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A Program for Improved Family Screening for Colorectal Cancer

A Program for Improved Family Screening for Colorectal Cancer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03620877
Acronym
COLOR3
Enrollment
500
Registered
2018-08-08
Start date
2018-09-24
Completion date
2021-09-30
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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: 1. 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. 2. 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. 3. 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.

Interventions

Personalized intervention by a preventive nurse, relying on validated prevention models, in improving participation in the colonoscopic screening of siblings

Sponsors

Poitiers University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of coordinated transmission18 monthsColonoscopies carried out by relatives

Secondary

MeasureTime frameDescription
Evaluation of doctors' sensitization to the recommendations.up to 10 monthsGroup interviews with physicians to bring together their opinions and to validate the program modalities
Adherence to personalized intervention24 monthsOn-telephone and face-to-face interviews with physicians and relatives.

Countries

France

Contacts

Primary ContactPierre Ingrand, MD, PhD
pierre.ingrand@univ-poitiers.fr33-5.49.45.43.45
Backup ContactIsabelle Ingrand, PhD
isabelle.ingrand@univ-poitiers.fr33-5.49.45.42.35

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026