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

Yale University

Status: Completed

Conditions: Biofeedback; Smoking Cessation

Treatments: Behavioral: personalized cessation care; Behavioral: bio feedback; Other: standard care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02658032

1505015965

1P50CA196530-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 276 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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276 participants in 4 patient groups

Standard Care/No Bio Feedback

Other group

Description:

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.

Treatment:

Other: standard care

Standard Care/ Bio Feedback

Other group

Description:

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.

Treatment:

Other: standard care

Behavioral: bio feedback

Personalized Care/ No Bio Feedback

Other group

Description:

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.

Treatment:

Behavioral: personalized cessation care

Other: standard care

Personalized Care/ Bio Feedback

Experimental group

Description:

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.

Treatment:

Behavioral: personalized cessation care

Behavioral: bio feedback