Evaluating the Impact of CONNECT in a Multilingual Population

Официальное название

Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population

Обзор

This study aims to broaden the reach of the lung cancer screening (LCS) CONNECT program (NCT04149249, NCT06213532), by developing a version of the program to be available to multilingual communities. The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a video doctor with personalized responses, text message and telephone call support and connection with a pharmacist to assist in obtaining nicotine replacement medication. This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current adult smokers within the Spanish and Cantonese speaking communities.

Подробное описание

PRIMARY OBJECTIVES:

I. Culturally adapt, translate, improve and fine tune the multi-faceted CONNECT program for multilingual smokers

II. Evaluate the CONNECT multilingual program for current smokers in multilingual communities.

III. Assess the impact of the CONNECT Multilingual program on smoking cessation rates and participant utilization of evidence-based resources to help quit smoking

OUTLINE:

FOCUS GROUP (N=24):

Three focus groups, one each with English, Spanish and Cantonese speaking participants (8 in each group) will be led by investigators. Interviews will be recorded, transcribed and translated. Translation of the Spanish and Cantonese transcripts will be done by University of California, San Francisco (UCSF) translation services.

BETA GROUP (N=15):

The investigators will conduct a pilot, beta testing of the intervention materials with English, Spanish and Cantonese speaking participants. Additional feedback and input from the participants will be used to fine tune the CONNECT smoking cessation intervention to be implemented in a randomized trial.

RANDOMIZED CONTROLLED TRIAL (N=400):

Newly enrolled participants will be assigned to 1 of 2 conditions.

* Group 1: Participants receive the CONNECT Multilingual intervention. Participants will be followed up at 1-week, 1-, 3-, and 6-months after treatment assignment. At 6-months, participants will be asked to complete and return an at-home saliva kit to verify their smoking status. * Group 2: Participants receive usual care from providers at a regular primary care appointment. Participants will be followed up at 1-week, 1-, 3-, and 6-months after treatment assignment.

Вмешательства

• Поведенческое CONNECT Intervention for multilingual populations
  The program includes interactive Video Doctor visits to provide participants with information tailored to their individual responses and outreach via brief telephone calls and text messaging to follow-up and connect smokers with evidence-based resources for smoking cessation.
• Другое Saliva Sample
  Undergo saliva collection
• Другое Interview
  Attend a focus group

Первичные конечные точки

• Percentage of participants Smoking cessation rates (Randomized groups only) [Срок оценки: Up to 6 months]
• Mean number of quit attempts over time (Randomized groups only) [Срок оценки: Up to 6 months]
• Percentage of participants who reported use of smoking cessation resources (Randomized groups only) [Срок оценки: Up to 6 months]

Вторичные конечные точки (2)

• Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only) [Срок оценки: Up to 6 months]
• Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only) [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• Age 50-80 years old.
• Current smokers defined at smoking at least one cigarette in past 7 days AND eligible for lung cancer screening (LCS) based on smoking history (>=20 pack year history)
• California (CA) residents
• Able to understand and comply with study procedures for the entire length of the study.
• Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.

Критерии исключения

• Non-smokers.
• Individuals with a diagnosis of lung cancer.
• Individuals receiving hospice care.
• Individuals whose providers do not think that they should participate (e.g., psychiatric illness or significant cognitive impairment that would impede the individuals ability to participate).
• Hearing and/or vision disabilities that would prevent participants from adequately receiving treatment components such as video or telephone counseling.

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: NCT07111936 · 25635 · NCI-2025-05153

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗