Trial Summary
What is the purpose of this trial?This implementation study will examine the best ways to refer heavy smokers to information about lung cancer screening.
Is the treatment in the trial 'Education on Lung Cancer Screening for Smokers' a promising treatment?Yes, the treatment is promising because it helps increase awareness and participation in lung cancer screening among smokers, which can lead to early detection and potentially save lives.124913
What safety data exists for the educational intervention on lung cancer screening for smokers?The educational intervention, including models like the Patient Navigator Model, has been evaluated in various studies. One study involved a pragmatic randomized controlled trial using telephone-based navigation to address barriers to lung cancer screening. This study identified 559 barriers among 225 patients but did not report any safety concerns related to the educational intervention itself. Another study assessed the benefits and harms of lung cancer screening, noting a 9.2% false-positive rate and 0.8% procedures resulting from false positives, but no major complications were reported. Overall, the educational interventions are focused on improving screening uptake and adherence without direct safety risks associated with the intervention itself.58101214
What data supports the idea that Education on Lung Cancer Screening for Smokers is an effective treatment?The available research shows that educational interventions, like the Patient Navigator Model, can help improve lung cancer screening rates, especially among racially and ethnically minoritized groups. For example, community-level interventions focusing on engagement and education have shown potential in reaching these groups. Additionally, a study using patient navigation found that addressing personal and provider-related barriers through education and support significantly reduced obstacles to screening. This suggests that educational interventions can effectively increase participation in lung cancer screening.3671112
Do I have to stop taking my current medications to join the trial?The trial protocol does not specify whether you need to stop taking your current medications.
Eligibility Criteria
This trial is for English-speaking staff members of a quitline, aged between 55-80 years, who have smoked the equivalent of a pack a day for at least 30 years. It's also open to current smokers or those who've quit within the last 15 years. People with a history of lung cancer cannot participate.Inclusion Criteria
I am currently smoking or quit smoking less than 15 years ago.
Exclusion Criteria
I have been diagnosed with lung cancer.
Treatment Details
The study is testing educational interventions and surveys to determine effective methods for informing heavy smokers about lung cancer screening options through tobacco quitlines.
2Treatment groups
Experimental Treatment
Group I: Callers substudy (LCS educational materials, questionnaire)Experimental Treatment2 Interventions
Participants are referred to lung cancer screening educational materials. Participants also complete questionnaires at 1 week and 6 months after referral to educational materials.
Group II: Call center staff (educational intervention)Experimental Treatment2 Interventions
Participants undergo training consisting of a 60-minute educational session.
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Risk perceptions among participants undergoing lung cancer screening: baseline results from the National Lung Screening Trial. [2022]Lung cancer screening could present a "teachable moment" for promoting smoking cessation and relapse prevention. Understanding the risk perceptions of older individuals who undergo screening will guide these efforts.
Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial. [2023]The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history≥30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.
Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. [2018]Assess patient adherence to radiologist recommendations in a clinical CT lung cancer screening program.
Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial. [2019]Annual chest computed tomography (CT) can decrease lung cancer mortality in high-risk individuals. Patient navigation improves cancer screening rates in underserved populations. Randomized controlled trial was conducted from February 2016 to January 2017 to evaluate the impact of a patient navigation program on lung cancer screening (LCS) among current smokers in five community health centers (CHCs) affiliated with an academic primary care network. We randomized 1200 smokers aged 55-77 years to intervention (n = 400) or usual care (n = 800). Navigators contacted patients to determine LCS eligibility, introduce shared decision making about screening, schedule appointments with primary care physicians (PCPs), and help overcome barriers to obtaining screening and follow-up. Control patients received usual care. The main outcome was the proportion of patients who had any chest CT. Secondary outcomes were the proportion of patients contacted, proportion receiving LCS CTs, screening results and number of lung cancers diagnosed. Of the 400 intervention patients, 335 were contacted and 76 refused participation. Of the 259 participants, 124 (48%) were ineligible for screening; 119 had smoked
Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers. [2023]Lung cancer screening is a relatively new screening option. Inequalities related to screening behavior have been documented in other types of cancer screening. Because stage at presentation drives mortality in lung cancer, it is critical to understand factors that influence screening behavior in lung cancer screening in order to intervene. However, we must first understand where disparities exist in lung cancer screening participation in order to effectively guide intervention efforts. Therefore, the purpose of this study was to determine the association of sociodemographic (including key disparity-related variables) and knowledge with lung cancer screening behavior. This cross-sectional, descriptive study used survey methodology to collect data from 438 screening-eligible individuals in the state of Indiana between January and February 2017 and measured sociodemographic variables and knowledge about lung cancer and screening. Key sociodemographic and health status characteristics associated with screening behavior included race, geographic area of residence, income, health insurance, and family history of lung cancer. Of the variables generally reflective of disparities, key differences were noted by race and geographic area of residence with total knowledge scores as well as screening behavior, respectively. Results indicate key differences in race and geographic area of residence that may perpetuate screening behavior disparities. We have a unique opportunity at this early implementation stage in lung cancer screening to learn what variables influence screening behavior from our target patient population. This knowledge can be used to design equitable patient outreach programs, meaningful, tailored patient engagement materials, and effective patient-clinician decision support tools.
An Analysis of Lung Cancer Screening Beliefs and Practice Patterns for Community Providers Compared to Academic Providers. [2023]Despite guidelines recommending annual low-dose computed tomography (LDCT) screening for lung cancer, uptake remains low due to the perceived complexity of initiating and maintaining a clinical program-problems that likely magnify in underserved populations. We conducted a survey of community providers at Federally Qualified Health Centers (FQHCs) in Santa Clara County, California, to evaluate provider-related factors that affect adherence. We then compared these findings to academic providers' (APs) LDCT screening knowledge, behaviors, and attitudes at an academic referral center in the same county. The 4 FQHCs enrolled care for 80 000 patients largely of minority descent and insured by Medi-Cal. Of the 75 FQHC providers (FQHCPs), 36 (48%) completed the survey. Of the 36 providers, 8 (22%) knew screening criteria. Fifteen (42%) FQHCPs discussed LDCT screening with patients. Compared to 36 APs, FQHCPs were more concerned about harms, false positives, discussion time, patient apathy, insurance coverage, and a lack of expertise for screening and follow-up. Yet, more FQHCPs thought screening was effective (27 [75%] of 36) compared to APs ( P = .0003). In conclusion, provider knowledge gaps are greater and barriers are different for community clinics caring for underserved populations compared to their academic counterparts, but practical and scalable solutions exist to enhance adoption.
Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. [2023]The Centers for Medicare and Medicaid Services has mandated in-person shared decision-making (SDM) counseling with the use of one or more decision aids (DAs) prior to lung cancer screening. We developed a single-page, paper-based, encounter DA (EDA) to be used within a clinician-patient encounter for lung cancer screening and conducted a pre-post pilot intervention study to evaluate its feasibility and effects on patient decisional conflict. Patients referred to a pulmonary practice-based lung cancer screening program were surveyed before and after an SDM visit with a pulmonologist, who used the EDA to counsel the patient. Patient knowledge of the mortality benefit from screening and the frequency of abnormal screening test results was evaluated after the visit, while decisional conflict was measured before and after the visit using the Decisional Conflict Scale (DCS). Twenty-three patients participated (mean age = 65.8 years; 43% female; mean smoking history = 57.8 pack-years; 48% currently smoking). Following the visit, 28% of participants correctly understood the mortality benefit of lung cancer screening, while 82% understood the frequency of abnormal screening tests. The mean total DCS score decreased from 35.0 to 0.2 after the visit (p
Quantifying Benefits and Harms of Lung Cancer Screening in an Underserved Population: Results From a Prospective Study. [2023]Lung cancer screening with annual low-dose computed tomography reduces lung cancer death by 20-26%. However, potential harms of screening include false-positive results, procedures from false positives, procedural complications and failure to adhere to follow-up recommendations. In diverse, underserved populations, it is unknown if benefits of early lung cancer detection outweigh harms. We conducted a prospective observational study of lung cancer screening participants in an urban, safety-net institution from September 2014 to June 2020. We measured benefits of screening in terms of cancer diagnosis, stage, and treatment. We measured harms of screening by calculating false-positive rate, procedures as a result of false positive screens, procedural complications, and failure to follow-up with recommended care. Of patients with 3-year follow up, we measured these same outcomes in addition to compliance with annual screening. Of 1509 participants, 55.6% were African American, 35.2% White, 8.1% Hispanic, and 0.5% Asian. Screening resulted in cancer detection and treatment in 2.8%. False positive and procedure as a result of a false positive occurred in 9.2% and 0.8% of participants, respectively with no major complications from diagnostic procedures or treatment. Adherence to annual screening was low, 18.7%, 3.7%, and 0.4% at 1, 2, and 3 years after baseline screening respectively. Multidisciplinary lung cancer screening in a safety-net institution can successfully detect and treat lung cancer with few harms of false-positive screens, procedure after false-positive screens and major complications. However, adherence to annual screening is poor.
Adapting Community Educational Programs During the COVID-19 Pandemic: Comparing the Feasibility and Efficacy of a Lung Cancer Screening Educational Intervention by Mode of Delivery. [2023]Few eligible patients receive lung cancer screening. We developed the Lung AIR (awareness, information, and resources) intervention to increase community education regarding lung cancer screening. The intervention was designed as an in-person group intervention; however, the COVID-19 pandemic necessitated adapting the mode of delivery. In this study we examined intervention feasibility and efficacy overall and by mode of delivery (in-person group vs. one-on-one phone) to understand the impact of adapting community outreach and engagement strategies. Feasibility was examined through participant demographics. Efficacy was measured through pre/post knowledge, attitudes, and beliefs about lung cancer screening, and intention to complete screening. We reached N = 292 participants. Forty percent had a household income below $35,000, 58% had a high school degree or less, 40% were Hispanic, 57% were Black, and 84% reported current or past smoking. One-on-one phone sessions reached participants who were older, had lower incomes, more current smoking, smoked for more years, more cigarettes per day, lower pre-intervention lung cancer screening knowledge, and higher pre-intervention fear and worry. Overall pre/post test scores show significant increases in knowledge, salience, and coherence, and reduced fear and worry. Participants in the one-on-one phone sessions had significantly higher increases in salience and coherence and intention to complete screening compared to participants in the in-person group sessions. The Lung AIR intervention is a feasible and effective community-based educational intervention for lung cancer screening. Findings point to differences in reach and efficacy of the community-based intervention by mode of delivery.
Provider and patient perspectives to improve lung cancer screening with low-dose computed tomography 5 years after Medicare coverage: a qualitative study. [2022]Lung cancer remains the leading cause of cancer-related deaths for both men and women in the U.S., yet uptake of preventive cancer screening for people with a heavy smoking history remains low. This qualitative interview study of patients and providers from a large ambulatory healthcare system in northern and central California reevaluated perceptions of lung cancer screening with low-dose computed tomography (LCS-LDCT) 5 years after Medicare coverage. We hypothesized that initial attitudes and barriers within the LCS-LDCT discussion and process have likely persisted with little change since Medicare coverage and we sought to understand how these attitudes continue to impact effective implementation and uptake of screening with the goal of identifying opportunities for improvement. Between 2019 and 2020, interviews were conducted with 10 primary care physicians and 30 patients using semi-structured interview guides. Providers and patients expressed that they were both aware and supportive of LCS-LDCT, a change from earlier studies, but continued to report little to no shared decision making nor use of a decision aid despite being Medicare requirements. Creation and incorporation of a single-page, graphic heavy decision aid may help address many of the persistent barriers around implementation for both providers and patients. Given recently expanded guidelines from the U.S. Preventive Services Task Force for LCS-LDCT screening and their coverage by Medicare, it is important for healthcare systems to understand provider and patient perceptions to further improve the implementation of LCS-LDCT to ultimately reduce lung cancer mortality.
Interventions to improve lung cancer screening among racially and ethnically minoritized groups: A scoping review. [2023]Lung cancer screening (LCS) decreases lung cancer related mortality among high-risk people who smoke cigarettes and has been endorsed by the US Preventive Services Task Force (USPSTF) since 2013. However, adoption of LCS has been limited, and disparities in LCS among racially and ethnically minoritized groups have become apparent. While recommendations to improve disparities in LCS have been made, there is a lack of information on how these recommendations have been implemented and their relative effectiveness in improving screening disparities. This scoping review addresses this knowledge gap by examining interventions that have been implemented to improve LCS among racially and ethnically minoritized groups in the United States. A comprehensive search of MEDLINE (via PubMed), EMBASE (via Elsevier), CINAHL Complete (via EBSCO), and Scopus (via Elsevier), for articles from the period 1 January 2010 through 22 October 2021 was completed. Out of 17,045 references screened, only 11 studies describing an intervention to improve disparities in LCS were identified, underscoring the dearth of data on established interventions. The interventions discussed could be categorized into three groups -- patient level (n = 3), clinic/institution level (n = 3), and community level (n = 5) interventions. Of those studies reporting effectiveness data (n = 8), there was substantial heterogeneity in the outcomes measured and their relative effectiveness. We found that interventions which streamlined the LCS process at the level of a single clinic or institution were the most effective in improving LCS. Community-level interventions that focused on engagement and education had the greatest potential to target racially and ethnically minoritized groups. Our study underscores the need for more robust research on addressing barriers to LCS by identifying effective patient, clinic, and community-level interventions to improve LCS disparities and the need for potential standardization of intervention effectiveness outcomes.
Assessing Barriers and Facilitators to Lung Cancer Screening: Initial Findings from a Patient Navigation Intervention. [2023]Low-dose computed tomography-based lung cancer screening represents a complex clinical undertaking that could require multiple referrals, appointments, and time-intensive procedures. These steps may pose difficulties and raise concerns among patients, particularly minority, under-, and uninsured populations. The authors implemented patient navigation to identify and address these challenges. They conducted a pragmatic randomized controlled trial of telephone-based navigation for lung cancer screening in an integrated, urban safety-net health care system. Following standardized protocols, bilingual (Spanish and English) navigators educated, motivated, and empowered patients to traverse the health system. Navigators made systematic contact with patients, recording standardized call characteristics in a study-specific database. Call type, duration, and content were recorded. Univariable and multivariable multinomial logistic regression was performed to investigate associations between call characteristics and reported barriers. Among 225 patients (mean age 63 years, 46% female, 70% racial/ethnic minority) assigned navigation, a total of 559 barriers to screening were identified during 806 telephone calls. The most common barrier categories were personal (46%), provider (30%), and practical (17%). System (6%) and psychosocial (1%) barriers were described by English-speaking patients, but not by Spanish-speaking patients. Over the course of the lung cancer screening process, provider-related barriers decreased 80% (P = 0.008). The authors conclude that patients undergoing lung cancer screening frequently report personal and health care provider-related barriers to successful participation. Barrier types may differ among patient populations and over the course of the screening process. Further understanding of these concerns may increase screening uptake and adherence. Clinical Trial Registration number: (NCT02758054).
Strategies to deliver smoking cessation interventions during targeted lung health screening - a systematic review and meta-analysis. [2023]Lung cancer screening presents an important teachable moment to promote smoking cessation, but the most effective strategy to deliver support in this context remains to be established.
The tobacco quitline setting as a teachable moment: The Educating Quitline Users About Lung (EQUAL) cancer screening randomized trial. [2023]Although lung cancer screening (LCS) using low-dose CT is recommended for high-risk individuals, screening adherence remains low. We conducted a randomized trial to compare two methods of providing LCS education to Maryland Tobacco Quitline (MTQ) callers in order to assess whether this setting may serve as a teachable moment for LCS-eligible individuals. MTQ callers (50-80 years, 20+ pack-years, prior LCS ≥12 months) completed the baseline and were randomized to the Print- or Web-based version of ShouldIScreen.com. Participants completed 1- and 4-month follow-up assessments to evaluate intervention engagement and LCS-related outcomes. Participants (Print = 152, Web = 146) were 61.7 (SD = 6.3) years old and reported 63.5 pack-years (SD = 36.0). Most identified as Black (54.2%), female (66.1%), having internet access (78.9%), completing other recommended cancer screenings (86.3%), and that they would undergo LCS if recommended by their provider (91.3%). By 4 months, significantly more Print (75.0%) than Web (61.6%) participants had read the materials (P = .01). Most reported the interventions contained "the right amount" of information (92.6%) and prepared them to talk with their doctor (57.2%). Regarding screening-related outcomes, 42.8% (Print) and 43.8% (Web) had scheduled or completed a low-dose CT scan or a shared decision-making visit (P = .86). In a racially diverse sample of LCS-eligible quitline callers, offering LCS educational materials resulted in high intervention engagement and screening-related appointments. As >20% did not have internet access, providing participants' preferred modality (web/print) may improve intervention engagement and knowledge. Improving LCS awareness represents an important opportunity to increase screening among eligible but unscreened quitline callers.