Clinical trial NCT06213532: CONNECTing to LungCare
Official title: CONNECTing to LungCare
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Cigarette Smoking-Related Carcinoma
Lung Carcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
name: Alere San Diego
First posted: 2024-01-19
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Up to 1 year
measure: Retention rates
timeFrame: Up to 1 year
measure: Adherence rates
timeFrame: Up to 1 year
measure: Overall time required to recruit to the target sample size (Feasibility Cohort)
timeFrame: Up to 1 year
measure: Number of eligible participants
timeFrame: Up to 1 year
Secondary outcomes:
measure: Smoking cessation rates
timeFrame: At 3 months
measure: Lung cancer screening (LCS) rates
timeFrame: Up to 3 months
measure: Shared decision making about LCS
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith Walsh-Cassidy, MD
role: PRINCIPAL_INVESTIGATOR
References: