CONNECTing to LungCare

NCT06213532 | Recruiting

• 2 other identifiers: 226311NCI-2023-10506
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking Cessation; Cigarette Smoking-Related Carcinoma; Lung Carcinoma

Outcome Measures

Primary Outcomes (5)

• Recruitment rate

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

  Up to 1 year

• Retention rates

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

  Up to 1 year

• Adherence rates

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

  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.

  Up to 1 year

• Number of eligible participants

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

  Up to 1 year

Secondary Outcomes (3)

• Smoking cessation rates

  At 3 months

• Lung cancer screening (LCS) rates

  Up to 3 months

• Shared decision making about LCS

  Up to 3 months

Study Arms (3)

Beta testing (CONNECTing to LungCare, feedback)

OTHER

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

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.

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.

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

Interventions

Smoking Cessation Intervention BEHAVIORAL

Multimedia program administered either remotely or in person

Also known as: CONNECTing to LungCare intervention

Beta testing (CONNECTing to LungCare, feedback); Feasibility trial, Group I (CONNECTing to LungCare); Feasibility trial, Group II (usual care)

Saliva Collection OTHER

Saliva samples will be collected from each participant

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

Feasibility trial, Group I (CONNECTing to LungCare); Feasibility trial, Group II (usual care)

Survey Administration OTHER

Ancillary studies

Beta testing (CONNECTing to LungCare, feedback); Feasibility trial, Group I (CONNECTing to LungCare); Feasibility trial, Group II (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not a current smoker

Sponsors & Collaborators

• Tobacco Related Disease Research Program: collaborator
• Alere San Diego: collaborator
• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Lung Neoplasms

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Judith Walsh-Cassidy, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Walsh

CONTACT

(415) 502-0862; lungcare@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: January 19, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)