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Идёт набор NCT07585357

Adaptive Mobile Interventions to Reduce Cancer Risk Behaviors

Без фазы С лечением Smoking Cessation

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: Smartphone-based intervention messages.
Кому может быть актуально
Состояния в реестре: Smoking Cessation. Базовые параметры: 18 лет — 40 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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Обзор

Tobacco use remains the leading cause of preventable death, causing over 400,000 annual deaths in the United States alone. Smartphone-based interventions, particularly those leveraging real-time adaptive messaging, represent a promising yet underutilized approach to delivering personalized tobacco and cannabis treatment. The investigator's ongoing NCI funded micro-randomized trial (MRT; R01 CA246590) has shown initial feasibility in reducing smoking urges through situationally tailored cognitive-behavioral therapy (CBT) and mindfulness-based acceptance and commitment-based therapy (ACT) messages triggered by real-time contextual data (e.g., geolocation, momentary stress). To advance from a static MRT framework to a dynamic, data-driven just-in-time adaptive intervention (JITAI), this project aims to develop, test, and refine a reinforcement learning (RL) algorithm that can continuously adapt to user needs in real-time, enhancing treatment outcomes for various tobacco and cannabis products. To ensure optimal usability and engagement, the investigators will conduct user-centered testing with the developed RL-based intervention delivery in one cohort (N=7) over 45 days. This will include usability assessment via the System Usability Scale, analysis of app interaction metrics, and semi-structured interviews to gather feedback for refining message content, timing, and design.

Вмешательства

  • Поведенческое Smartphone-based intervention messages
    Intervention messages will suggest strategies of coping with smoking urges in the moment.

Первичные конечные точки

  • Change in smoking urge as assessed by a single item [Срок оценки: 15 minutes after message delivery]
  • Change in cigarettes smoked per day in past week as assessed by a single item [Срок оценки: Baseline, 45-day follow-up]
  • System Usability as assessed by the System Usability Scale (SUS) [Срок оценки: 45-day follow-up]
Вторичные конечные точки (12)
  • Smoking since intervention message delivery as assessed by a single item [Срок оценки: 15 minutes after message delivery]
  • Other tobacco product use since intervention message delivery as assessed by a single item [Срок оценки: 15 minutes after message delivery]
  • Change in stress as assessed by a single item [Срок оценки: 15 minutes after message delivery]
  • Change in negative affect as assessed by a single item [Срок оценки: 15 minutes after message delivery]
  • Message helpfulness as assessed by a single item [Срок оценки: 15 minutes after message delivery]
  • Activity completion as assessed by a single item [Срок оценки: 15 minutes after message delivery]
  • Self-reported 7-day point prevalence abstinence as assessed by a single item [Срок оценки: 45-day follow-up]
  • Change in cigarettes smoked as assessed by a single item [Срок оценки: Baseline, 45-day follow-up]
  • Tobacco quit attempt as a assessed by a single item [Срок оценки: 45-day follow-up]
  • Change in frequency and intensity of smoking urges as assessed by two items of the Mood and Physical Symptoms Scale (MPSS) [Срок оценки: Baseline, 45-day follow-up]
  • Change in psychological flexibility as assessed by the CompACT-15 [Срок оценки: Baseline, 45-day follow-up]
  • Change in smoking-specific experiential avoidance as assessed by the Avoidance and Inflexibility Scale (AIS) [Срок оценки: Baseline, 45-day follow-up]

Критерии участия

Критерии включения

  • live in the U.S.;
  • are between 18 and 40 years of age;
  • own a smartphone with iOS and Android operating system and GPS capabilities;
  • are carrying smartphone every day;
  • are willing to participate in the study for 44 days and give the research team access to the phone GPS data;
  • have smoked ≥100 cigarettes in the participant's life and currently smoke at least 3 cigarettes per day on 5 or more days of the week;
  • are planning to quit smoking within the next 30 days.

Критерии исключения

  • None

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Johns Hopkins Bloomberg School of Public Health — Baltimore

Идентификаторы

NCT: NCT07585357 · IRB00033759

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗