Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
NCT ID: NCT02658032
Last Updated: 2023-04-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
276 participants
INTERVENTIONAL
2016-01-31
2020-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Tobacco Treatment in the Context of Lung Cancer Screening
NCT03927989
The Lung Screening, Tobacco and Health Project
NCT03200236
Gain-framed Messages and NRT for Lung Cancer Screening Patients
NCT03069924
Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
NCT00002520
Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening
NCT04798664
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
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.
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
standard care
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
standard care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Pregnancy or breast feeding.
* Known fat malabsorption diseases that may affect skin carotenoid status.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Yale University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Brenda Cartmel, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Yale University
New Haven, Connecticut, United States
Medical University of South Carolina: Hollings Cancer Center
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cartmel B, Fucito LM, Bold KW, Neveu S, Li F, Rojewski AM, Gueorguieva R, O'Malley SS, Herbst RS, Toll BA. Effect of a Personalized Tobacco Treatment Intervention on Smoking Abstinence in Individuals Eligible for Lung Cancer Screening. J Thorac Oncol. 2024 Apr;19(4):643-649. doi: 10.1016/j.jtho.2023.11.012. Epub 2023 Nov 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1505015965
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.