Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05568667
Enrollment
90
Registered
2022-10-06
Start date
2022-10-17
Completion date
2023-12-06
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Prevention

Brief 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. 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.

Interventions

BEHAVIORALLow risk

* remote support in physical activity and nutrition via digital media * monthly collective physical activity sessions * logbook

BEHAVIORALModerate risk

* remote support in physical activity and nutrition via digital media * monthly collective physical activity sessions * one collective health education session * logbook

BEHAVIORALHigh 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

Sponsors

Centre Leon Berard
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the programme feasabilityMonth 6Participation rate at each modality of the programme

Secondary

MeasureTime frameDescription
Assessment of the programme acceptabilityMonth 6Participation rate to the study (number of participants/number of eligible persons)
Assessment of the programme observanceMonth 6Evaluate the observance to the whole programme, for each subgroup
Assessment of the evolution of lifestyleMonth 6World Cancer Research Fund international questionnaire Score : from 0 (worse score) to 7 (better score)
Assessment of the physical activity level changeMonth 6Evaluate the effects on physical activity level using the IPAQ
Assessment of the evolution on CRC risk factors knowledgeMonth 6Self-administered questionnaire (questionnaire specially designed for the study, no titlle) Score : from 0 (worse score) to 9 (better score)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026