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

Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:50 - Any
Start Date:January 2016
End Date:January 2024
Contact:Brenda Cartmel, PhD

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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.

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

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.

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.
We found this trial at
New Haven, Connecticut 6520
(203) 432-4771
Phone: 203-737-2015
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New Haven, CT
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Charleston, South Carolina 29425
Phone: 843-876-1132
Charleston, SC
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