Lung Cancer Clinical Trial
Official title:
Capitalizing on Hospitalization to Engage Low SES Smokers in LDCT Screening: A Randomized Controlled Trial
Verified date | July 2019 |
Source | Boston University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Current smokers who undergo annual low dose CT (LDCT) lung cancer screening and successfully quit smoking derive the greatest reduction in lung cancer mortality. Unfortunately, those at highest risk of lung cancer death- those with low socioeconomic status, blacks, and current smokers- are the same individuals that typically have reduced access to preventive healthcare such as smoking cessation services and screening tests. Furthermore, patients from underserved communities often have lower health literacy, less awareness of lung cancer screening, and a poor understanding of the trade-offs of LDCT screening. In 2015 the Center for Medicare and Medicaid Services began requiring (1) a shared decision-making (SDM) discussion including use of a patient decision aid and (2) smoking cessation counseling in order to receive reimbursement for LDCT screening. There is little guidance, however, to help healthcare systems implement this requirement. Furthermore, primary care physicians (PCPs) report time constraints, competing demands, and knowledge deficiencies as barriers to optimizing utilization of LDCT screening.
Status | Completed |
Enrollment | 102 |
Est. completion date | July 1, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility |
Inclusion Criteria: - hospitalized smokers at BMC meeting LDCT screening eligible criteria - males and females 55-80 years of age - =30-pack years smoking - current smoker - able to speak, read, and understand English - able and willing to participate and provide informed consent Exclusion Criteria: - severe co-morbidities expected to limit life expectancy or ability to tolerate surgical resection of a lung cancer, including patients requiring home oxygen therapy (an indicator of severe lung or heart disease), and patients with active cancer - patients who have already had LDCT screening in the past year |
Country | Name | City | State |
---|---|---|---|
United States | Boston Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University | American Lung Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Completion of LDCT screening | The electronic records review and from the Lung Cancer Screening clinical database created by the Department of Pulmonary Disease and Critical Care at BMC will be reviewed to determine which participants have completed LDCT screening designated as yes or no and if yes the date of the LDCT screening will be recorded.. | 3 months | |
Secondary | Knowledge of LDCT screening (experimental group) | A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening. The mean percentage of correct responses will be measured so higher scores are better suggesting more knowledge about LDCT screening. | Baseline, immediately post SDM, 1 month | |
Secondary | Knowledge of LDCT screening (active comparator group) | A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening. | Baseline, 1 month | |
Secondary | smoking cessation | Dichotomous outcome by self-report of prolonged abstinence at 4 weeks and 7-day point prevalence at 4 weeks, as recommended by the Society for Research on Nicotine and Tobacco and the Russell Standard. | 4 weeks |
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