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

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 Overview

• Status: Completed
• Conditions: Colorectal Cancer Prevention
• Intervention / Treatment: Behavioral: Low risk; Behavioral: Moderate risk; Behavioral: High risk

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Centre Léon Bérard (CLB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Risk sub-group; st sub-grouup : Low risk to develop a CRC; nd sub-group : Moderate risk to develop a CRC; rd sub-group : High risk to develop a CRC

Behavioral: Low risk; remote support in physical activity and nutrition via digital media; monthly collective physical activity sessions; logbook; Behavioral: Moderate risk; remote support in physical activity and nutrition via digital media; monthly collective physical activity sessions; one collective health education session; logbook; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the programme feasability	Participation rate at each modality of the programme	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the programme acceptability	Participation rate to the study (number of participants/number of eligible persons)	Month 6
Assessment of the programme acceptability	Satisfaction, assessed by a Likert scale on a self-administered questionnaire	Month 6
Assessment of the programme observance	Evaluate the observance to the whole programme, for each subgroup	Month 6
Assessment of the evolution of lifestyle	World Cancer Research Fund international questionnaire Score : from 0 (worse score) to 7 (better score)	Month 6
Assessment of the physical activity level change	Evaluate the effects on physical activity level using the IPAQ	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)	Month 6

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Anne CATTEY-JAVOUHEY, MD, PhD, Centre Léon Bérard

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2022
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PRECÔTION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No