跳至主要内容
临床试验/NCT06213532
NCT06213532
招募中
不适用

CONNECTing to LungCare

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 147 人2024年12月3日

概览

阶段
不适用
干预措施
Saliva Collection
疾病 / 适应症
Smoking Cessation
发起方
University of California, San Francisco
入组人数
147
试验地点
1
主要终点
Retention rates
状态
招募中
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2024年12月3日
结束日期
2026年11月30日
最后更新
上个月
研究类型
Interventional
研究设计
Sequential
性别
All

研究者

入排标准

入选标准

  • 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.

排除标准

  • Not a current smoker

研究组 & 干预措施

Feasibility trial, Group II (usual care)

Participants receive usual care from their provider at their primary care appointment.

干预措施: Saliva Collection

Feasibility trial, Group II (usual care)

Participants receive usual care from their provider at their primary care appointment.

干预措施: Survey Administration

Feasibility trial, Group I (CONNECTing to LungCare)

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.

干预措施: Survey Administration

Feasibility trial, Group II (usual care)

Participants receive usual care from their provider at their primary care appointment.

干预措施: Smoking Cessation Intervention

Beta testing (CONNECTing to LungCare, feedback)

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

干预措施: Smoking Cessation Intervention

Beta testing (CONNECTing to LungCare, feedback)

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

干预措施: Survey Administration

Feasibility trial, Group I (CONNECTing to LungCare)

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.

干预措施: Smoking Cessation Intervention

Feasibility trial, Group I (CONNECTing to LungCare)

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.

干预措施: Saliva Collection

结局指标

主要结局

Retention rates

时间窗: Up to 1 year

The percentage of participants who joined the study and completed the program will be reported.

Adherence rates

时间窗: Up to 1 year

The percentage of participants who joined the study and completed all tasks within the program will be reported.

Recruitment rate

时间窗: Up to 1 year

The percentage of participants who were contacted and joined the study will be reported.

Overall time required to recruit to the target sample size (Feasibility Cohort)

时间窗: Up to 1 year

The overall time in weeks required to recruit participants for the feasibility cohort will be reported.

Number of eligible participants

时间窗: Up to 1 year

The number of eligible participants required to recruit the required sample size will be reported

次要结局

  • Shared decision making about LCS(Up to 3 months)
  • Lung cancer screening (LCS) rates(Up to 3 months)
  • Smoking cessation rates(At 3 months)

研究点 (1)

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