NCT05568667Completed
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches
Pilot Study to Improve Primary Prevention of Colorectal Cancer by Motivational and Community-based Approaches, According to Individual Risk Level, in People Undergoing Colonoscopy
Source: ClinicalTrials.gov · Last updated 12 Feb 2024
Brief summary (registry, in English)
It has been estimated that 19,000 Colorectal Cancers (CRC) could be prevented each year in France by changing individual risk behaviours (sedentary lifestyle, overweight, diet, alcohol). The cancer screening appears to be an opportune moment for health promotion and to inform about CRC risk factors. The PRECÔTION study proposes an innovative scheme based on informative, motivational and community-based approaches. The objectives are to take advantage of patients' visits for colonoscopy to raise awareness and initiate individual prevention actions according to their own risk in order to modify individual risk behaviour. Patients who come for a colonoscopy at the Centre Léon Bérard and who are negative (80% of cases) will benefit from an evaluation to identify their individual risk factors, determine their level of risk level for CRC and their motivation to change their behaviour. Participants with a low level of risk will receive remote support in physical activity and nutrition via digital media based on a motivational approach. Participants will be proposed a monthly collective physical activity session, which will allow them to interact with each other and develop a community approach. Participants with an intermediate level of risk will be offered a collective health education session, in addition to the the support offered to participants with a low level of risk. Participants with a high level of risk will receive, in addition to the the support offered to participants with an intermediate level of risk, an individual motivational coaching and a connected watch. A logbook will also be given to all participants to accompany them on the different tools, especially for monitoring their goals. The PRECÔTION study aims to evaluate these tools as innovative means of prevention before evaluate their effectiveness on a larger scale.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 3 Oct 2022
- Start date
- 17 Oct 2022
- Primary completion date
- 6 Dec 2023
- Lead sponsor
- Centre Leon Berard
- Diseases
- Colorectal cancer
- NCT number
- NCT05568667
What you commit to
- Study type: Interventional
- Participants enrolled: 90
- From 17 Oct 2022 to the primary completion date, 6 Dec 2023
- 1 site 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
- NI6. Concurrent participation in another PA or nutrition study,
Other illness
- NI1. Presence of a primary cancer (other than in situ cancer of any location and/or basal cell skin cancer) - NB : people in complete remission from a previous cancer may be included,
- NI2. With a contraindication to pratice physical activity (e.g. uncontrolled hypertension, uncontrolled heart disease),
Other
- NI3. Severe undernutrition (HAS) (i.e. weight loss ≥ 10% in 1 month or ≥ 15% in 6 months or ≥ 15% compared to usual weight or body mass index ≤ 17 kg/m² for a person \< 70 ans or body mass index \< 20 kg/m² for a person ≥ 70 ans)
- NI4. Unable to be followed for medical, social, family, geographical or psychological reasons throughout the study,
- NI5. Deprived of liberty by judicial or administrative decision,
- NI7. (For women) Pregnant.
Who the study is looking for
- I1. Adult aged ≤ 80 years,
- I2. Having undergone in the month prior to inclusion a colonoscopy for CRC screening, with a negative result,
- I3. Willing to be involved throughout the study,
- I4. Able to practice a adapted physical activity (APA) certified by a medical certificate issued by the referring oncologist or the clinical investigator,
- I5. Using a own smartphone, a tablet or a PC with Internet connexion,
- I6. Having a valid health insurance affiliation,
- I7. Having dated and signed an informed consent form,
- I8. Able to read, write and understand French.
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Léon Berard (CLB) Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.