NCT02658032

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation
• Biofeedback

Interventions

Type	Name	Description
BEHAVIORAL	personalized cessation care	Individuals randomized to this condition will receive standard care (i.e., 5 counseling sessions and nicotine patch(NRT)) and 4 personalized videos with 5 packages of personalized print materials
BEHAVIORAL	bio feedback	Individuals randomized to this group will be provided with a personalized graph of their biomarker data from baseline, 6 and 8 weeks at the 8-week and 3-month study visits.
OTHER	standard care

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2016-01-18
• Last updated: 2023-04-21

Locations

2 sites across 1 country: United States