CONNECTing to LungCare

Smoking Cessation Clinical Trial

Official title:

CONNECTing to LungCare

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06213532
• Other study ID #: 226311
• Secondary ID: NCI-2023-10506
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: University of California, San Francisco
• Contact: Van Le
• Phone: 877-827-3222
• Email: Van.Le[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 147
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Smoking Cessation Intervention
Multimedia program administered either remotely or in person

Other:
• Saliva Collection
Saliva samples will be collected from each participant
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Alere San Diego, Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	The percentage of participants who were contacted and joined the study will be reported.	Up to 1 year
Primary	Retention rates	The percentage of participants who joined the study and completed the program will be reported.	Up to 1 year
Primary	Adherence rates	The percentage of participants who joined the study and completed all tasks within the program will be reported.	Up to 1 year
Primary	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
Primary	Number of eligible participants	The number of eligible participants required to recruit the required sample size will be reported	Up to 1 year
Secondary	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
Secondary	Lung cancer screening (LCS) rates	Rates of LCS will be evaluated through review of the electronic health record (EHR)	Up to 3 months
Secondary	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