Centralized Lung Cancer Screening Engagement in At-Risk Populations

Официальное название

Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)

Обзор

This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.

Подробное описание

This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.

Вмешательства

• Поведенческое Centralized patient outreach for lung cancer screening
  Centralized patient outreach for lung cancer screening will be conducted by the lung screening team and will consist of a letter followed by telephone contact. One week following the mail invitation, a senior patient coordinator (SPC) will make telephone contact with individuals to pre-screen eligibility determination based on pack-year smoking history. Up to three telephone contact attempts will be made within two weeks.

Первичные конечные точки

• Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization. [Срок оценки: Within 15 months of randomization]

Вторичные конечные точки (4)

• LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS) [Срок оценки: Within 15 months of randomization]
• LDCT incident findings [Срок оценки: Within 15 months of randomization]
• Follow-up care [Срок оценки: Within 6 months after screening]
• Average costs of implementing centralized outreach per individual [Срок оценки: Within 15 months of randomization]

Критерии участия

Критерии включения

• Adults aged 50 to 80 years
• Current or past smokers
• Individuals without a recorded LDCT scan within the past year
• Individuals without a prior lung cancer diagnosis
• Active patients of Ryan Health
• Individuals with a mailing address in the New York City area and a phone number on file

Критерии исключения

• Individuals aged less than 50 or above 80 years
• Individuals without smoking history
• Individuals with a recorded LDCT scan within the past year
• Individuals with a prior lung cancer diagnosis
• Individuals without a mailing address in the New York City area or a phone number on file
• Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed

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

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT07216144 · 25-04028716

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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