CONNECTing to LungCare
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smoking Cessation Intervention, Saliva Collection, Survey Administration.
- Who it may be relevant to
- Registry conditions: Smoking Cessation, Cigarette Smoking-Related Carcinoma, Lung Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Smoking Cessation Intervention
Multimedia program administered either remotely or in person - Other Saliva Collection
Saliva samples will be collected from each participant - Other Survey Administration
Ancillary studies
Primary outcome measures
- Recruitment rate [Time frame: Up to 1 year]
- Retention rates [Time frame: Up to 1 year]
- Adherence rates [Time frame: Up to 1 year]
- Overall time required to recruit to the target sample size (Feasibility Cohort) [Time frame: Up to 1 year]
- Number of eligible participants [Time frame: Up to 1 year]
Secondary outcome measures (3)
- Smoking cessation rates [Time frame: At 3 months]
- Lung cancer screening (LCS) rates [Time frame: Up to 3 months]
- Shared decision making about LCS [Time frame: Up to 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06213532 · 226311 · NCI-2023-10506