EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST. (SUIVICOLO)

Официальное название

EFFECTIVENESS OF EARLY INFORMATION AND ENDORSMENT BY GP TO INCREASE COLONOSCOPY FOLLOW-UP AND REDUCE DELAYS IN PEOPLE WITH A POSITIVE COLORECTAL CANCER SCREENING TEST, A RANDOMISED CONTROLLED TRIAL. (SUIVICOLO)

Обзор

To be effective, organized colorectal cancer screening requires good adherence to diagnostic colonoscopy in the event of a positive test. In France, the rate of diagnostic colonoscopy following a positive colorectal cancer screening test is less than 85%, and the median delay is close to 90 days. After receiving their positive result from the laboratory, individuals with no known follow-up are contacted only six months later by the Regional Cancer Screening Coordination Centers (CRCDC) responsible for following up with individuals who have tested positive. To optimize follow-up with colonoscopy, earlier contact and information about colonoscopy appear to be necessary. The contribution of the general practitioner identified on the test could be an additional lever. The SUIVICOLO study aims to evaluate the effectiveness on the rate of colonoscopies performed at 6 months of two strategies for optimizing the follow-up of positive results in comparison with control group C (current procedures of the CRCDC Centre Val de Loire without early letter). The two strategies evaluated will be: * Group B1: Sending an early letter signed by the CRCDC accompanied by information leaflet about colonoscopy * Group B2: Sending an early letter co-signed by the CRCDC and the general practitioner (identified or provided by the patient on the test identification form) accompanied by information leaflet about colonoscopy. These strategies will be compared to the current follow-up strategy in a three arm randomized controlled arm.

Вмешательства

• Другое Usual care follow-up by CRCDC
  1. 6 months after positive test result: 1st reminder letter from the CRCDC if it has no information about a colonoscopy being performed 2. 12 months after positive test result: 2nd reminder letter from the CRCDC if it has no information about a colonoscopy being performed 3. 18 months after positive test result: 3rd reminder letter from the CRCDC if it has no information about a colonoscopy being performed
• Другое Information leaflet about colonoscopy follow-up
  An information leaflet about colonoscopy follow-up will be sent in an early letter 7 days after positive test result, and though QR-codes in subsequent reminders.
• Другое Endorsement of CRCDC letters from the GP
  Explicit mention of their general practitioner in letters and reminders sent by the CRCDC to individuals who have tested positive for colorectal cancer, including the information leaflet about colonoscopy or a link to this document (QR code).

Первичные конечные точки

• Colonoscopy rate at 6 months after a positive test [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Percentage of general practitioners who agreed to participate in the project [Срок оценки: At baseline]
• Colonoscopy rates at 12 months after a positive test [Срок оценки: 12 months]
• Colonoscopy rates at 18 months after a positive test [Срок оценки: 18 months]
• Colonoscopy rates at 24 months after a positive test [Срок оценки: 24 months]
• Number of reminders in each group by type of reminder [Срок оценки: 24 months]
• Number of people with contraindications to colonoscopy [Срок оценки: 24 months]
• Number of people with a CT colonography [Срок оценки: 24 months]
• Time to perform colonoscopy [Срок оценки: 24 months]
• Colorectal cancer at colonoscopy [Срок оценки: 24 months]
• Advanced neoplasia at colonoscopy [Срок оценки: 24 months]
• Number of people who refused colonoscopy [Срок оценки: 24 months]
• Number of lost to follow-up [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Aged between 50 and 75 at the time of the positive colorectal cancer screening test

• Residing in one of the departments of the Centre Val de Loire region
• Date on which the positive CRC screening test result was sent to the beneficiary recorded
• Colorectal cancer screening test results sent to the beneficiary within 30 days of the test being read
• Affiliated with a health insurance fund

Критерии исключения

• Subjects who have notified their refusal to allow their data to be used for research purposes will be excluded from the analyses.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 1 центр

• Crcdc-Cvl — Tours

Идентификаторы

NCT: NCT07520578 · 2025-A01519-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗