Cancer ColorectalEDUCANCOLAGENCT03084133
Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives
A study testing Therapeutic Education Strategy in people with Cancer Colorectal, run by University Hospital, Tours at 8 sites in France.
Trial summary
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cancer Colorectal
- What is being tested?
- Therapeutic Education Strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 8 sitesFrance
- Study dates
- 10 Apr 2017to 19 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
List of inclusion criteria
Index case:
- Patients with colorectal adenocarcinoma or advanced adenoma diagnosed (definition of advanced adenoma (Winawer, 2006): adenoma of diameter ≥ 10 mm and / or severe dysplasia and / or with a villous contingent).
- Patients with at least one relative of the first degree belonging to the target population of the screening strategy evaluated (between 40 and 75 years of age and less than 10 years of age of the case-index) and residing in France.
- Affiliation of the patient to a social security scheme (including CMU).
- Understanding of the French language.
Related:
- They correspond to the target population at high risk of colorectal cancer targeted by this program of promotion of colonoscopy screening:
- Subjects related to 1st degree to the index case and in contact with it.
- Age between 40 and 75 years of age or less than 10 years of age of the index case.
- Resides in France
List of exclusion Criteria :
Index case :
- Chronic inflammatory bowel disease.
- Genetic predisposition syndrome identified with colorectal cancer (Lynch syndrome, familial polyposis linked to the APC and MYH genes).
- Patient's knowledge of a first-degree relative with colorectal adenocarcinoma or advanced adenoma.
- Isolated patient of his / her first-degree relatives and not wishing to re-establish contact with them.
- Advanced colorectal cancer with a life expectancy <6 months and / or a WHO ≥ 2 general condition.
- Transmission of information to the family already carried out.
Related :
- Not applicable
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Service d'Hépatogastro-entérologie CHU ANGERS
Angers
Service d'Hépatogastro-entérologie CHG BLOIS
Blois, 41 000
Service d'Hépatogastro-entérologie CHG de DREUX
Dreux
Service de Médecine CHG de Loches
Loches
Service d'Hépatogastro-entérologie CHU de NANTES
Nantes
Service d'Hépatogastro-entérologie CHR d'Orléans
Orléans, 45067
Service d'Hépatogastro-entérologie CHU POITIERS
Poitiers, 86 000
Service d'Hépatogastro-entérologie CHRU de TOURS
Tours, 37044
About this study
Official title: Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives - Randomized, Multicenter Cluster Test
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.
The main reason for this low participation rate is that most patients undergoing RCC or advanced adenoma are unaware of the family implications of their diagnosis and therefore reluctant to disseminate this information to their patients Related matters. The need for a better perception of the personal risk of CRC in first-degree relatives of patients with CRC or advanced adenoma, with the expected coronary adherence to increasing screening, requires a good understanding of risk through Clear, adapted and comprehensible information that can be relayed personally by the case-index.
Read more
The objective of this project is to develop a personalized prevention and screening program for the JRC in order to meet the needs of the relatives of the sick. The means of intervention that will be implemented respond to the need to better take into account the level of CRC risk in a family-based CRC screening and prevention approach adapted to a high-risk CRC group characterized by Family history at the first stage of CRC or advanced adenoma and, consequently, to improve the information of the subjects concerned by screening and prevention of CRC.
The aim of the case-index education is to induce its intervention with its relatives to promote CCR screening. The use of the index case, as a means of providing information to relatives, implies an educational and psychological approach, based on evidence, but adapted and personalized.
Read the detailed description
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.
- Conditions
- Cancer Colorectal
- Being tested
- Therapeutic Education Strategy
- Keywords
- Therapeutic education strategy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Education StrategyBehavioural
In the experimental arm of the study ("intervention group"), a screening information and education system will be implemented. The particularities of the index cases likely to require an adaptation of the device will be collected, analyzed and taken into account (level of health literacy, socio-economic status, level of education, professional activity ...). The analysis and intervention frameworks derived from theories on health behaviors will be mobilized (theory of reasoned action, theory of planned behaviors) and applied in order to reinforce the "intention" of the target audience. The analysis and intervention frameworks resulting from the educational sciences will be integrated with a "competence" approach (Aizen, 1991, Denovel, Dufour, Prochaska, 1983, Le Boterf, 2002).
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Education Strategy | Experimental | Means a screening information and education system in which the particularities of the index cases likely to require adaptation of the device will be collected, analyzed and taken into account.
Intervention 'Therapeutic Education Strategy' Receives: Behavioral: Therapeutic Education Strategy |
| Control group | No intervention | Provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the index case according to its usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Measured: 12 MONTHS
Secondary outcomes (10)
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Measured: 12 MONTHS
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Measured: 12 MONTHS
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Measured: 12 MONTHS
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
Measured: 12 MONTHS
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Measured: 2 MONTHS
Rate of colorectal cancer.
Rate of colorectal cancer.
Measured: 12 MONTHS
Rate of advanced adenomas.
Rate of advanced adenomas.
Measured: 12 MONTHS
Detection rate of scallop lesions.
Detection rate of scallop lesions.
Measured: 12 MONTHS
Rate of complications in screening colonoscopies.
Rate of complications in screening colonoscopies.
Measured: 12 MONTHS
Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.
Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.
Measured: 12 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start10 Apr 2017
- Primary completion19 Jan 2019
- Study completion19 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ColorectalStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- "Intervention group" means a screening information and education system in which the particularities of the index cases likely to require adaptation of the device will be collected, analyzed and taken into account. "Control group": provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the case-index according to its usual practice and adapted to the level of understanding of Case-index.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Angers, Nantes University Hospital, Centre Hospitalier de Dreux, Hospital BLOIS, Hospital LOCHES, Poitiers University Hospital, University of New Orleans, Clinic LE MANS
- Responsible party
- Sponsor
- Investigators
- CAROLI BOSC Françis- Xavier, Pr, Principal investigator, University Hospital, AngersMATYSIAK-BUDNIK Tamara, Pr, Principal investigator, Nantes University HospitalLANDAU Alain, Dr, Principal investigator, CHG DREUXGARGOT Denis, Dr, Principal investigator, CHG BLOISBARBIEUX Jean- Pierre, Dr, Principal investigator, CHG LOCHESTOUGERON David, Pr, Principal investigator, CHU PoitiersLEGOUX Jean- Louis, Dr, Principal investigator, CHR ORLEANSBOURGEOIS Hugues, Dr, Principal investigator, Clinic Victor Hugo LE MANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084133
- Sponsor's protocol ID
- INCA14-TL/EDUCANCOLAGE
- Other IDs
- 2015-A01514-45
- Acronym
- EDUCANCOLAGE
- Status last verified
- Sep 2019
- First submitted
- 28 Feb 2017
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives - Randomized, Multicenter Cluster Test
- ClinicalTrials.gov ID
- NCT03084133
- Acronym / sponsor ID
- EDUCANCOLAGE / INCA14-TL/EDUCANCOLAGE
- Conditions
- Cancer Colorectal
- Keywords
- Therapeutic education strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- University Hospital, Angers, Nantes University Hospital, Centre Hospitalier de Dreux, Hospital BLOIS, Hospital LOCHES, Poitiers University Hospital, University of New Orleans, Clinic LE MANS
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 19 Jan 2019 (actual)
- Study completion
- 19 Jan 2019 (actual)
- First posted
- 20 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.
The main reason for this low participation rate is that most patients undergoing RCC or advanced adenoma are unaware of the family implications of their diagnosis and therefore reluctant to disseminate this information to their patients Related matters. The need for a better perception of the personal risk of CRC in first-degree relatives of patients with CRC or advanced adenoma, with the expected coronary adherence to increasing screening, requires a good understanding of risk through Clear, adapted and comprehensible information that can be relayed personally by the case-index.
The objective of this project is to develop a personalized prevention and screening program for the JRC in order to meet the needs of the relatives of the sick. The means of intervention that will be implemented respond to the need to better take into account the level of CRC risk in a family-based CRC screening and prevention approach adapted to a high-risk CRC group characterized by Family history at the first stage of CRC or advanced adenoma and, consequently, to improve the information of the subjects concerned by screening and prevention of CRC.
The aim of the case-index education is to induce its intervention with its relatives to promote CCR screening. The use of the index case, as a means of providing information to relatives, implies an educational and psychological approach, based on evidence, but adapted and personalized.
Detailed description
The relative risk of colorectal cancer (CRC) is increased in first-degree relatives of patients with CRC or advanced adenoma. In the high-risk CCR population defined by a family history at the first stage of CRC or advanced adenoma before age 60, total colonoscopy is the recommended screening test. In France, the rate of screening colonoscopy in this population at high risk of CRC is insufficient, which limits the effectiveness of this targeted screening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- "Intervention group" means a screening information and education system in which the particularities of the index cases likely to require adaptation of the device will be collected, analyzed and taken into account. "Control group": provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the case-index according to its usual practice and adapted to the level of understanding of Case-index.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Education Strategy | Experimental | Behavioral: Therapeutic Education StrategyMeans a screening information and education system in which the particularities of the index cases likely to require adaptation of the device will be collected, analyzed and taken into account. Intervention 'Therapeutic Education Strategy' |
| Control group | No intervention | –Provision of information on the need for screening colonoscopy in first-degree relatives of case-index patients by the practitioner taking charge of the index case according to its usual practice |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Education StrategyIn the experimental arm of the study ("intervention group"), a screening information and education system will be implemented. The particularities of the index cases likely to require an adaptation of the device will be collected, analyzed and taken into account (level of health literacy, socio-economic status, level of education, professional activity ...). The analysis and intervention frameworks derived from theories on health behaviors will be mobilized (theory of reasoned action, theory of planned behaviors) and applied in order to reinforce the "intention" of the target audience. The analysis and intervention frameworks resulting from the educational sciences will be integrated with a "competence" approach (Aizen, 1991, Denovel, Dufour, Prochaska, 1983, Le Boterf, 2002). | Behavioural | Therapeutic Education Strategy |
Primary outcome
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
Time frame: 12 MONTHS
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma.
10 secondary outcomes
Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.
Time frame: 12 MONTHS
Social and demographic factors in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Time frame: 12 MONTHS
Social and demographic factors associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.
Time frame: 12 MONTHS
How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.
Time frame: 12 MONTHS
Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Time frame: 2 MONTHS
Rate of colorectal cancer.
Time frame: 12 MONTHS
Rate of advanced adenomas.
Time frame: 12 MONTHS
Detection rate of scallop lesions.
Time frame: 12 MONTHS
Rate of complications in screening colonoscopies.
Time frame: 12 MONTHS
Quality criteria for screening colonoscopy using the following parameters: visualization rate of the bottom of the colon, the withdrawal time of the colonoscope (Withdrawal time), quality of the colic preparation using the Boston scale.
Time frame: 12 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAROLI BOSC Françis- Xavier, Pr principal investigator
University Hospital, Angers
MATYSIAK-BUDNIK Tamara, Pr principal investigator
Nantes University Hospital
LANDAU Alain, Dr principal investigator
CHG DREUX
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Education Strategy in people with Cancer Colorectal, run by University Hospital, Tours at 8 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate in screening colonoscopy for first-degree relatives of patients with RCC or advanced adenoma. (time frame: 12 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.