search
Back to results

Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches

Primary Purpose

Colorectal Cancer Prevention

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Low risk
Moderate risk
High risk
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer Prevention

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre Léon Bérard (CLB)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Risk sub-group

Arm Description

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

Outcomes

Primary Outcome Measures

Assessment of the programme feasability
Participation rate at each modality of the programme

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2022
Last Updated
March 21, 2023
Sponsor
Centre Leon Berard
search

1. Study Identification

Unique Protocol Identification Number
NCT05568667
Brief Title
Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
December 17, 2023 (Anticipated)
Study Completion Date
December 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Risk sub-group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Low risk
Intervention Description
remote support in physical activity and nutrition via digital media monthly collective physical activity sessions logbook
Intervention Type
Behavioral
Intervention Name(s)
Moderate risk
Intervention Description
remote support in physical activity and nutrition via digital media monthly collective physical activity sessions one collective health education session logbook
Intervention Type
Behavioral
Intervention Name(s)
High risk
Intervention Description
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 Outcome Measure Information:
Title
Assessment of the programme feasability
Description
Participation rate at each modality of the programme
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Assessment of the programme acceptability
Description
Participation rate to the study (number of participants/number of eligible persons)
Time Frame
Month 6
Title
Assessment of the programme acceptability
Description
Satisfaction, assessed by a Likert scale on a self-administered questionnaire
Time Frame
Month 6
Title
Assessment of the programme observance
Description
Evaluate the observance to the whole programme, for each subgroup
Time Frame
Month 6
Title
Assessment of the evolution of lifestyle
Description
World Cancer Research Fund international questionnaire Score : from 0 (worse score) to 7 (better score)
Time Frame
Month 6
Title
Assessment of the physical activity level change
Description
Evaluate the effects on physical activity level using the IPAQ
Time Frame
Month 6
Title
Assessment of the evolution on CRC risk factors knowledge
Description
Self-administered questionnaire (questionnaire specially designed for the study, no titlle) Score : from 0 (worse score) to 9 (better score)
Time Frame
Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélia MAIRE, MSc
Phone
0469856362
Email
aurelia.maire@lyon.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia PEROL, MSc
Phone
0478782897
Email
olivia.perol@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne CATTEY-JAVOUHEY, MD, PhD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard (CLB)
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aurélia MAIRE, MSc
Phone
0469856362
Email
aurelia.maire@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Olivia PEROL, MSc
Phone
0478782897
Email
olivia.perol@lyon.unicancer.fr
First Name & Middle Initial & Last Name & Degree
Anne CATTEY-JAVOUHEY, MD, PhD
First Name & Middle Initial & Last Name & Degree
Pamela FUNK-DEBLEDS, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improve Colorectal Cancer Prevention by Motivational and Community-based Approaches

We'll reach out to this number within 24 hrs