CONNECTing to LungCare
- Conditions
- Smoking CessationCigarette Smoking-Related CarcinomaLung Carcinoma
- Interventions
- Behavioral: Smoking Cessation InterventionOther: Saliva CollectionOther: Survey Administration
- Registration Number
- NCT06213532
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 147
- 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.
- Not a current smoker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Feasibility trial, Group II (usual care) Smoking Cessation Intervention Participants receive usual care from their provider at their primary care appointment. Feasibility trial, Group II (usual care) Saliva Collection Participants receive usual care from their provider at their primary care appointment. Beta testing (CONNECTing to LungCare, feedback) Survey Administration Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement. Feasibility trial, Group I (CONNECTing to LungCare) Smoking Cessation Intervention 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. Feasibility trial, Group I (CONNECTing to LungCare) Saliva Collection 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. Feasibility trial, Group II (usual care) Survey Administration Participants receive usual care from their provider at their primary care appointment. Feasibility trial, Group I (CONNECTing to LungCare) Survey Administration 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. Beta testing (CONNECTing to LungCare, feedback) Smoking Cessation Intervention Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.
- Primary Outcome Measures
Name Time Method Retention rates Up to 1 year The percentage of participants who joined the study and completed the program will be reported.
Adherence rates Up to 1 year The percentage of participants who joined the study and completed all tasks within the program will be reported.
Recruitment rate 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) Up to 1 year The overall time in weeks required to recruit participants for the feasibility cohort will be reported.
Number of eligible participants Up to 1 year The number of eligible participants required to recruit the required sample size will be reported
- Secondary Outcome Measures
Name Time Method Shared decision making about LCS Up to 3 months Evidence of shared decision-making conversation will be obtained through one week follow up phone call and with review of the EHR three months after the primary care physician visit.
Lung cancer screening (LCS) rates Up to 3 months Rates of LCS will be evaluated through review of the electronic health record (EHR)
Smoking cessation rates At 3 months Will evaluate the impact of the intervention on smoking cessation rates. Rates of smoking cessation will be measured by self-report and validated by salivary cotinine levels.
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States