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Идёт набор NCT06213532

CONNECTing to LungCare

Без фазы С лечением Smoking Cessation Cigarette Smoking-Related Carcinoma Lung Carcinoma

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: Smoking Cessation Intervention, Saliva Collection, Survey Administration.
Кому может быть актуально
Состояния в реестре: Smoking Cessation, Cigarette Smoking-Related Carcinoma, Lung Carcinoma. 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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Обзор

This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation and lung cancer screening between patients and providers. Shared decision making is a patient care model in which providers offer information regarding risks and benefits, patients express their values and preferences, and then healthcare decisions are jointly discussed between the patient and provider. Patient education, aided by decision support tools, can increase patients' knowledge, decrease their decisional conflict, promote decision making, and improve the patients' perception of risk. CONNECTing to LungCare is an interactive education intervention that addresses lung cancer screening and smoking cessation and provides participants with a tailored summary that may make them more likely to have shared decision-making discussions with their providers about smoking cessation and lung cancer screening.

Подробное описание

PRIMARY OBJECTIVES:

Aim 1: Development of the smoking cessation and LCS intervention, CONNECTing to LungCare.

Aim 2: Test CONNECTing to Lung Care for Feasibility and Acceptability (N=120)

Aim 3: To qualitatively evaluate feasibility and acceptability of the intervention and study procedures from the perspectives of patients, providers, staff and administrators and other stakeholders.

OUTLINE:

BETA TESTING: Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.

FEASIBILITY TRIAL: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the CONNECTing to LungCare intervention, including education about the benefits and risks of LCS and the importance of shared decision making, computerized assessments of the participant's smoking status, readiness to quit and concerns about quitting, and video segments tailored to the participant's responses to assessment questions, prior to their primary care appointment. Participants and their providers receive a tailored summary of the participant's concerns and barriers to quitting to enhance motivation for smoking cessation and shared decision making discussions. Participants then receive up to 3 follow-up phone calls over 10-15 minutes each encouraging them to follow up with their provider, to complete the shared decision-making conversation, obtain LCS if appropriate, and access smoking cessation resources. Participants may also receive brief, tailored follow-up text messages that include links to video segments or cessation resources 1-3 times weekly.

GROUP II: Participants receive usual care from their provider at their primary care appointment.

After completion of study intervention, participants are followed up at 1 and 3 months.

Вмешательства

  • Поведенческое Smoking Cessation Intervention
    Multimedia program administered either remotely or in person
  • Другое Saliva Collection
    Saliva samples will be collected from each participant
  • Другое Survey Administration
    Ancillary studies

Первичные конечные точки

  • Recruitment rate [Срок оценки: Up to 1 year]
  • Retention rates [Срок оценки: Up to 1 year]
  • Adherence rates [Срок оценки: Up to 1 year]
  • Overall time required to recruit to the target sample size (Feasibility Cohort) [Срок оценки: Up to 1 year]
  • Number of eligible participants [Срок оценки: Up to 1 year]
Вторичные конечные точки (3)
  • Smoking cessation rates [Срок оценки: At 3 months]
  • Lung cancer screening (LCS) rates [Срок оценки: Up to 3 months]
  • Shared decision making about LCS [Срок оценки: Up to 3 months]

Критерии участия

Критерии включения

  • English, Spanish and Cantonese speaking
  • Age >= 18 years old
  • Primary care patients at the University of California, San Francisco (UCSF) General Internal Medicine (GIM) clinics
  • Must be current smokers and/or candidates for Lung Cancer Screening (LCS).

Key Informant Interviews:

\- Must be working in one of the clinics participating in CONNECTing to LungCare.

Критерии исключения

  • Not a current smoker

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06213532 · 226311 · NCI-2023-10506

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗