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Trial Title:
CONNECTing to LungCare
NCT ID:
NCT06213532
Condition:
Smoking Cessation
Cigarette Smoking-Related Carcinoma
Lung Carcinoma
Conditions: Official terms:
Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Smoking Cessation Intervention
Description:
Multimedia program administered either remotely or in person
Arm group label:
Beta testing (CONNECTing to LungCare, feedback)
Arm group label:
Feasibility trial, Group I (CONNECTing to LungCare)
Arm group label:
Feasibility trial, Group II (usual care)
Other name:
CONNECTing to LungCare intervention
Intervention type:
Other
Intervention name:
Saliva Collection
Description:
Saliva samples will be collected from each participant
Arm group label:
Feasibility trial, Group I (CONNECTing to LungCare)
Arm group label:
Feasibility trial, Group II (usual care)
Other name:
Biospecimen Collection
Other name:
Specimen Sample
Other name:
Saliva Sample
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Beta testing (CONNECTing to LungCare, feedback)
Arm group label:
Feasibility trial, Group I (CONNECTing to LungCare)
Arm group label:
Feasibility trial, Group II (usual care)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Contact:
Last name:
Van Le
Phone:
877-827-3222
Email:
Van.Le@ucsf.edu
Contact backup:
Email:
cancertrials@ucsf.edu
Investigator:
Last name:
Judith Walsh-Cassidy, MD
Email:
Principal Investigator
Start date:
June 30, 2024
Completion date:
June 30, 2025
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Tobacco Related Disease Research Program
Agency class:
Other
Collaborator:
Agency:
Alere San Diego
Agency class:
Industry
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06213532
