Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches
NCT ID: NCT05568667
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2022-10-17
2023-12-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Risk sub-group
1. st sub-grouup : Low risk to develop a CRC
2. nd sub-group : Moderate risk to develop a CRC
3. rd sub-group : High risk to develop a CRC
Low risk
* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* logbook
Moderate risk
* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* logbook
High risk
* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* 3 individual sessions of motivational coaching
* connected watch
* logbook
Interventions
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Low risk
* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* logbook
Moderate risk
* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* logbook
High risk
* remote support in physical activity and nutrition via digital media
* monthly collective physical activity sessions
* one collective health education session
* 3 individual sessions of motivational coaching
* connected watch
* logbook
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* NI2. With a contraindication to pratice physical activity (e.g. uncontrolled hypertension, uncontrolled heart disease),
* 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,
* NI6. Concurrent participation in another PA or nutrition study,
* NI7. (For women) Pregnant.
18 Years
80 Years
ALL
Yes
Sponsors
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Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Anne CATTEY-JAVOUHEY, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Léon Bérard (CLB)
Lyon, , France
Countries
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Other Identifiers
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PRECÔTION
Identifier Type: -
Identifier Source: org_study_id
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