Colorectal Cancer PreventionNCT05568667
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches
A study testing Low risk, Moderate risk and High risk in people with Colorectal Cancer Prevention, run by Centre Leon Berard at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Prevention
- What is being tested?
- Low risk, Moderate risk and High risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2022to 6 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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),
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Improve Primary Prevention of Colorectal Cancer by Motivational and Community-based Approaches, According to Individual Risk Level, in People Undergoing Colonoscopy
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.
Read more
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.
- Conditions
- Colorectal Cancer Prevention
- Being tested
- Low risk, Moderate risk, High risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low riskBehavioural
- remote support in physical activity and nutrition via digital media
- monthly collective physical activity sessions
- logbook
Moderate riskBehavioural
- remote support in physical activity and nutrition via digital media
- monthly collective physical activity sessions
- one collective health education session
- logbook
High riskBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| Risk sub-group | Experimental | 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 Receives: Behavioral: Low risk; Behavioral: Moderate risk; Behavioral: High risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the programme feasability
Participation rate at each modality of the programme
Measured: Month 6
Secondary outcomes (6)
Assessment of the programme acceptability
Participation rate to the study (number of participants/number of eligible persons)
Measured: Month 6
Assessment of the programme acceptability
Satisfaction, assessed by a Likert scale on a self-administered questionnaire
Measured: Month 6
Assessment of the programme observance
Evaluate the observance to the whole programme, for each subgroup
Measured: Month 6
Assessment of the evolution of lifestyle
World Cancer Research Fund international questionnaire Score : from 0 (worse score) to 7 (better score)
Measured: Month 6
Assessment of the physical activity level change
Evaluate the effects on physical activity level using the IPAQ
Measured: Month 6
Assessment of the evolution on CRC risk factors knowledge
Self-administered questionnaire (questionnaire specially designed for the study, no titlle) Score : from 0 (worse score) to 9 (better score)
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start17 Oct 2022
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer PreventionStudies 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
- 90 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
- NCT05568667
- Sponsor's protocol ID
- PRECÔTION
- Status last verified
- Mar 2023
- First submitted
- 3 Oct 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
- Pilot Study to Improve Primary Prevention of Colorectal Cancer by Motivational and Community-based Approaches, According to Individual Risk Level, in People Undergoing Colonoscopy
- ClinicalTrials.gov ID
- NCT05568667
- Acronym / sponsor ID
- PRECÔTION
- Conditions
- Colorectal Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 6 Oct 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Risk sub-group | Experimental | Behavioral: Low risk, Behavioral: Moderate risk, Behavioral: High risk1. 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (7 listed)
- 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),
- 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,
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 |
|---|---|---|
| Low risk* remote support in physical activity and nutrition via digital media * monthly collective physical activity sessions * logbook | Behavioural | Risk sub-group |
| Moderate risk* remote support in physical activity and nutrition via digital media * monthly collective physical activity sessions * one collective health education session * logbook | Behavioural | Risk sub-group |
| 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 | Behavioural | Risk sub-group |
Primary outcome
Assessment of the programme feasability
Time frame: Month 6
Participation rate at each modality of the programme
6 secondary outcomes
Assessment of the programme acceptability
Time frame: Month 6
Assessment of the programme acceptability
Time frame: Month 6
Assessment of the programme observance
Time frame: Month 6
Assessment of the evolution of lifestyle
Time frame: Month 6
Assessment of the physical activity level change
Time frame: Month 6
Assessment of the evolution on CRC risk factors knowledge
Time frame: Month 6
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low risk, Moderate risk and High risk in people with Colorectal Cancer Prevention, run by Centre Leon Berard 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 8 inclusion and 7 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 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?
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?
Assessment of the programme feasability (time frame: Month 6). 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.