CClinicalTrials.gg
Active, not recruitingNCT06213532Updated Oct 5, 2026

CONNECTing to LungCare

An interventional study of Smoking Cessation Intervention and Saliva Collection in Smoking Cessation, Cigarette Smoking-Related Carcinoma and Lung Carcinoma, sponsored by University of California, San Francisco. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention

Updated Oct 5, 2026Now Active, not recruitingEnrollment updatedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Smoking Cessation
  • Cigarette Smoking-Related Carcinoma
  • Lung Carcinoma
03

In context

Smoking Cessation

304 studies on the registry are indexed under Smoking Cessation; 139 are open to participants now.

This study's enrollment of 53 is below the median of 153 across 285 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Not a current smoker
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Other
    Beta testing (CONNECTing to LungCare, feedback)

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

    Behavioral: Smoking Cessation Intervention · Other: Survey Administration

  • Experimental
    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.

    Behavioral: Smoking Cessation Intervention · Other: Saliva Collection · Other: Survey Administration

  • Active comparator
    Feasibility trial, Group II (usual care)

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

    Behavioral: Smoking Cessation Intervention · Other: Saliva Collection · Other: Survey Administration

Interventions

  • BehavioralSmoking Cessation Intervention

    Multimedia program administered either remotely or in person

    Also known as: CONNECTing to LungCare intervention

  • OtherSaliva Collection

    Saliva samples will be collected from each participant

    Also known as: Biospecimen Collection, Specimen Sample, Saliva Sample

  • OtherSurvey Administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. Recruitment rate

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

    Time frame: Up to 1 year

  2. Retention rates

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

    Time frame: Up to 1 year

  3. Adherence rates

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

    Time frame: Up to 1 year

  4. 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.

    Time frame: Up to 1 year

  5. Number of eligible participants

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

    Time frame: Up to 1 year

Secondary outcomes

  1. 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.

    Time frame: At 3 months

  2. Lung cancer screening (LCS) rates

    Rates of LCS will be evaluated through review of the electronic health record (EHR)

    Time frame: Up to 3 months

  3. 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.

    Time frame: Up to 3 months

07

Study locations

1 site
  • University of California, San Francisco
    San Francisco, California 94143, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Oct 5, 2026
Enrollment
152 (estimated)→53 (actual)
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Recruiting→Active, not recruiting
    Enrollment 152 (estimated)→53 (actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06213532
Lead sponsor
University of California, San Francisco
Collaborators
Tobacco Related Disease Research Program, Alere San Diego
Responsible party
Sponsor
First posted
Jan 19, 2024
Start date
Dec 3, 2024
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Oct 5, 2026

Study contacts

Judith Walsh-Cassidy, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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