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NCT Number: NCT03084133

Impact of EDUcation Strategy on Patients With COLorectal CANCER or Advanced Adenoma in the Detection of Colorectal Cancer of Their First-degree Relatives

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.

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Key information

Conditions

Cancer Colorectal Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service d'Hépatogastro-entérologie CHU ANGERS, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Therapeutic Education Strategy

Behavioral

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.

    Time frame: 12 MONTHS

    Psychological determinants (quality of relationship with relatives, motivation to inform relatives) that can condition the enrollment in the education program.

  2. 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 in index cases associated with screening colonoscopy in related subjects: age, sex, educational level, socio-professional category.

  3. Social and demographic factors 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.

  4. How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.

    Time frame: 12 MONTHS

    How to access screening colonoscopy: pathway (public or private), direct access to the gastroenterologist or through the attending physician.

  5. Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).

    Time frame: 2 MONTHS

    Time to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).

  6. Rate of colorectal cancer.

    Time frame: 12 MONTHS

    Rate of colorectal cancer.

  7. Rate of advanced adenomas.

    Time frame: 12 MONTHS

    Rate of advanced adenomas.

  8. Detection rate of scallop lesions.

    Time frame: 12 MONTHS

    Detection rate of scallop lesions.

  9. Rate of complications in screening colonoscopies.

    Time frame: 12 MONTHS

    Rate of complications in screening colonoscopies.

  10. 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

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Centre Hospitalier de Dreux
  • Clinic LE MANS
  • Hospital BLOIS
  • Hospital LOCHES
  • Nantes University Hospital
  • Poitiers University Hospital
  • University Hospital, Angers
  • University of New Orleans

Registry information

Official study 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

Acronym: EDUCANCOLAGE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 20, 2017
Registry last updated
Sep 26, 2019

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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