Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Smoking Cessation
- Sponsor
- Yale University
- Enrollment
- 276
- Locations
- 2
- Primary Endpoint
- Smoking Cessation
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to test the efficacy of two separate, sequential interventions to promote tobacco cessation/reduction in patients who are screened for lung cancer or are eligible for lung cancer screening. Each intervention will be compared to standard of care. The first intervention will be a personalized message intervention, the second intervention will consist of a biofeedback-based intervention.
Detailed Description
The primary aims of this study are to test the efficacy two types of smoking cessation methods (compared to standard care). The aim of the first intervention is to evaluate the efficacy of a personalized message intervention in improving tobacco quit rates above and beyond standard care smoking cessation treatment in patients at risk for lung cancer. Messages will be designed specifically for patients at risk for lung cancer, personalized and presented in a gain-framed manner, taking into account demographics and smoking history. The aim of the second intervention is to evaluate the efficacy of a novel, biofeedback-based intervention that provides personalized individual-level feedback on biomarkers of lung cancer risk and how they improve in response to cessation, delivered in a gain-framed way. The biomarkers include skin carotenoid status, spirometry, and plasma bilirubin, all of which improve with cessation. The study team will examine whether the biofeedback prevents relapse in those who quit and leads to reductions in smoking in lung nodule patients who failed to quit. Additionally, this study will attempt to evaluate the impact of smoking cessation on miRNA profiles in human serum, especially miRNAs in the let-7 family, which are known to have tumor suppressor function, and which we hypothesize increase in response to cessation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current Smoker.
- •20 pack per year smoking history.
- •Eligible for the Smilow treatment program.
- •Willing to enroll in smoking cessation program.
- •Willing to be randomized in smoking cessation study.
- •English speaking.
Exclusion Criteria
- •Dementia or current serious psychiatric or unstable medical illness.
- •Pregnancy or breast feeding.
- •Known fat malabsorption diseases that may affect skin carotenoid status.
Outcomes
Primary Outcomes
Smoking Cessation
Time Frame: 8 weeks
Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
Number of cigarettes smoked
Time Frame: 6 months
Number of cigarettes smoked will be assessed by self report. Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.
Secondary Outcomes
- Smoking Cessation(Baseline, 4 Weeks, 3 Months)
- Plasma Bilirubin(Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months)
- Skin Carotenoids(Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months)
- Expired Air(Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months)