Clinical trial NCT02658032: Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
Official title: Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Biofeedback
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-01-18
Enrollment: 276
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Smoking Cessation
timeFrame: 8 weeks
measure: Number of cigarettes smoked
timeFrame: 6 months
Secondary outcomes:
measure: Smoking Cessation
timeFrame: Baseline, 4 Weeks, 3 Months
measure: Expired Air
timeFrame: Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months
measure: Skin Carotenoids
timeFrame: Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months
measure: Plasma Bilirubin
timeFrame: Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Charleston
country: United States
facility: Medical University of South Carolina: Hollings Cancer Center
state: South Carolina
Study officials:
affiliation: Yale University
name: Brenda Cartmel, PhD
role: PRINCIPAL_INVESTIGATOR
References: