| Registry | NCT06213532 |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, sequential, masking: none, prevention |
| Enrollment | 53 (Actual) |
| Sponsor | University of California, San Francisco (Other); collaborators: Tobacco Related Disease Research Program, Alere San Diego |
| Conditions | Smoking Cessation, Cigarette Smoking-Related Carcinoma, Lung Carcinoma |
| Interventions | Smoking Cessation Intervention, Saliva Collection, Survey Administration (Behavioral, other) |
| Dates | start 2024-12-03, primary completion 2026-11-30 (estimated), completion 2026-11-30 (estimated), first posted 2024-01-19, last updated 2026-10-05 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Smoking Cessation All trials for Cigarette Smoking-Related Carcinoma All trials of Smoking Cessation Intervention All trials of Saliva Collection
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Beta testing (CONNECTing to LungCare, feedback) | Other | Behavioral: Smoking Cessation Intervention; Other: 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) | Experimental | Behavioral: Smoking Cessation Intervention; Other: Saliva Collection; Other: 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. |
| Feasibility trial, Group II (usual care) | Active comparator | Behavioral: Smoking Cessation Intervention; Other: Saliva Collection; Other: Survey Administration | Participants receive usual care from their provider at their primary care appointment. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
Inclusion Criteria: * 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. Exclusion Criteria: * Not a current smoker
| Facility | City | Country | Status |
|---|---|---|---|
| University of California, San Francisco | San Francisco, California | United States |