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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation; Lung Carcinoma; Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Behavioral: Smoking Cessation Intervention; Other: Saliva Collection

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.

• Study Type: Interventional
• Enrollment (Estimated): 147
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Van Le; Phone Number: 877-827-3222; Email: Van.Le@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
      • Contact: Email: cancertrials@ucsf.edu
      • Contact: Van Le; Phone Number: 877-827-3222; Email: Van.Le@ucsf.edu
      • Principal Investigator: Judith Walsh-Cassidy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Beta testing (CONNECTing to LungCare, feedback); Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.	Other: Survey Administration; Ancillary studies; Behavioral: Smoking Cessation Intervention; Multimedia program administered either remotely or in person; Other Names: CONNECTing to LungCare intervention
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.	Other: Survey Administration; Ancillary studies; Behavioral: Smoking Cessation Intervention; Multimedia program administered either remotely or in person; Other Names: CONNECTing to LungCare intervention; Other: Saliva Collection; Saliva samples will be collected from each participant; Other Names: Biospecimen Collection; Specimen Sample; Saliva Sample
Active Comparator: Feasibility trial, Group II (usual care); Participants receive usual care from their provider at their primary care appointment.	Other: Survey Administration; Ancillary studies; Behavioral: Smoking Cessation Intervention; Multimedia program administered either remotely or in person; Other Names: CONNECTing to LungCare intervention; Other: Saliva Collection; Saliva samples will be collected from each participant; Other Names: Biospecimen Collection; Specimen Sample; Saliva Sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 3 months
Lung cancer screening (LCS) rates	Rates of LCS will be evaluated through review of the electronic health record (EHR)	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.	Up to 3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Tobacco Related Disease Research Program; Alere San Diego
• Investigators: Principal Investigator: Judith Walsh-Cassidy, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 9, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 226311; NCI-2023-10506 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No