has the potential to be cost-effective, convenient, appealing and wide-reaching. It may also help to reach individuals at higher risk at a time-window when they are more receptive to advice on healthy lifestyles and more likely to make the required behavioural changes. The proposed intervention is expected to have a positive impact on adherence to cancer prevention recommendations, as well as on quality of life, biomarkers for cancer risk, physical fitness and body weight among individuals at higher risk of CRC.
- Conditions
- Colorectal Cancer
- Being tested
- Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy.
- Keywords
- colorectal cancer, prevention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy.Behavioural
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'.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Colorectal cancer free participants receive evidence-based diet and lifestyle advice in addition to the 'usual care' following a positive FIT test and diagnostic colonoscopy Receives: Behavioral: Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy. |
| Control | No intervention | Colorectal cancer free participants receive the 'usual care' following a positive FIT test and diagnostic colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knowledge score assessed via a knowledge questionnaire
The knowledge regarding the effect of lifestyle factors on cancer risk and cancer prevention lifestyle recommendations will be assessed via a knowledge score derived from the General Nutrition \& Physical Activity Knowledge Questionnaires
Measured: 1 year
Improvement in lifestyle score assessed via lifestyle questionnaires
WCRF lifestyle score will be assessed through lifestyle questionnaires. Compliance with the WCRF recommendations is considered achieved if this WCRF lifestyle score increases to more than 5 out of 8.
The following questionnaires will be used to assess lifestyle changes:
French EPIC food frequency questionnaire; the International Physical Activity Questionnaires - IPAQ; Weight and height measurements to assess BMI.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start23 Mar 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Leon Berard, Hôpital Edouard Herriot, University of Bordeaux
- Responsible party
- Sponsor
- Investigators
- Marc J Gunter, PhD, Principal investigator, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257526
- Sponsor's protocol ID
- PP201907-26
- Acronym
- LIFE-SCREEN
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2019
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Lifestyle Intervention Among Participants of the French Colorectal Cancer Screening Program
- ClinicalTrials.gov ID
- NCT04257526
- Acronym / sponsor ID
- LIFE-SCREEN / PP201907-26
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Centre Leon Berard, Hôpital Edouard Herriot, University of Bordeaux
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Feb 2020 (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 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.
Detailed description
This study will be a parallel, two-arm, randomized controlled trial (RCT) in individuals at higher risk of colorectal cancer (CRC), comparing an evidence-based diet and lifestyle advice intervention with 'usual care'. 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. The advice provided will be developed based on the World Cancer Research Fund (WCRF) \& French National Cancer Institute (INCA) evidence-based diet and lifestyle recommendations using the habit-theory and will be delivered using multiple materials (e.g. leaflets, posters and digital information) by health professionals in hospitals based in the Rhone region, France. Invitation to participate in the trial will be performed by the gastroenterologist during the clinical visit to provide information on colonoscopy, but the delivery of the intervention and baseline measurement will happen two to three weeks after the colonoscopy. Data will be collected at baseline, 3, 6 and 12 months. At baseline, participants will be required to answer questionnaires on sociodemographic and medical history. At all aforementioned time points, online or paper-based questionnaires will be administered to collect information on diet and lifestyle behaviours, knowledge on healthy lifestyle, quality of life and medical therapy. Participants will also have their anthropometric measures and physical fitness test taken and blood, faecal and colon tissue samples collected during baseline and follow-up appointments (tissue samples will be obtained only for those who are required to undergo the colonoscopy again at 12 months as part of the screening programme). The primary outcome of this intervention will be adherence to target recommendations at 3 months and beyond. Univariate and multivariate statistical analyses as well as qualitative analyses will be performed.
Providing lifestyle advice for cancer prevention at screening programs is a new field in public health that has the potential to be cost-effective, convenient, appealing and wide-reaching. It may also help to reach individuals at higher risk at a time-window when they are more receptive to advice on healthy lifestyles and more likely to make the required behavioural changes. The proposed intervention is expected to have a positive impact on adherence to cancer prevention recommendations, as well as on quality of life, biomarkers for cancer risk, physical fitness and body weight among individuals at higher risk of CRC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy.Colorectal cancer free participants receive evidence-based diet and lifestyle advice in addition to the 'usual care' following a positive FIT test and diagnostic colonoscopy |
| Control | No intervention | –Colorectal cancer free participants receive the 'usual care' following a positive FIT test and diagnostic colonoscopy |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At high risk for CRC but CRC negative (confirmed by colonoscopy)
- Able to provide informed consent
- Understanding and able to speak French
Key exclusion criteria (6 listed)
- Extensive intestinal surgery such as colectomy or surgical resection of the colon
- Chronic gastrointestinal illness (inflammatory bowel disease (IBD), irritable bowel syndrome (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
- Under a strict diet such as meal replacements, diets for co-morbidities such as diabetes
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 |
|---|---|---|
| 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'. | Behavioural | Intervention |
Primary outcome
Change in knowledge score assessed via a knowledge questionnaire
Time frame: 1 year
The knowledge regarding the effect of lifestyle factors on cancer risk and cancer prevention lifestyle recommendations will be assessed via a knowledge score derived from the General Nutrition \& Physical Activity Knowledge Questionnaires
Improvement in lifestyle score assessed via lifestyle questionnaires
Time frame: 1 year
WCRF lifestyle score will be assessed through lifestyle questionnaires. Compliance with the WCRF recommendations is considered achieved if this WCRF lifestyle score increases to more than 5 out of 8. The following questionnaires will be used to assess lifestyle changes: French EPIC food frequency questionnaire; the International Physical Activity Questionnaires - IPAQ; Weight and height measurements to assess BMI.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- 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.
Marc J Gunter, PhD principal investigator
International Agency for Research on Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy. in people with Colorectal Cancer, run by International Agency for Research on Cancer at 1 site 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc J Gunter, PhD (0033472738093, GunterM@iarc.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knowledge score assessed via a knowledge questionnaire (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Oct 2023.