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Completed

NCT Number: NCT05568667

Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches

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.

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Key information

Conditions

Colorectal Cancer Prevention

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard (CLB)

Lyon, 69008, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low risk

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

Moderate risk

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

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

Primary outcomes

  1. Assessment of the programme feasability

    Time frame: Month 6

    Participation rate at each modality of the programme

Secondary outcomes

  1. Assessment of the programme acceptability

    Time frame: Month 6

    Participation rate to the study (number of participants/number of eligible persons)

  2. Assessment of the programme acceptability

    Time frame: Month 6

    Satisfaction, assessed by a Likert scale on a self-administered questionnaire

  3. Assessment of the programme observance

    Time frame: Month 6

    Evaluate the observance to the whole programme, for each subgroup

  4. Assessment of the evolution of lifestyle

    Time frame: Month 6

    World Cancer Research Fund international questionnaire Score : from 0 (worse score) to 7 (better score)

  5. Assessment of the physical activity level change

    Time frame: Month 6

    Evaluate the effects on physical activity level using the IPAQ

  6. Assessment of the evolution on CRC risk factors knowledge

    Time frame: Month 6

    Self-administered questionnaire (questionnaire specially designed for the study, no titlle) Score : from 0 (worse score) to 9 (better score)

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 6, 2022
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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