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Идёт набор NCT06945120

ACT Lung Health Intervention: Phase Two

Без фазы С лечением Smoking Cessation Smoking Behaviors Smoking, Tobacco Smoking, Cigarette

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: ACT Lung Health Intervention.
Кому может быть актуально
Состояния в реестре: Smoking Cessation, Smoking Behaviors, Smoking, Tobacco, Smoking, Cigarette. Базовые параметры: 18 лет — 100 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 →

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Официальное название

Efficacy of an Asian Culture-tailored Lung Health (ACT) Intervention on Lung Cancer Screening and Smoking Cessation in Asian Americans

Обзор

This study aims to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.

Подробное описание

This two-arm stratified randomized clinical trial is to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.

Participants will be randomized into one of two groups: Group A: ACT Lung Health Intervention versus Group B: Standard Care. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, questionnaires, and saliva tests.

It is expected participation in this study will last about 6 months.

About 50 participants are expected to take part in this research study.

The National Cancer Institute is providing funding for this trial.

Вмешательства

  • Поведенческое ACT Lung Health Intervention
    An Asian culture-tailored lung health intervention, which includes individual counseling sessions, family coaching, provision of nicotine replacement therapy (NRT) in the form of patches, lozenges, or chewing gum, and educational materials about low-dose computed tomography (LDCT) for lung cancer screening. The eight weekly, counseling sessions with study staff will be conducted via phone call or the Zoom web-conferencing platform.

Первичные конечные точки

  • Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A) [Срок оценки: 6 months post-baseline assessment]
  • Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B) [Срок оценки: 6 months post-baseline assessment]
Вторичные конечные точки (8)
  • Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A) [Срок оценки: Baseline and 6 months post-baseline assessment]
  • Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B) [Срок оценки: Baseline and 6 months post-baseline assessment]
  • Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A) [Срок оценки: 3 months post-baseline assessment]
  • Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B) [Срок оценки: 3 months post-baseline assessment]
  • Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A) [Срок оценки: 6 months post-baseline assessment]
  • Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B) [Срок оценки: 6 months post-baseline assessment]
  • Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A) [Срок оценки: Within 6 months post-baseline assessment]
  • Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B) [Срок оценки: Within 6 months post-baseline assessment]

Критерии участия

Критерии включения

  • Self-identify as either Chinese or Korean
  • Speak either Korean, Mandarin, or English
  • Are 18 years of age or older
  • Are current smokers (i.e., have smoked at least 100 traditional cigarettes ever and have smoked at least one traditional cigarette within the prior 30 days)
  • Will live in the United States for the next 12 months

Критерии исключения

  • Hospitalization due to a serious mental illness (e.g., psychotic disorders) during the prior 6 months.
  • We will not include any of the following special populations:
  • Adults unable to consent.
  • Adults younger than 50 or older than 80 years
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Организация здравоохранения

Центры проведения

США · 2 центра
  • Dana-Farber Cancer Institute — Boston
  • University of Massachusetts-Boston — Boston

Идентификаторы

NCT: NCT06945120 · 25-041 · 5U54CA156734-14 · 5U54CA156732-14

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗