Smoking CessationNCT06213532
CONNECTing to LungCare
A study testing Smoking Cessation Intervention, Saliva Collection and Survey Administration in people with Smoking Cessation and Cigarette Smoking-Related Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Cigarette Smoking-Related Carcinoma, Lung Carcinoma
- What is being tested?
- Smoking Cessation Intervention, Saliva Collection and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2024to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not a current smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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.
- Being tested
- Smoking Cessation Intervention, Saliva Collection, Survey Administration
- Medical subject headings
- Smoking Cessation, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation InterventionBehavioural
Also called CONNECTing to LungCare intervention
Multimedia program administered either remotely or in person
Saliva CollectionOther
Also called Biospecimen Collection, Specimen Sample, Saliva Sample
Saliva samples will be collected from each participant
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Beta testing (CONNECTing to LungCare, feedback) | Other | Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement. Receives: Behavioral: Smoking Cessation Intervention; Other: Survey Administration |
| Feasibility trial, Group I (CONNECTing to LungCare) | Experimental | 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. Receives: Behavioral: Smoking Cessation Intervention; Other: Saliva Collection; Other: Survey Administration |
| Feasibility trial, Group II (usual care) | Active comparator | Participants receive usual care from their provider at their primary care appointment. Receives: Behavioral: Smoking Cessation Intervention; Other: Saliva Collection; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The percentage of participants who were contacted and joined the study will be reported.
Measured: Up to 1 year
Retention rates
The percentage of participants who joined the study and completed the program will be reported.
Measured: Up to 1 year
Adherence rates
The percentage of participants who joined the study and completed all tasks within the program will be reported.
Measured: Up to 1 year
Overall time required to recruit to the target sample size (Feasibility Cohort)
The overall time in weeks required to recruit participants for the feasibility cohort will be reported.
Measured: Up to 1 year
Number of eligible participants
The number of eligible participants required to recruit the required sample size will be reported
Measured: Up to 1 year
Secondary outcomes (3)
Smoking cessation rates
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.
Measured: At 3 months
Lung cancer screening (LCS) rates
Rates of LCS will be evaluated through review of the electronic health record (EHR)
Measured: Up to 3 months
Shared decision making about LCS
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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start3 Dec 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The first cohort of participants will be enrolled on the Beta Arm or intervention development. Once developed, new participants will be randomized into Groups 1 and Groups 2.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Tobacco Related Disease Research Program, Alere San Diego
- Responsible party
- Sponsor
- Investigators
- Judith Walsh-Cassidy, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213532
- Sponsor's protocol ID
- 226311
- Other IDs
- NCI-2023-10506
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No