Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 439
- 试验地点
- 1
- 主要终点
- Percentage of participants Smoking cessation rates (Randomized groups only)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Focus Group
Participants in the focus group will be interviewed by the study staff and discuss barriers and facilitators to smoking cessation to be implemented in the beta and randomized phases of the study.
干预措施: Interview (Other)
Group 1: CONNECT Multi-lingual intervention
Participants receive the CONNECT multilingual smoking cessation intervention finalized in the beta group analysis, that includes multi-lingual interactive video doctor intervention, text messages once weekly for 12 weeks, and several telephone counseling calls. Participants also receive access to a pharmacist to receive counseling about quitting smoking and may prescribe nicotine replacement therapy. Participants will be asked to provide a saliva sample at the end of the study
干预措施: CONNECT Intervention for multilingual populations (Behavioral)
Group 2: Control Group
Participants will receive usual care for smoking cessation at routine medical visit and be asked to complete a total of four brief follow-up phone surveys. Participants will be asked to provide a saliva sample at the end of the study.
干预措施: Saliva Sample (Other)
Beta Group
Participants will be testing the CONNECT multilingual smoking cessation materials and provide feedback to investigators. Participation will be limited to about 1.5 - 2 hours.
干预措施: CONNECT Intervention for multilingual populations (Behavioral)
Group 1: CONNECT Multi-lingual intervention
Participants receive the CONNECT multilingual smoking cessation intervention finalized in the beta group analysis, that includes multi-lingual interactive video doctor intervention, text messages once weekly for 12 weeks, and several telephone counseling calls. Participants also receive access to a pharmacist to receive counseling about quitting smoking and may prescribe nicotine replacement therapy. Participants will be asked to provide a saliva sample at the end of the study
干预措施: Saliva Sample (Other)
结局指标
主要结局
Percentage of participants Smoking cessation rates (Randomized groups only)
时间窗: Up to 6 months
The rate of smoking cessation will be defined as the percentage of participants who are abstinent from smoking through self-report and biochemical verification using salivary cotinine levels obtained at 6 months after lung cancer screening
Mean number of quit attempts over time (Randomized groups only)
时间窗: Up to 6 months
The number of self-reported 7-day quit attempts over time since lung cancer screening (LCS) will be recorded. Mean and standard deviation will be reported.
Percentage of participants who reported use of smoking cessation resources (Randomized groups only)
时间窗: Up to 6 months
Self-reported use of evidence-based smoking cessation resources (enabling factors) after the lung cancer screening (for example, pharmacotherapy for smoking cessation, calling the California Smokers Helpline, group or individual counseling from healthcare providers, etc.) will be reported as a percentage of all participants by arm.
次要结局
- Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only)(Up to 6 months)
- Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only)(Up to 6 months)