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Идёт набор NCT06098144

Smoking Cessation Program in the Construction Sector

Фаза IV С лечением Smoking Cessation Tobacco Use Cessation Tobacco Smoking

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: Nicorette, Tobacco Quit-line, Brief Behavioral Counseling, Intensive Behavioral Counseling.
Кому может быть актуально
Состояния в реестре: Smoking Cessation, Tobacco Use Cessation, Tobacco Smoking. 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

Expanding the Role of the Safety Manager to Implement a Workplace Smoking Cessation Program in the Construction Sector

Обзор

The main objective of this study is to identify the optimal adaptive smoking cessation program for the construction sector in terms of effectiveness, cost-effectiveness, and potential implementation.

Вмешательства

  • Препарат Nicorette
    Participants will receive a 6-week supply of nicotine replacement treatment (NRT). Based on participants' self-report on the number of cigarettes smoked, these are the possible dosages of NRT gum (2 mg and 4 mg). Participants should not smoke and use the nicotine gum at the same time. Nicotine gum should only be used when cravings for cigarettes arise and should not be treated like regular chewing gum. It is not to be constantly chewed NRT will be distributed based on the treatment condition.
  • Поведенческое Tobacco Quit-line
    The TQL is free, and the TQL counselor will provide three phone counseling sessions lasting approximately 15 minutes to devise a specific plan to quit smoking and arrange the delivery of 4 to 12 weeks of NRT based on need. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances.
  • Поведенческое Brief Behavioral Counseling
    The counseling session will discuss preparing to quit, coping with job-related stress, getting social support, the "5A's" for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), proper use of NRT, and last approximately 30 minutes.
  • Поведенческое Intensive Behavioral Counseling
    Participants will receive four weekly counseling sessions which include information about how to quit, challenges, and short and long-term relapse prevention. Each session will last approximately 20 minutes.

Первичные конечные точки

  • Program Effectiveness Measure in Percentage [Срок оценки: Up to 4 years]
  • Program Cost-Effectiveness Measured by Number of U.S Dollars [Срок оценки: Up to 4 years]
  • Program Cost-Effectiveness Measured by Quality Adjusted Life Years [Срок оценки: Up to 4 years]
Вторичные конечные точки (3)
  • Program's Implementation- Acceptability Measured by Likert Scale [Срок оценки: Up to 4 years]
  • Program's Implementation- Feasibility Measured by Likert Scale [Срок оценки: Up to 4 years]
  • Program's Implementation- Sustainability Measured by Likert Scale [Срок оценки: Up to 4 years]

Критерии участия

Критерии включения

Company leaders:

  • ≥ 18 years
  • Involved in decision making
  • Willing to participate in the implementation development and evaluation

Safety Managers:

\- ≥ 18 years Self-identified as a safety manager or superintendent Have no plans to leave the company in the next year Speak either English or Spanish Non-cigarette smoker Willing to receive training in smoking cessation treatment Willing to deliver the smoking cessation treatment to workers

Construction Workers:

  • Be a construction worker
  • ≥ 18 years
  • Have smoked on average 5 or more cigarettes daily for the past year
  • Willing to make a serious quit attempt in the next 30 days
  • Willing to receive treatment from the Florida Tobacco Quitline.
  • Planning to stay in the company for the next 6 months
  • Own a telephone and plan to keep it active for the next 12 months

Критерии исключения

Safety Managers:

\- Current cigarette smoker

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
Лечение

Центры проведения

США · 1 центр
  • Don Soffer Clinical Research Center — Miami

Публикации

  • Asfar T, Lee DJ, Salloum RG, LeLaurin JH, Kobetz E, Pradhananga N, De Dios Despaux RA, McCollister KE, Oluwole O, Corbin L, Laine J, Bursac Z. Empowering safety managers to champion the implementation of smoking cessation services in the construction industry: Protocol for a sequential multiple assignment randomized trial. PLoS One. 2025 Jun 9;20(6):e0324717. doi: 10.1371/journal.pone.0324717. eCo PMID 40489501

Идентификаторы

NCT: NCT06098144 · 20230549

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗