An interventional study of Therapeutic Education Strategy in Cancer Colorectal, sponsored by University Hospital, Tours. Completed at 8 sites in France. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Prevention
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.
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.
1,485 studies on the registry are indexed under Colonic Neoplasms; 362 are open to participants now.
This study's enrollment of 68 is below the median of 89 across 1,067 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University Hospital, Tours is the lead sponsor of 306 studies on the registry; 78 are open to participants now.
Counted across the registry records on this site, refreshed daily.
List of inclusion criteria
Index case:
Related:
List of exclusion Criteria :
Index case :
Related :
- Not applicable
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'
Behavioral: Therapeutic Education Strategy
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
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).
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.
Time frame: 12 MONTHS
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.
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.
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.
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.
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 to access the colonoscopy (time between the procedure and the completion of the screening colonoscopy).
Time frame: 2 MONTHS
Rate of colorectal cancer.
Rate of colorectal cancer.
Time frame: 12 MONTHS
Rate of advanced adenomas.
Rate of advanced adenomas.
Time frame: 12 MONTHS
Detection rate of scallop lesions.
Detection rate of scallop lesions.
Time frame: 12 MONTHS
Rate of complications in screening colonoscopies.
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.
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
Ran from Apr 2017 to primary completion in Jan 2019, 21 months.
Of 290 non-industry interventional studies with no phase under Colonic Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 60. This study's 21 months is below that.
Counting every sponsor, half of 300 studies reached it within 32 months; a quarter within 18 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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