Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches

NCT05568667 | Completed

• 1 other identifier: PRECÔTION
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer Prevention

Outcome Measures

Primary Outcomes (1)

• Assessment of the programme feasability

  Participation rate at each modality of the programme

  Month 6

Secondary Outcomes (6)

• Assessment of the programme acceptability

  Month 6

• Assessment of the programme acceptability

  Month 6

• Assessment of the programme observance

  Month 6

• Assessment of the evolution of lifestyle

  Month 6

• Assessment of the physical activity level change

  Month 6

Study Arms (1)

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

Behavioral: Low risk; Behavioral: Moderate risk; Behavioral: High risk

Interventions

Low risk BEHAVIORAL

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

Risk sub-group

Moderate risk BEHAVIORAL

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

Risk sub-group

High risk BEHAVIORAL

* 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

Risk sub-group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• I1. Adult aged ≤ 80 years,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard (CLB)

Lyon, 69008, France

Location

MeSH Terms

Interventions

AIEOP acute lymphoblastic leukemia protocol

Study Officials

• Anne CATTEY-JAVOUHEY, MD, PhD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 17, 2022
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: February 12, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)