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

• ClinicalTrials.gov Identifier: NCT02658032
• Recruitment Status: Active, not recruiting
• First Posted: January 18, 2016
• Last Update Posted: April 9, 2020
• Sponsor: Yale University
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation; Biofeedback	Behavioral: personalized cessation care; Behavioral: bio feedback; Other: standard care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 276 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
• Study Start Date: January 2016
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2024

Arms and Interventions

Arm	Intervention/treatment
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
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.	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
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.	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; Other: standard care
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: 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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06511

United States, South Carolina

Medical University of South Carolina: Hollings Cancer Center

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Yale University

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Brenda Cartmel, PhD; Yale University

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02658032
• Other Study ID Numbers: 1505015965; 1P50CA196530-01 ( U.S. NIH Grant/Contract )
• First Posted: January 18, 2016
• Last Update Posted: April 9, 2020
• Last Verified: April 2020