A Program for Improved Family Screening for Colorectal Cancer (COLOR3)
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Personalized intervention
Sponsored by
About this trial
This is an interventional prevention trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- INGRANDRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
personalized intervention
Arm Description
Personalized intervention by a preventive nurse, relying on validated prevention models, in improving participation in the colonoscopic screening of siblings
Outcomes
Primary Outcome Measures
Evaluation of coordinated transmission
Colonoscopies carried out by relatives
Secondary Outcome Measures
Evaluation of doctors' sensitization to the recommendations.
Group interviews with physicians to bring together their opinions and to validate the program modalities
Adherence to personalized intervention
On-telephone and face-to-face interviews with physicians and relatives.
Full Information
NCT ID
NCT03620877
First Posted
June 21, 2018
Last Updated
February 2, 2021
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03620877
Brief Title
A Program for Improved Family Screening for Colorectal Cancer
Acronym
COLOR3
Official Title
A Program for Improved Family Screening for Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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.
Description of the intervention: This program, offered in 4 departments is divided into 3 phases:
Sensitization of doctors to the recommendations. This is a collaborative work with clinicians to enable them i) to take ownership of the problem and generic documents used in the previous study and ii) to define an intervention logic to encourage them to systematically inform subjects with RCC or advanced adenoma before age 65 the increased risk related to their 1st degree.
Coordinated transmission of information from the patient's physician to the relative's physician under consent of the patient and his/her relatives. Under the terms established with the actors in the previous phase, the physician delivers standard information to the index patient, presents the generic documents and may adapt the procedure to each patient's needs. With support of the coordination team which collects the coordinates of 1st degree relatives, the patient's physician transmits the information to the relatives and their doctors. The coordination team, during this experimental phase, will be the team of Epidemiology, Cancer Registry of Poitiers University Hospital, under the responsibility of public health physicians. The coordination team contacts each relative on behalf of the index patient's consent, acting by delegation of the index patient's physician, informs about the transmission of information given to the index patient, requests the agreement of the relative that the patient's doctor would contact his/her doctor to inform, under cover of professional secrecy, of the medical context.
Personalized information of relatives by a preventive nurse based on validated prevention models (individual psychosocial factors associated with screening and behavioral stage). At most two years after diagnosis of the index patient, the relative's colonoscopy performance status will be ascertained by the coordination team in connection with the attending physician. If the relative has had a colonoscopy carried out, the coordination team shall document the results and note the date scheduled for the following exam. If the relative has not had a colonoscopy carried out, he shall then receive a personalized intervention, based on the intervention evaluated in the previous study, as a supplement to the action of his/her doctor.
Qualitative and quantitative evaluations will follow each phase to measure the acceptability, coverage, efficiency, to assess transferability of the program. Moreover the program will be evaluated by a population survey conducted by the cancer registry that covers the geographical area of the experimentation with data collection that identify exhaustively the patients with CRC or high-grade adenoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
personalized intervention
Arm Type
Experimental
Arm Description
Personalized intervention by a preventive nurse, relying on validated prevention models, in improving participation in the colonoscopic screening of siblings
Intervention Type
Behavioral
Intervention Name(s)
Personalized intervention
Intervention Description
Personalized intervention by a preventive nurse, relying on validated prevention models, in improving participation in the colonoscopic screening of siblings
Primary Outcome Measure Information:
Title
Evaluation of coordinated transmission
Description
Colonoscopies carried out by relatives
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Evaluation of doctors' sensitization to the recommendations.
Description
Group interviews with physicians to bring together their opinions and to validate the program modalities
Time Frame
up to 10 months
Title
Adherence to personalized intervention
Description
On-telephone and face-to-face interviews with physicians and relatives.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre Ingrand, MD, PhD
Phone
33-5.49.45.43.45
Email
pierre.ingrand@univ-poitiers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle Ingrand, PhD
Phone
33-5.49.45.42.35
Email
isabelle.ingrand@univ-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Ingrand, MD, PhD
Organizational Affiliation
University Hospital, Poitiers, France
Official's Role
Study Director
Facility Information:
Facility Name
INGRAND
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
INGRAND Pierre, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
16338133
Citation
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.
Results Reference
background
PubMed Identifier
27537555
Citation
Ingrand 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.
Results Reference
background
PubMed Identifier
20602807
Citation
Taouqi 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.
Results Reference
background
PubMed Identifier
19683486
Citation
Ingrand 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.
Results Reference
background
PubMed Identifier
19920944
Citation
Ingrand 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.
Results Reference
background
PubMed Identifier
26584600
Citation
Ng 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.
Results Reference
background
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A Program for Improved Family Screening for Colorectal Cancer
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