Smoking Cessation Clinical Trial
Official title:
Personalized Intervention Program: Tobacco Treatment for Patients at Risk for Lung Cancer (PIP)
Verified date | April 2023 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 276 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina: Hollings Cancer Center | Charleston | South Carolina |
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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