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Набор по приглашению NCT07716527

Pilot Testing a Web-based Prototype of a Lung Cancer Screening Digital Health Tool

Без фазы С лечением Lung Cancer Screening

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
В протоколе указаны: Digital health tool prototype, Control Arm - standard of care.
Кому может быть актуально
Состояния в реестре: Lung Cancer Screening. Базовые параметры: 50 лет — 80 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

The purpose of this study is to evaluate the acceptability, usability, and preliminary efficacy of a web-based prototype of a digital health tool for lung cancer screening (LCS). The digital health tool is designed to support high quality decision-making for individuals potentially eligible for lung cancer screening. Researchers will compare the intervention arm (who will use the digital health tool prototype) with the control arm (who will read a 2-page publicly available information sheet about lung cancer screening from American Cancer Society).

Подробное описание

Lung cancer is the leading cause of cancer death in the US. In 2011, the landmark National Lung Screening Trial demonstrated that LCS using low-dose computed tomography (LDCT) can reduce lung cancer mortality by 20%, compared to chest X-rays, after annual screenings. Hence, the United States Preventive Services Task Force (USPSTF) recommends LCS for individuals age 50-80, who currently smoke or quit smoking within the past 15 years, and who have at least a 20 pack-year smoking history. The USPSTF gave LCS a Grade B recommendation, indicating that there is high certainty that the benefits of LCS outweigh the risks for this population. Despite the well-documented benefits of LCS and USPSTF's Grade B recommendation, LCS uptake remains very low at only 18%. In contrast, breast and colon cancer screening rates exceed 70%, even though their combined annual deaths are ¾ that of lung cancer. As LCS has both potential benefits and harms (e.g., false positives, small amounts of radiation exposure, potential invasive diagnostic testing), USPSTF also recommends that all patients undergo shared decision-making (SDM) prior to initial screening. Furthermore, the Centers for Medicare \& Medicaid Services (CMS) mandates an SDM conversation using a decision aid prior to initial screening. Yet, SDM is not routinely performed and patients are rarely informed about potential harms in routine practice. Hence, interventions aiming to improve LCS uptake and decision quality among high-risk populations are urgently needed to realize the mortality benefit of LCS.

To address these gaps, the investigators will develop a digital health tool, which is an interactive website that delivers high-quality, standardized SDM and psychoeducation about LCS to patients. This study's aims are to: 1) evaluate acceptability of the digital health tool prototype among people with a smoking history; 2) assess changes in cognitive outcomes before and after exposure to the digital health tool and across comparison groups; and 3) assess the digital health tool's impact on LCS intentions.

The digital health tool includes a home page and 7 modules: 1) a video decision aid about LCS; 2) video of the LDCT procedure; 3) lung cancer risk calculator and individualized lung cancer risk scores for patients; 4) patient testimonials; 5) frequently asked questions (e.g., costs associated with LDCT); 6) patient's decision; and 7) resources for smoking cessation.

For this pilot study, the investigators will be utilizing a quantitative approach using surveys. This study will use a randomized pre-post design to assess the impact of exposure to the digital health tool prototype. Participants (N=500) will be randomized to view either the digital health tool prototype or standard education materials about LCS in a 1:1 ratio. Participants will be contacted 3 months after the initial survey to complete a brief follow-up survey assessing LCS behavior.

Participants will be recruited through Qualtrics Research Panels. Potential participants will complete a screening form to confirm their eligibility. The inclusion criteria are: 1) age 50-80; and 2) currently smoke or quit smoking within the past 15 years. If they are eligible, potential participants will be directed to an informed consent form where they will be asked to indicate their agreement to participate in this study. Participants who agree to participate will then complete a pre-survey, use either the digital health tool prototype or standard education materials, and then complete a post-survey. 3 months after the initial survey, participants will be contacted again to complete a follow-up survey.

Вмешательства

  • Поведенческое Digital health tool prototype
    Intervention participants will view a web-based interactive prototype of the digital health tool. The digital health tool contains information about lung cancer screening, the screening procedures, a personalized lung cancer risk calculator, patient stories, frequently asked questions, and smoking cessation resources.
  • Поведенческое Control Arm - standard of care
    The control arm will read a 2-page educational material about lung cancer screening publicly available from American Cancer Society.

Первичные конечные точки

  • Self- reported receipt of Lung Cancer Screening [Срок оценки: 3 months]
Вторичные конечные точки (10)
  • Lung Cancer Screening Intention [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Stage of Decision Making [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Ottowa Acceptability Measure [Срок оценки: Immediately post-intervention (within 24 hours)]
  • System Usability Scale (SUS) [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Knowledge of LCS [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Perceived risk [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Perceived benefits [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Perceived barriers [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Decisional Conflict (SURE) [Срок оценки: Immediately post-intervention (within 24 hours)]
  • Preparation for Decision Making [Срок оценки: Immediately post-intervention (within 24 hours)]

Критерии участия

Критерии включения

  • Age 50-80 years
  • Currently smoke or have quit smoking within the past 15 years
  • English-speaking

Критерии исключения

  • Younger than 50 years or older than 80 years
  • Never smoked or quit smoking more than 50 years ago
  • Non-English-speaking

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
Профилактика

Центры проведения

США · 1 центр
  • Rutgers Cancer Institute of New Jersey — New Brunswick

Идентификаторы

NCT: NCT07716527 · Pro2026000388

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗