A Program for Improved Family Screening for Colorectal Cancer
COLOR3
1 other identifier
interventional
500
1 country
1
Brief Summary
A first- degree family history of colorectal cancer (CRC) or adenoma before age 65 is associated with a high risk of CRC. For these high-risk subjects, the French 2013 recommendations advise colonoscopy screening, but participation is insufficient (26-54%).The purpose of this project is to propose, through association of multidisciplinary research teams (public health, sociology, linguistic), actors on the field (physicians, organized screening facilities), and decision makers, relevant and effective interventions in the framework of a public health program, enabling increased participation of relatives of patients with CRC or adenoma before age 65 in targeted screening for CRC by colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Sep 2018
Typical duration for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 8, 2018
CompletedStudy Start
First participant enrolled
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedFebruary 3, 2021
February 1, 2021
2.9 years
June 21, 2018
February 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of coordinated transmission
Colonoscopies carried out by relatives
18 months
Secondary Outcomes (2)
Evaluation of doctors' sensitization to the recommendations.
up to 10 months
Adherence to personalized intervention
24 months
Study Arms (1)
personalized intervention
EXPERIMENTALPersonalized intervention by a preventive nurse, relying on validated prevention models, in improving participation in the colonoscopic screening of siblings
Interventions
Personalized intervention by a preventive nurse, relying on validated prevention models, in improving participation in the colonoscopic screening of siblings
Eligibility Criteria
You may qualify if:
- First-degree relatives of an index patient: father, mother, children, brothers and sisters (aged more than 18 years).
- Informed and oral consent of the participant after clear and fair information on the study
You may not qualify if:
- The persons concerned by the articles L.1121-5 to L1121-8 and L.1122-1-2 of the Code de la santé publique will not be included in the interviews of the qualitative studies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
INGRAND
Poitiers, 86000, France
Related Publications (6)
Butterworth AS, Higgins JP, Pharoah P. Relative and absolute risk of colorectal cancer for individuals with a family history: a meta-analysis. Eur J Cancer. 2006 Jan;42(2):216-27. doi: 10.1016/j.ejca.2005.09.023. Epub 2005 Dec 9.
PMID: 16338133BACKGROUNDIngrand I, Defossez G, Richer JP, Tougeron D, Palierne N, Letard JC, Beauchant M, Ingrand P. Colonoscopy uptake for high-risk individuals with a family history of colorectal neoplasia: A multicenter, randomized trial of tailored counseling versus standard information. Medicine (Baltimore). 2016 Aug;95(33):e4303. doi: 10.1097/MD.0000000000004303.
PMID: 27537555BACKGROUNDTaouqi M, Ingrand I, Beauchant M, Migeot V, Ingrand P. Determinants of participation in colonoscopic screening by siblings of colorectal cancer patients in France. BMC Cancer. 2010 Jul 6;10:355. doi: 10.1186/1471-2407-10-355.
PMID: 20602807BACKGROUNDIngrand I, Dujoncquoy S, Beauchant M, Letard JC, Migeot V, Ingrand P. General practitioner and specialist views on colonoscopic screening of first-degree relatives of colorectal cancer patients. Cancer Epidemiol. 2009 Oct;33(3-4):223-30. doi: 10.1016/j.canep.2009.07.002. Epub 2009 Aug 3.
PMID: 19683486BACKGROUNDIngrand I, Dujoncquoy S, Migeot V, Ghadi V, Beauchant M, Ingrand P. Interactions among physicians, patients, and first-degree relatives in the familial screening of colorectal cancer in France. Patient Prefer Adherence. 2008 Feb 2;2:47-55.
PMID: 19920944BACKGROUNDNg SC, Lau JY, Chan FK, Suen BY, Tse YK, Hui AJ, Leung-Ki EL, Ching JY, Chan AW, Wong MC, Ng SS, To KF, Wu JC, Sung JJ. Risk of Advanced Adenomas in Siblings of Individuals With Advanced Adenomas: A Cross-Sectional Study. Gastroenterology. 2016 Mar;150(3):608-16; quiz e16-7. doi: 10.1053/j.gastro.2015.11.003. Epub 2015 Nov 14.
PMID: 26584600BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pierre Ingrand, MD, PhD
University Hospital, Poitiers, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2018
First Posted
August 8, 2018
Study Start
September 24, 2018
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
February 3, 2021
Record last verified: 2021-02