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NCT Number: NCT06213532

CONNECTing to LungCare

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.

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Key information

Conditions

Smoking Cessation Behavior Cigarette Smoking-Related Carcinoma Health Behavior Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smoking Cessation Intervention

Behavioral

Multimedia program administered either remotely or in person

Other names: CONNECTing to LungCare intervention

Saliva Collection

Other

Saliva samples will be collected from each participant

Other names: Biospecimen Collection, Specimen Sample, Saliva Sample

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Recruitment rate

    Time frame: Up to 1 year

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

  2. Retention rates

    Time frame: Up to 1 year

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

  3. Adherence rates

    Time frame: Up to 1 year

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

  4. Overall time required to recruit to the target sample size (Feasibility Cohort)

    Time frame: Up to 1 year

    The overall time in weeks required to recruit participants for the feasibility cohort will be reported.

  5. Number of eligible participants

    Time frame: Up to 1 year

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

Secondary outcomes

  1. Smoking cessation rates

    Time frame: 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.

  2. Lung cancer screening (LCS) rates

    Time frame: Up to 3 months

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

  3. Shared decision making about LCS

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Judith Walsh

CONTACT

[email protected]

(415) 502-0862

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Alere San Diego
  • Tobacco Related Disease Research Program

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 19, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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