Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
2 other identifiers
interventional
276
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 14, 2016
CompletedFirst Posted
Study publicly available on registry
January 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedApril 21, 2023
April 1, 2023
4.8 years
January 14, 2016
April 20, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Smoking Cessation
Baseline, 4 Weeks, 3 Months
Expired Air
Screening (1 week prior to baseline), Baseline, 8 Weeks, 3 Months, 6 Months
Skin Carotenoids
Screening (1 week prior to baseline), Baseline, 6 Weeks, 8 Weeks, 3 Months, 6 Months
Plasma Bilirubin
Screening (1 week prior to baseline), 6 Weeks, 8 Weeks, 3 Months, 6 Months
Study Arms (4)
Standard Care/No Bio Feedback
OTHERThis 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/ Bio Feedback
OTHERThis arm will consist of those first randomized to be enrolled in the standard care arm and then those enrolled in the bio feedback arm.
Personalized Care/ No Bio Feedback
OTHERThis 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 Care/ Bio Feedback
EXPERIMENTALThis arm will consist of those first randomized to be enrolled in the personalized care arm and then those enrolled in the bio feedback arm.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- Current Smoker.
- 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.
You may not qualify if:
- Dementia or current serious psychiatric or unstable medical illness.
- Pregnancy or breast feeding.
- Known fat malabsorption diseases that may affect skin carotenoid status.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Yale University
New Haven, Connecticut, 06511, United States
Medical University of South Carolina: Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Related Publications (1)
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.
PMID: 37977486DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Cartmel, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2016
First Posted
January 18, 2016
Study Start
January 1, 2016
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
April 21, 2023
Record last verified: 2023-04