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Идёт набор NCT06898333

Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening

— Наблюдательное Lung Cancer Cancer of the Lung

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Lung Cancer, Cancer of the Lung. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Evaluating the Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening

Обзор

The investigators proposal is ripe for executing as the investigators seek to leverage this "natural experiment" initiated by the BJC health system to evaluate the effectiveness of the Pink \& Pearl Campaign as an implementation strategy to promote lung cancer screening (LCS) uptake among LCS-eligible women undergoing mammography at BJC West County. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, the research questions and specific aims for this proposal are to: a) evaluate the baseline prevalence of LCS among LCS-eligible women; b) assess whether the Pink \& Pearl Campaign increases referrals and uptake/ completion of LCS among LCS-eligible women undergoing screening mammography; and c) evaluate individual and environmental factors influencing LCS uptake, and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS.

Первичные конечные точки

  • Prevalence of LCS-eligible women who opt-in to, and successfully, complete LCS mammography and opt-in to lung cancer screening [Срок оценки: At baseline]
  • Number of women screened for LCS [Срок оценки: At 3 months]
  • Number of women screened for LCS [Срок оценки: At 6 months]
  • Feasibility of Pink and Pearl project [Срок оценки: At 6 months]
  • Acceptability of Pink and Pearl project [Срок оценки: At 6 months]
  • Appropriateness of Pink and Pearl project [Срок оценки: At 6 months]
Вторичные конечные точки (9)
  • Median time to lung cancer screening [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • Number of women who have a positive lung radiology screening [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • Rate of follow-up for a positive screening examination [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • False positive rates [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • Invasive intervention rate [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • Cancer yield rate [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • Adverse event rate for screening [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • Number of women with varying Stage (1-4) findings in the lung screening radiology report. [Срок оценки: Through completion of follow-up (estimated to be 1 year)]
  • Cause of death [Срок оценки: Through completion of follow-up (estimated to be 1 year)]

Критерии участия

Inclusion Criteria for Participants:

  • Undergoing screening mammography
  • Between the ages of 50-80 years (inclusive)
  • Reporting a 20 pack-year equivalent of either current smoking history or have quit in the past 15 years
  • Can speak and understand English
  • Ability to understand willingness to provide informed consent.

Exclusion Criteria for Participants:

  • Diagnosed with a serious health problem that will likely limit life expectancy (such as previous history of lung cancer, symptoms of lung cancer such as hemoptysis or unexplained weight loss of more than 6.8 kg (15 lb) in the previous year)
  • Subjects with symptoms of lung cancer should get a diagnostic CT scan
  • Unable or unwilling to get treatment if lung cancer is found

Eligibility Criteria for Providers:

  • Older than 20 years of age

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • Barnes-Jewish Hospital West County — Creve Coeur

Идентификаторы

NCT: NCT06898333 · 202412064

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗