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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Biofeedback
• Intervention / Treatment: Other: standard care; Behavioral: bio feedback; Behavioral: personalized cessation care

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.

• Study Type: Interventional
• Enrollment (Anticipated): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina: Hollings Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Care/No Bio Feedback; 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.	Other: standard care
Other: Standard Care/ 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.	Other: standard care; 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: Personalized Care/ No Bio Feedback; 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.	Other: standard care; 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
Experimental: Personalized Care/ 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.	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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.	8 weeks
Number of cigarettes smoked	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Cessation	Smoking cessation will be measured by self report and validated by the study team using Carbon Monoxide (CO) levels. CO will be measured.	Baseline, 4 Weeks, 3 Months
Expired Air	A hand held spirometer will be used to measure the volume of air expired by the lungs.	Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months
Skin Carotenoids	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.	Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months
Plasma Bilirubin	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.	Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Brenda Cartmel, PhD, Yale University

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: January 14, 2016
• First Submitted That Met QC Criteria: January 14, 2016
• First Posted (Estimate): January 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1505015965; 1P50CA196530-01 (U.S. NIH Grant/Contract)