Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)

Not Applicable

Completed

Interventions: Behavioral: personalized cessation care
Behavioral: bio feedback
Other: standard care

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Personalized Care/ Bio Feedback	bio feedback	This arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the bio feedback arm.
Standard Care/ Bio Feedback	bio feedback	This arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the bio feedback arm.
Personalized Care/ No Bio Feedback	personalized cessation care	This arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the non bio feedback arm.
Personalized Care/ No Bio Feedback	standard care	This arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the non bio feedback arm.
Standard Care/No Bio Feedback	standard care	This arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the non bio feedback arm.
Standard Care/ Bio Feedback	standard care	This arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the bio feedback arm.
Personalized Care/ Bio Feedback	personalized cessation care	This arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the bio feedback arm.

Primary Outcome Measures

Name	Time	Method
Smoking Cessation	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	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 Outcome Measures

Name	Time	Method
Plasma Bilirubin	Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months	3 mls of blood will be drawn into heparinized tubes, centrifuged, and plasma transferred to opaque tubes and analyzed on the Roche DPP Modular automated chemistry analyzer at the clinical lab, using the method of Jendrassik and Grof. While indirect (unconjugated) bilirubin is likely more relevant for health effects, it is very highly correlated with total bilirubin, which is more common for physicians to test and thus more relevant for translational purposes. Thus, total bilirubin will be used for feedback.
Skin Carotenoids	Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months	Skin carotenoids are measured with a 30-second scan of the skin with visible light can be used to quantify skin carotenoids rapidly and non-invasively. This study's method sufficiently measures carotenoid status in skin as a biomarker of response to a smoking cessation intervention.
Expired Air	Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months	A hand held spirometer will be used to measure the volume of air expired by the lungs.
Smoking Cessation	Baseline, 4 Weeks, 3 Months	Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.

Locations (2): Medical University of South Carolina: Hollings Cancer Center
🇺🇸
Charleston, South Carolina, United States
Yale University
🇺🇸
New Haven, Connecticut, United States