Utilizing a patient advocacy-led clinical network to engage diverse, community-based sites in implementation-effectiveness research. 

Date published: 2024 Aug 5 Authors: Ciupek A, Chichester LA, Acharya R, Schofield E, Criswell A, Shelley D, King JC, Ostroff JS Journal: BMC Health Serv Res

Increased engagement with community-based practices is a promising strategy for increasing clinical trials access of diverse patient populations. In this study we assessed the ability to utilize a patient-advocacy organization led clinical network to engage diverse practices as field sites for clinical research. GO2 for Lung Cancer led recruitment efforts of 17 field sites from their Centers of Excellence in Lung Cancer Screening Network for participation in an implementation-effectiveness trial focused on smoking cessation integration into screening programs for lung cancer. Sites were engaged by one of three methods: 1) Pre-Grant submission of letters of support, 2) a non-targeted study information dissemination campaign to network members, and 3) proactive, targeted outreach to specific centers informed by previously submitted network member data. Detailed self-reported information on barriers to participation was collected from centers that declined to join the study. Of 17 total field sites, 16 were recruited via the targeted outreach campaign and 1 via pre-grant letter of support submission. The sites covered 13 states and 4 United States geographic regions, were varied in annual screening volumes and years of screening program experience and were predominantly community-based practices (10 of 17 sites). The most reported reason (by 33% of sites) for declining to participate as a field site was inadequate staffing bandwidth for trial activities. This was especially true in community-based programs among which it was reported by 45% as a reason for declining. Our results suggest that this model of field site recruitment leveraging an existing partnership between an academic research team and an informal clinical network maintained by a disease-specific patient advocacy organization can result in engagement of diverse, community-based field sites. Additionally, reported barriers to participation by sites indicate that solutions centered around providing additional resources to enable greater capacity for site staff may increase community-practice participation in research.

Implementing computed tomography-based lung cancer screening in the community. 

Date published: 2024 Sep 13 Authors: Mulshine J, Ambrose LF Journal: Journal of Thoracic Disease

CT-based lung cancer screening was recommended as a proven cancer early lung cancer detection test after extensive evaluation and the finding of a 20% mortality reduction in the National Cancer Institute sponsored, National Lung Screening Trial (NLST). That study took just under ten years and a quarter of a billion dollars to complete but it conclusively addressed the critical question of whether CT screening could really save lives. Now under provisions of the Affordable Care Act, private insurance companies and federal insurance programs [Center for Medicare and Medicaid Services (CMS)] are reimbursing for CT-based lung cancer screening without deductibles, co-sharing or co-payments to ensure broad access to this new service. This cancer screening service is now being rolled out responsibly in community settings across the country. In the dialogue about providing this service there was considerable discussion about potential harms that could occur with providing this service. For this reason, the recent article from Miller et al. is important new information that outlines a robustly positive preliminary lung cancer screening experience at one community hospital system. Given the extent of interest in this new service; it is worth taking a closer look at their experience.

Real‐world analysis of the relationships between smoking, lung cancer stigma, and emotional functioning.

Date published: 2024 Jan Authors: Chansky K, Rigney M, King JC Journal: Cancer Medicine

People diagnosed with lung cancer experience high rates of distress, which can be compounded by the stigma of the disease. This study assessed a real-world population to understand patient-reported emotional functioning, types of stigmas experienced, and relationship with smoking history. Questionnaires using validated survey tools assessing demographics, smoking history, stigma, and quality of life (EORTC QLQ-C30 Emotional Functioning Scale) were analyzed from 539 global participants in the Lung Cancer Registry between November 2019 and July 2022. The associations between smoking history and self-reported internalized and perceived stigma and constrained disclosure of lung cancer diagnosis, as well as the potential impact of stigma on emotional functioning, were examined using multivariable logistic regression models. Among the broad geographic mix of study participants, all types of lung cancer stigma were associated with decreased emotional functioning due to a combination of factors including depression, anxiety, stress, and irritability. Participants who reported a history of current or former smoking experienced higher levels of internalized stigma and perceived stigma. Constrained disclosure about a diagnosis was common, associated with decreased emotional functioning, and not related to a history of smoking. Smoking status itself was not associated with reduced emotional functioning, implicating the role of stigma in distress. In this study, all types of lung cancer stigma were associated with clinically important decreases in emotional functioning. This impact was not dependent on smoking history. Internalized and perceived stigma were associated with the presence of a smoking history. These findings have implications for proper psychosocial care of people diagnosed with lung cancer.

Health inequities across the lung cancer care continuum in ten marginalized populations: a narrative review.

Date Published: 2023 Nov Authors: Monestime S, Rigney M, Phipps N, Carlson C, Alongi T, Redding M, and King JC Journal: Journal of Thoracic Disease

Lung cancer remains the deadliest cancer in the United States. Although lung cancer screening and innovative treatment options are available, accessing these interventions remains a barrier for marginalized communities due to social and structural challenges that influence health care access. These barriers have led to worse outcomes when compared to Non-Hispanic Whites (NHW) and non-marginalized populations. The objective of this study is to examine disparities in lung cancer and social/structural factors within ten critical populations (racial/ethnic minorities, low income, rural, LGBTQIA+, women, veteran and active duty, and small cell lung cancer) across the continuum of lung cancer care. Five databases (PubMed, the Cochrane Library, EMBASE, Web of Knowledge, and EBSCO Discovery Service) were queried from February 2022–June 2022. The inclusion criteria were (I) peer-reviewed academic journals published in English between the years 2000 and 2022; (II) research that focused on disparities across the lung cancer continuum; and (III) research articles addressing social and structural barriers to lung cancer health care access. A total of 95 articles and 24 reports were used for this narrative review. Across the ten populations, consistent disparities were observed in lung cancer screening and treatment, exhibited by lower uptake in screening, treatment, clinical trials, and biomarker testing. Significant themes contributing to these disparities were socioeconomic status, transportation, language, historic trauma, provider bias or lack of cultural training, and lack of health care access, in part due to insurance coverage. Future studies are needed to further develop meaningful solutions to disparities in health outcomes and access for those who are at risk, diagnosed with, or surviving lung cancer from marginalized populations. 

Germline EGFR mutations and familial lung cancer.

Date Published: 2023 Oct Authors: Oxnard GR, Chen R, Pharr JC, Koeller DR, Bertram AA, Dahlberg SE, Rainville I, Shane-Carson K, Taylor KA, Sable-Hunt A, Sholl LM, Teerlink CC, Thomas A, Cannon-Albright LA, Fay AP, Ashton-Prolla P, Yang H, Salvatore MM, Addario BJ, Janne PA, Carbone DP, MD, Wiesner GL, and Garber JE Journal: Journal of Clinical Oncology

The genomic underpinnings of inherited lung cancer risk are poorly understood. This prospective study characterized the clinical phenotype of patients and families with germline EGFR pathogenic variants (PVs). The Investigating Hereditary Risk from T790M study (ClinicalTrials.gov identifier: NCT01754025) enrolled patients with lung cancer whose tumor profiling harbored possible germline EGFR PVs and their relatives, either in person or remotely, providing germline testing and follow-up. A total of 141 participants were enrolled over a 5-year period, 100 (71%) remotely. Based on previous genotyping, 116 participants from 59 kindreds were tested for EGFR T790M, demonstrating a Mendelian inheritance pattern previous genotyping, 116 participants from 59 kindreds were tested for EGFR T790M, demonstrating a pattern of Mendelian inheritance with variable lung cancer penetrance. In confirmed or obligated carriers of a germline EGFR PV from 39 different kindreds, 50/91 (55%) were affected with lung cancer with 34/65 (52%) diagnosed by age 60 years. Somatic testing of lung cancers in carriers revealed that 35 of 37 (95%) had an EGFR driver co-mutation. Among 36 germline carriers without a cancer diagnosis, 15 had computed tomography (CT) imaging, and nine had lung nodules, including a 28-year-old with >10 lung nodules. Given geographic enrichment of germline EGFR T790M in the southeast United States, genome-wide haplotyping of 46 germline carriers was performed and identified a 4.1-Mb haplotype shared by 41 (89%), estimated to originate 223-279 years ago. To our To the best of our knowledge, this is the first prospective description of familial EGFR-mutant lung cancer, identifying a recent founder germline EGFR T790M variant enriched in the Southeast United States. The high prevalence of EGFR-driver lung adenocarcinomas and lung nodules in germline carriers supports efforts to identify affected patients and family members for investigation of CT-based screening for these high-risk individuals.

Longitudinal nucleocapsid antibody testing reveals undocumented SARS-CoV-2 infections in patients with lung cancer.

Date Published: 2023 Oct Authors: Rodilla AM, Valanparambil RM, Mack PC, Hsu CY, Cagan J, Tavolacci SC, Carreño JM, Brody R, Moore A, King JC, Gomez JE, Rohs N, Rolfo C, Bunn PA Jr, Gerber DE, Minna JD, Krammer F, Ramalingam SS, García-Sastre A, Shyr Y, Ahmed R, and Hirsch FR Journal: Cancer Cell

Patients diagnosed with lung cancer (LC) exhibit increased susceptibility to SARS-CoV-2 infection. Rodilla et al. monitor the levels of plasma anti-nucleocapsid antibodies within a cohort of fully vaccinated LC patients and reveal that the actual infection rate is nearly twice the documented rate, indicating a significant prevalence of unreported cases.

Sexual Health Assessment in Women with Lung Cancer study: Sexual health assessment in women with lung cancer.

Date Published: 2023 Oct Authors: Florez N, Kiel L, Meza K, Wei Z, Mazzola E, Velazquez AI, Franco I, Fidler MJ, Elkins I, Feldman J, Seaborne L, Heisler C, King JC, Moore A, Wiens J, and Kushner D Journal: Cancer

Sexual health is understudied and underreported in patients with lung cancer, and most data precede the approval of widely used targeted therapies and immune checkpoint inhibitors. The authors sought to evaluate the prevalence of sexual dysfunction in women with lung cancer in our current clinical environment. This cross-sectional survey study was administered online to 249 women via the GO2 for Lung Cancer (GO2) Registry, using the Patient-Reported Outcomes Measurement Information System Sexual Function and Satisfaction Measures questionnaire. Participants were recruited between June 2020 to June 2021. Eligibility criteria included age >18 years, self-identifying as a woman, fluency in English, and a lung cancer diagnosis within 10 years. Most (67%) had stage IV lung cancer and 47% were receiving targeted therapy; 66% were undergoing active treatment. Despite 54% of participants reporting "recent" sexual activity, most (77%) indicated having little to no interest in sexual activity and 48% reported recent minimal satisfaction with their sex life. The most common reasons negatively affecting participants' satisfaction with their sex life included fatigue (40%) and feeling sad/unhappy (28%). Common reasons for lack of recent sexual activity included lack of interest (68%) and vaginal dryness or pain (30%). Compared to pre-diagnosis, women were significantly less likely to have recent interest in sexual activity. In multivariable logistic-regression, vaginal dryness showed a significant negative association with recent interest in sexual activity. Sexual dysfunction is prevalent in women with lung cancer. Sexual health should be integrated into routine care for patients with lung cancer.

Getting ready for prime time: Recommended adaptations of an Empathic Communication Skills training intervention to reduce lung cancer stigma for a national multi-center trial.

Date Published: 2023 Aug Authors: Banerjee SC, Malling CD, Shen MJ, Williamson TJ, Bylund CL, Studts JL, Mullett T, Carter-Bawa L, Hamann HA, Parker PA, Steliga M, Feldman J, Pantelas J, Borondy-Kitts A, Rigney M, King JC, Fathi JT, Rosenthal LS, Smith RA, and Ostroff JS Journal: Translational Behavioral Medicine

Building upon prior work developing and pilot testing a provider-focused Empathic Communication Skills (ECS) training intervention, this study sought feedback from key invested partners who work with individuals with lung cancer (i.e., stakeholders including scientific and clinical advisors and patient advocates) on the ECS training intervention. The findings will be used to launch a national virtually delivered multi-center clinical trial that will examine the effectiveness and implementation of the evidence based ECS training intervention to reduce patients’ experience of lung cancer stigma. A 1-day, hybrid, key invested partners meeting was held in New York City in Fall 2021. We presented the ECS training intervention to all conference attendees (N = 25) to seek constructive feedback on modifications of the training content and platform for intervention delivery to maximize its impact. After participating in the immersive training, all participants engaged in a group discussion guided by semi-structured probes. A deductive thematic content analysis was conducted to code focus group responses into 12 distinct a priori content modification recommendations. Content refinement was suggested in 8 of the 12 content modification themes: tailoring/tweaking/refining, adding elements, removing elements, shortening/condensing content, lengthening/extending content, substituting elements, re-ordering elements, and repeating elements. Engagement and feedback from key invested multi-sector partners is a valuable resource for intervention content modifications. Using a structured format for refining evidence-based interventions can facilitate efforts to understand the nature of modifications required for scaling up interventions and the impact of these modifications on outcomes of interest. 

Patient-reported impact of symptoms in lung cancer (PRISM-LC).

Date Published: 2023 Jul Authors: Varma A, Weinstein J, Seabury J, Rosero S, Zizzi C, Dilek N, Heatwole J, Baumgart M, Mulford D, Maggiore R, Conrow L, King JC, Wiens J, and Heatwole C Journal: Translational Lung Cancer Research

Individuals with lung cancer (LC) face a variety of symptoms that significantly impact their lives. We use extensive patient input to determine the relative importance and prevalence of these symptoms and identify which demographic features are associated with a higher level of disease burden. We performed semi-structured qualitative interviews with participants with LC to identify potentially important symptoms. We then conducted a cross-sectional study, in which participants rated the relative importance of 162 individual symptoms covering 14 symptomatic themes. Participant responses were analyzed by age, sex, disability status, disease duration, LC stage, type of treatment received, and smoking history, among other categories. Our cross-sectional study had 139 participants with LC. The most prevalent symptomatic themes reported by this population were fatigue (85.5%), impaired sleep and daytime sleepiness (73.5%), and emotional issues (73.0%). The symptomatic themes that had the greatest average impact (on a scale of 0 to 4, with 4 being the most impactful) were social role dissatisfaction (1.67), inability to do activities (1.64), and fatigue (1.60). Disability status had the strongest association with symptomatic theme prevalence. LC stage (stage IV), receipt of therapy, and smoking experience were also associated with higher frequency of symptomatic themes. Individuals with LC face diverse and disease-specific symptoms that affect their daily lives. Patient insight on the prevalence and relative importance of these symptoms is invaluable to advance meaningful therapeutic interventions.

A new framework for co-creating telehealth for cancer care with the patient community.

Date Published: 2023 Jul Authors: Addario B, Astratinei V, Binder L, Geissler J, Horn MK, Krebs LU, Lewis B, Oliver K, Spiegel A Journal: Patient

The increased use of telehealth in cancer care during the coronavirus disease 2019 pandemic has added to our knowledge and experience of the modality with benefits in terms of efficacy, cost, and patient and healthcare professional experience reported. However, telehealth has also been found not to be universally available to all patients with cancer, nor to be appropriate for every healthcare interaction; additionally, not all patients prefer it. Now that coronavirus disease restrictions have essentially ended and an opportunity to re-assess telehealth provision in cancer care presents, we offer a framework that aims to ensure that the needs and preferences of the patient community are included in the development of telehealth provision. Stakeholders in this process include patients, patient advocates, healthcare providers, healthcare services commissioners, managers, and policy makers. The framework outlines how patient advocates can work with other stakeholders as equal partners at all stages of telehealth service development. The patient advocate community has a unique understanding of the patient perspective and expertise in healthcare design and delivery. This enables advocates to contribute to shaping telehealth provision, from policy and guideline formulation to patient navigation. Appropriate resources, education, and training may be needed for all stakeholders to support the development of an effective telehealth system. Together with other stakeholders, patient advocates can make an important contribution to optimizing appropriate patient-centered telehealth provision in cancer care.

Patient-led advocacy in ALK-positive lung cancer.

Date Published: 2023 Jun Authors: Barton C, Al Achkar M, Blender JA, Farmen SH, Hall RB, Konidari AM, Martinez D, Pronsati N, Rosenzweig M, Vass C, Venanzi ES, Westlake W, and Muskavitch MAT Journal: Translational Lung Cancer Research

Patient-led advocacy organizations in the anaplastic lymphoma kinase (ALK)-positive lung cancer space are becoming increasingly influential. ALK Positive Inc. (hereafter “ALK Positive”) is probably the most widely known among these organizations. Evolving from a private Facebook Support Group created in 2015 to provide a forum for ALK-positive lung cancer patients and caregivers to exchange information, empathy, and support, ALK Positive transitioned in 2021 into a 501(c)(3) nonprofit organization (NPO), with the mission to improve the life expectancy and quality of life for ALK-positive cancer patients worldwide. This review provides a historical perspective on the growth, activities, and aspirations of ALK Positive to pursue patient advocacy and enable development of new therapies for individuals with ALK-positive cancers. This growth has been enabled by the collaborative efforts of ALK-positive cancer patients, their care partners and oncologists, academic researchers, other NPO advocacy organizations, and members of the biotech and pharma communities who develop new therapies for ALK-positive cancers. ALK Positive has grown to provide a variety of patient services, to award competitive support for translational research and clinical trials intended to enable new therapies and improved quality and extent of life for ALK-positive cancer patients, and to collaborate with industry and academia to accelerate the development of improved therapies for ALK-positive cancer patients. ALK Positive continues grappling with a variety of challenges including further improving patient quality of life, enabling the development of new therapies, and extending its already substantial global reach and impact. This review summarizes many of the tangible impacts and aspirations engendered by ALK Positive for ALK-positive cancer patients in the past, present and future tenses—where we have been, where we stand and where we hope to go. The content is based on the historical recollections of the authors, and is accurate as of November 30, 2022, to the best of the authors’ knowledge.

Leveraging social media to increase lung cancer screening awareness, knowledge, and uptake among high-risk populations (The INSPIRE-Lung Study): study protocol of design and methods of a community-based randomized controlled trial.

Date Published: 2023 May Authors: Carter-Bawa L, Banerjee SC, Comer RS, Kale MS, King JC, Leopold KT, Monahan PO, Ostroff JS, Slaven JE Jr, Valenzona F, Wiener RS, and Rawl SM Journal: Res Sq

Lung cancer is the leading cause of cancer death for both men and women in the United States. The National Lung Screening Trial (NLST) demonstrated that low dose computed tomography (LDCT) screening could reduce lung cancer mortality among high-risk individuals, but uptake of lung screening remains low. Social media platforms have the potential to reach many people, including those who are at high risk for lung cancer but who may not be aware of or have access to lung screening. This paper discusses the protocol for a randomized controlled trial (RCT) that leverages FBTA to reach screening-eligible individuals in the community at large and intervene with a public-facing, tailored health communication intervention (LungTalk ) to increase awareness of and knowledge about lung screening. This study will provide important information to inform the ability to refine implementation processes for national population efforts to scale a public-facing health communication-focused intervention using social media to increase screening uptake of appropriate, high-risk individuals. The trial is registered at clinicaltrials.gov (NCT05824273).

Influences on lung cancer screening initiation and retention in rural Alabama

Date Published: 2023 Apr Authors: Copeland A, Levy K, Hardy CM, King JC, and Rigney M Journal: J Prim Care Community Health

Despite the introduction of lung cancer screening using low dose computed tomography (LDCT), overall screening rates in the U.S. remain low, with certain populations including Black and rural communities experiencing additional disparities. The primary objective of this study was to understand the facilitators of lung cancer screening initiation and retention in Alabama reported by people at risk from mostly rural, mostly Black populations in Jefferson County—including the urban center of Birmingham—and 6 rural counties: Choctaw, Dallas, Greene, Hale, Marengo, and Sumter. We conducted semi-structured telephone interviews with 58 people who underwent lung cancer screening between December 2019 and January 2022. Participant responses were recorded by the interviewer for analysis. Open-ended responses were coded to identify emergent themes. The most reported influences to initiate screening were information or suggestion from a Community Health Advisor (CHAs) or the supervising county coordinator, suggestion from a friend, or consideration of a personal history of smoking. Most participants reported multiple influences. Physicians were not very influential in decisions to initiate screening, but they were extremely influential in participants’ intent to continue screening, both positively and negatively. Knowing the recommended timeline for their annual scans was also a predictor of intention to continue screening. Participants screened during the COVID-19 state of emergency expressed less certainty about dates of next scans and more ambivalence about intention to continue screening. This study shows the benefit of using multiple methods to support increased awareness of and interest in lung cancer screening, particularly when educational messaging through CHAs is used. Clear guideline-based messages from healthcare providers about recommended screening is important for increasing retention. COVID-19 related implementation challenges impacted screening recruitment and retention. Future research is warranted to further explore use of CHAs in lung cancer screening. 

Emphysema detection in the course of lung cancer screening: optimizing a rare opportunity to impact population health.

Date Published: 2023 Apr Authors: Mulshine JL, Aldigé CR, Ambrose LF, Armato SG 3rd, Avila RS, Cham M, Estepar RSJ, Fain SB, Gazourian L, Gierada DS, Hatt C, Henschke CI, Hoyos J, Lynch DA, McGlothlin AK, Oudkerk M, Pasquinelli M, Pinsky P, Pyenson B, Rizzo AA, Ross SM, Schmitz KH, Silva M, Okwuosa T, Washko G, Wisnivesky J, Yankelevitz DF, and Zulueta JJ Journal: Ann Am Thorac Soc

Reducing stigma triggered by assessing smoking status among patients diagnosed with lung cancer: De-stigmatizing do and don’t lessons learned from qualitative interviews. 

Date Published: 2022 Dec Authors: Ostroff JS, Banerjee SC, Lynch K, Shen MJ, Williamson TJ, Haque N, Riley K, Hamann HA, Rigney M, and Park B Journal: PEC Innov

The aim of this study was to characterize lung cancer patients' reactions to cancer care providers' (CCPs) assessment of smoking behavior and to develop recommendations to reduce stigma and improve patient-clinician communication about smoking in the context of lung cancer care. Semi-structured interviews with 56 lung cancer patients (Study 1) and focus groups with 11 lung cancer patients (Study 2) were conducted and analyzed using thematic content analysis. Three broad themes were identified: cursory questions about smoking history and current behavior; stigma triggered by assessment of smoking behavior; and recommended dos and don'ts for CCPs treating patients with lung cancer. CCP communication that contributed to patients' comfort included responding in an empathic manner and using supportive verbal and non-verbal communication skills. Blaming statements, doubting patients' self-reported smoking status, insinuating subpar care, nihilistic statements, and avoidant behaviors contributed to patients' discomfort. Patients often experienced stigma in response to smoking-related discussions with their CCPs and identified several communication strategies that CCPs can use to improve patients' comfort within these clinical encounters. These patient perspectives advance the field by providing specific communication recommendations that CCPs can adopt to mitigate stigma and enhance lung cancer patients' comfort, particularly when taking a routine smoking history.

Identifying barriers to lung cancer advocacy: The role of stigma-related interpersonal constraint.

Date Published: 2022 Oct Authors: Price SN, Shen M, Rigney M, Ostroff JS, and Hamann HA Journal: Oncology Nursing Forum

This study aimed to examine whether aspects of disease-specific stigma are barriers to advocacy among individuals with lung cancer. 266 patients with lung cancer treated at two National Cancer Institute-designated comprehensive cancer centers in the United States. Patients completed a cross-sectional survey. Demographic, clinical, and stigma-related correlates of advocacy were also explored. In multivariable analyses, lower levels of patient advocacy were reported by older patients and those with higher levels of constrained disclosure (i.e., avoidance of or discomfort in disclosing one's lung cancer status). Avoidance of discussing lung cancer (constrained disclosure) may be a barrier to patient involvement in advocacy. Additional research is needed to examine this relationship, reduce stigma, and promote inclusivity for individuals with lung cancer.

Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings.

Date Published: 2022 Aug Authors: Ostroff JS, Shelley DR, Chichester LA, King JC, Li Y, Schofield E, Ciupek A, Criswell A, Acharya R, Banerjee SC, Elkin EB, Lynch K, Weiner BJ, Orlow I, Martin CM, Chan SV, Frederico V, Camille P, Holland S, and Kenney J Journal: Trials

There is widespread agreement that the integration of cessation services in lung cancer screening (LCS) is essential for achieving the full benefits of LCS with low dose computed tomography (LDCT). There is a formidable knowledge gap about how to best design feasible, effective, scalable cessation services in LCS facilities. The Smoking Cessation at Lung Examination (SCALE) Collaboration is a collective of NCI-funded clinical trials addressing this gap. The Cessation and Screening to Save Lives (CASTL) trial seeks to advance knowledge about the reach, effectiveness, and implementation of tobacco treatment in lung cancer screening. We describe the rationale, design, evaluation plan, and interventions tested in this multiphase optimization strategy trial (MOST). A total of 1152 screening-eligible current smokers are being recruited from 18 LCS sites (n = 64/site) in both academic and community settings across the USA. Participants receive enhanced standard care (cessation advice and referral to the national Quitline) and are randomized to receive additional tobacco treatment components (motivational counseling, nicotine replacement patches/lozenges, message framing). The primary outcome is biochemically validated, abstinence at 6 months follow-up. Secondary outcomes are self-reported smoking abstinence, quit attempts, and smoking reduction at 3 and 6 months. Guided by the Implementation Outcomes Framework (IOF), our evaluation includes measurement of implementation processes (reach, fidelity, acceptability, appropriateness, sustainability, and cost). We will identify effective treatment components for delivery by LCS sites. The findings will guide the assembly of an optimized smoking cessation package that achieves superior cessation outcomes. Future trials can examine the strategies for wider implementation of tobacco treatment in LDCT-LCS sites.

Longitudinal COVID-19-vaccination-induced antibody responses and Omicron neutralization in patients with lung cancer.

Date Published: 2022 Apr Authors: Mack PC, Gomez JE, Rodilla AM, Carreño JM, Hsu CY, Rolfo C, Meshulami N, Moore A, Brody RI, King JC, Treatman J, Lee S, Raskin A, Srivastava K, Gleason CR, de Miguel-Perez D; PARIS/PSP study group, Tcheou J, Bielak D, Acharya R, Gerber DE, Rohs N, Henschke CI, Yankelevitz DF, Simon V, Minna JD, Bunn PA Jr, García-Sastre A, Krammer F, Shyr Y, and Hirsch FR Journal: Cancer Cell

Impact of the COVID-19 pandemic on global lung cancer clinical trials: Why it matters to people with lung cancer.

Date Published: 2021 Dec Authors: Roy UB, Baird AM, Ciupek A, Fox J, Manley E Jr, Norris K, Scagliotti GV, Wakelee HA, Mitsudomi T, Clark RC, Arndt R, Hirsch FR, Bunn PA, and Smeltzer MP Journal: JTO Clin Res Rep

Defining comprehensive biomarker-related testing and treatment practices for advanced non-small-cell lung cancer: Results of a survey of U.S. oncologists.

Date Published: 2021 Dec Authors: Mileham KF, Schenkel C, Bruinooge SS, Freeman-Daily J, Basu Roy U, Moore A, Smith RA, Garrett-Mayer E, Rosenthal L, Garon EB, Johnson BE, Osarogiagbon RU, Jalal S, Virani S, Weber Redman M, and Silvestri GA Journal: Cancer Medicine

An ASCO taskforce comprised of representatives of oncology clinicians, the American Cancer Society National Lung Cancer Roundtable (NLCRT), LUNGevity, GO2 for Lung Cancer, and the ROS1ders sought to: characterize U.S. oncologists’ biomarker ordering and treatment practices for advanced non-small-cell lung cancer (NSCLC); ascertain barriers to biomarker testing; and understand the impact of delays on treatment decisions. We deployed a survey to 2374 ASCO members, targeting U.S. thoracic and general oncologists. We analyzed 170 eligible responses. For non-squamous NSCLC, 97% of respondents reported ordering tests for EGFR, ALK, ROS1, and BRAF. Testing for MET, RET, and NTRK was reported to be higher among academic versus community providers and higher among thoracic oncologists than generalists. Most respondents considered 1 (46%) or 2 weeks (52%) an acceptable turnaround time, yet 37% usually waited three or more weeks to receive results. Respondents who waited ≥3 weeks were more likely to defer treatment until results were reviewed (63%). Community and generalist respondents who waited ≥3 weeks were more likely to initiate non-targeted treatment while awaiting results. Respondents <5 years out of training were more likely to cite their concerns about waiting for results as a reason for not ordering biomarker testing (42%, vs. 19% with ≥6 years of experience). Respondents reported high biomarker testing rates in patients with NSCLC. Treatment decisions were impacted by test turnaround time and associated with practice setting and physician specialization and experience.

Lung cancer and severe acute respiratory syndrome coronavirus 2 infection: Identifying important knowledge gaps for investigation.

Date Published: 2021 Nov Authors: Rolfo C, Meshulami N, Russo A, Krammer F, García-Sastre A, Mack PC, Gomez JE, Bhardwaj N, Benyounes A, Sirera R, Moore A, Rohs N, Henschke CI, Yankelevitz D, King J, Shyr Y, Bunn PA Jr, Minna JD, and Hirsch FR Journal: J Thorac Oncol

Patients with lung cancer are especially vulnerable to coronavirus disease 2019 (COVID-19) with a greater than sevenfold higher rate of becoming infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) COVID-19, a greater than threefold higher hospitalization rate with high complication rates, and an estimated case fatality rate of more than 30%. The reasons for the increased vulnerability are not known. In addition, beyond the direct impact of the pandemic on morbidity and mortality among patients with lung cancer, COVID-19, with its disruption of patient care, has also resulted in substantial impact on lung cancer screening and treatment/management.COVID-19 vaccines are safe and effective in people with lung cancer. Based on the available data, patients with lung cancer should continue their course of cancer treatment and get vaccinated against the SARS-CoV-2 virus. For unknown reasons, some patients with lung cancer mount poor antibody responses to vaccination. Thus, boosting vaccination seems urgently indicated in this subgroup of vulnerable patients with lung cancer. Nevertheless, many unanswered questions regarding vaccination in this population remain, including the magnitude, quality, and duration of antibody response and the role of innate and acquired cellular immunities for clinical protection. Additional important knowledge gaps also remain, including the following: how can we best protect patients with lung cancer from developing COVID-19, including managing care in patient with lung cancer and the home environment of patients with lung cancer; are there clinical/treatment demographics and tumor molecular demographics that affect severity of COVID-19 disease in patients with lung cancer; does anticancer treatment affect antibody production and protection; does SARS-CoV-2 infection affect the development/progression of lung cancer; and are special measures and vaccine strategies needed for patients with lung cancer as viral variants of concern emerge.

Knowledge and practice patterns among pulmonologists for molecular biomarker testing in advanced non-small cell lung cancer.

Date Published: 2021 Jun Authors: Fox AH, Jett JR, Roy UB, Johnson BE, King JC, Martin N, Osarogiagbon RU, Rivera MP, Rosenthal LS, Smith RA, and Silvestri GA Journal: Chest Journal

Targeted therapies for advanced non-small cell lung cancer (NSCLC) with oncogenic drivers have caused a paradigm shift in care. Biomarker testing is needed to assess eligibility for these therapies. Pulmonologists often perform bronchoscopy, providing tissue for both pathologic diagnosis and biomarker analysis. We performed this survey to define the existing knowledge and practices regarding the pulmonologists’ role in biomarker testing for advanced NSCLC. This cross-sectional study was performed using an electronic survey of a random sample of 7,238 pulmonologists. Questions focused on diagnostic steps and biomarker analyses for NSCLC. 453 pulmonologists responded. Respondents vary by reported lung cancer patient volume, ranging from 51% evaluating one to four new cases per month to 19% evaluating > 10 cases per month. Interventional training, academic practice setting, and higher volume of endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) were associated with increased knowledge of practice guidelines for the number of recommended passes during EBUS-TBNA (P < .05). Academic pulmonologists more commonly performed or referred for EBUS-TBNA than community pulmonologists (96% and 83%, respectively; P < .0005). Higher testing rates were associated with interventional training, academic setting, and the presence of an institutional policy, whereas lower testing rates were associated with general pulmonologists, practice in community settings, and lack of a guiding institutional policy (P < .05). Substantial differences among pulmonologists’ evaluation of advanced NSCLC, variation in knowledge of available biomarkers and the importance of targeted therapies, and differences in institutional coordination likely lead to underutilization of biomarker testing. Interventional training appears to drive improved knowledge and practice for biomarker testing more than in a practice setting. Improvements are needed in tissue acquisition and interdisciplinary coordination to ensure universal and comprehensive testing for eligible patients.

The Genomics of Young Lung Cancer: comprehensive tissue genomic analysis in patients under 40 with lung cancer.

Date Published: 2021 May Authors: Gitlitz BJ, Novello S, Vavalà T, Bittoni M, Sable-Hunt A, Pavlick D, Hsu R, Park SL, Chen R, Cooke M, Moore A, Schrock AB, Schiller JH, Addario BJ, and Oxnard GR Journal: JTO Clinical and Research Reports

Lung adenocarcinomas in young patients (<40 y) are more likely to harbor targetable genomic alterations. This study aimed to determine whether the prevalence of targetable alterations is greater in young adults with lung carcinoma than in the overall lung cancer population. To reach this rare patient population, a web-based platform was used to recruit and enroll patients remotely. In this prospective study, patients less than 40 years old at the time of primary lung cancer diagnosis with confirmed lung carcinoma were recruited from four global sites and remotely by means of a website. Genotyping data were collected, if available, or obtained by means of next-generation sequencing using the FoundationOne platform. The prevalence of targetable alterations was quantified across patients with advanced adenocarcinoma. Overall, 133 patients across five continents were included, 41% of whom enrolled online. The mean (SD) age at diagnosis was 34 (5.2) years; 79% had stage IV disease at diagnosis. Among patients with adenocarcinoma (n = 115), 112 entered the study with previous genomic testing results and 86 (77%) had targetable alterations in EGFR, ALK, ROS1, MET, ERBB2, or RET. Among those without targetable alterations, 14 received further testing and a targetable alteration was identified in eight (57%). This study revealed the feasibility of using a web-based platform to recruit young patients with lung cancer and revealed that 94 of 112 (84%) with adenocarcinoma at any stage had targetable genomic alterations. Among patients with stage IV adenocarcinoma, 85% had a targetable alteration, which is higher than historical expectations for the general population.

Access to lung cancer screening in the Veterans Health Administration: Does geographic distribution match need in the population?

Date Published: 2021 Feb Authors: Boudreau JH, Miller DR, Qian S, Nunez ER, Caverly TJ, Wiener R Journal: Chest Journal

Studies show uneven access to Medicare-approved lung cancer screening (LCS) programs across the United States. The Veterans Health Administration (VA), the largest national US integrated health system, is potentially well-positioned to coordinate LCS services across regional units to ensure that access matches distribution of need nationally. In this retrospective analysis, we identified LCS examinations in VA facilities between 2013 and 2019 from the VA Corporate Data Warehouse and plotted VA facilities with LCS geographically. We compared estimated LCS rates (unique Veterans screened per LCS-eligible population) across states and VA regional units. Finally, we assessed whether the VA’s new partnership with GO2 for Lung Cancer (which includes more than 750 LCS centers) closes geographic gaps in LCS access. We identified 71,898 LCS examinations in 96 of 139 (69.1%) VA facilities in 44 states between 2013 and 2019, with substantial variation across states (0-8 VA LCS facilities per state). Screening rates among eligible Veterans in the population varied more than 30-fold across regional networks (rate ratio, 33.6; 95% CI, 30.8-36.7 for VA New England vs Veterans Integrated Service Network 4), with weak correlation between eligible populations and LCS rates (coefficient, –0.30). Partnering with GO2 for Lung Cancer expands capacity and access (e.g., all states now have ≥ 1 VA or partner LCS site), but 9 of the 12 states with the highest proportions of rural Veterans still have ≤ 3 total LCS facilities. Disparities in LCS access exist based on where Veterans live, particularly for rural Veterans, even after partnering with the GO2 for Lung Cancer. The nationally integrated VA system has an opportunity to leverage regional resources to distribute and coordinate LCS services better to ensure equitable access.

Responding empathically to patients: a communication skills training module to reduce lung cancer stigma.

Date Published: 2021 Feb Authors: Banerjee SC, Haque N, Bylund CL, Shen MJ, Rigney M, Hamann HA, Parker PA, and Ostroff JS Journal: Transl Behav Med

Most lung cancer patients report perceiving stigma surrounding their diagnosis, and routine clinical interactions with their health care providers (HCPs) are reported as a common source. The adverse effects of lung cancer stigma are associated with several adverse psychosocial and behavioral outcomes. One potential clinician-level intervention target is empathic communication because of its association with higher rates of patients' satisfaction, treatment adherence, and lower levels of psychological distress. This study describes the conceptual model and evaluation of clinician-targeted empathic communication skills training to reduce lung cancer patients' experience of stigma. The goal of the training module is to enhance clinician recognition and responsiveness to lung cancer patients' empathic opportunities by communicating understanding, reducing stigma and distress, and providing support. Thirty multidisciplinary HCPs working in thoracic oncology, thoracic surgery, or pulmonary medicine participated in 2.25 hr. of didactic and experiential training on responding empathically to patients with lung cancer. Overall, participants reported highly favorable evaluations of the training, with at least 90% of participants agreeing or strongly agreeing to 11 of the 12 items assessing clinical relevance, novelty, clarity, and facilitator effectiveness. Participants' self-efficacy to communicate empathically with lung cancer patients increased significantly from pretraining to post training, t(29) = -4.58, p < .001. The empathic communication skills training module was feasible and well received by thoracic and pulmonary medicine HCPs and demonstrated improvements in self-efficacy in empathic communication from pretraining to post training. The examination of patient outcomes is warranted.

SPACEWALK: A remote participation study of ALK resistance leveraging plasma cell-free DNA genotyping.

Date Published: 2021 Feb Authors: Lawrence MN, Tamena RM, Martinez P, Sable-Hunt A, Addario T, Barbour P, Shaffer T, Hosseni SA, Bertucci C, Lim PL, Hong F, Michael K, Simon GR, Reiss JW, Award MM, and Oxnard G Journal: JTO Clinical and Research Reports

Remote consent and enrollment offer a unique opportunity to provide rare cancer populations with access to clinical research. The genomic analysis of plasma cell-free DNA (cfDNA) permits remote characterization of the cancer genome. We hypothesized we could leverage these approaches to remotely study drug resistance in patients with metastatic ALK-positive NSCLC. The SPACEWALK study (Study of Plasma Next-Generation Sequencing for Remote Assessment, Characterization, Evaluation of Patients with ALK Drug Resistance) enrolled patients with ALK-positive NSCLC and progression on a next-generation ALK inhibitor who could participate remotely. Plasma was collected for next-generation sequencing (NGS) of cfDNA before initiating subsequent therapy, with results returned and subsequent therapy studied. Of the 62 patients enrolled, an ALK fusion was detected in 27 (44%) with a median allelic fraction of 2.6%. Among these 27 patients, a potential resistance mechanism was identified in 17 patients (63%): eight cases (30%) had secondary ALK kinase domain resistance mutations, three cases (11%) had bypass track resistance, and six cases (22%) had both ALK resistance mutations and bypass resistance. The most frequently detected mechanism of bypass resistance was MET amplification. Repeat plasma NGS was performed in 14 patients after subsequent treatment was initiated, with seven (50%) patients exhibiting greater than 50% reductions in ALK fusion allelic fraction. Through the leveraging of remote participation, plasma NGS offers an optimal mechanism for characterizing resistance to emerging targeted therapies in rare cancer populations, though sensitivity depends on adequate tumor DNA samples. Repeat cfDNA analysis on therapy may offer an objective monitoring approach to remotely study treatment response.

Use of a cancer registry to evaluate patient-reported outcomes of immune checkpoint inhibitors.

Date Published: 2020 Dec Authors: Jim HSL, Eisel SL, Hoogland AI, Shaw S, King JC, and Dicker AP Journal: Cancers (Basel)

Immune checkpoint inhibitors (ICIs) are increasingly used for advanced lung cancer, but few studies have reported on patient-reported outcomes (PROs) outside the context of a clinical trial. The goal of the current study was to assess PROs in patients participating in GO2 for Lung Cancer’s Lung Cancer Registry who reported receiving atezolizumab, durvalumab, nivolumab, or pembrolizumab. Internationally, 226 patients (mean age 61, 75% female) participated. Patients reported worse quality of life than U.S. population and cancer normative samples. The most common moderate to severe adverse events during ICI treatment were fatigue (41%), aching joints (27%), and aching muscles (20%). Due to toxicity, 25% reported a treatment delay, 11% an emergency room visit, and 9% a hospitalization. This study is among the first to our knowledge to report on PROs of ICIs outside the context of a clinical trial. Results suggest higher rates of adverse events than previously reported in clinical trials.

Oncology care provider training in empathic communication skills to reduce lung cancer stigma.

Date Published: 2020 Dec Authors: Banerjee SC, Haque N, Schofield EA, Williamson TJ, Martin CM, Bylund CL, Shen MJ, Rigney M, Hamann HA, Parker PA, McFarland DC, Park BJ, Molena D, Moreno A, and Ostroff JS Journal: Chest Journal

Despite the clinical importance of assessing smoking history and advising patients who smoke to quit, patients with lung cancer often experience feelings of blame and stigma during clinical encounters with their oncology care providers (OCPs). Promoting empathic communication during these encounters may help reduce patients’ experience of stigma and improve related clinical outcomes. This paper presents the evaluation of OCP- and patient-reported data on the usefulness of an OCP-targeted empathic communication skills (ECS) training to reduce the stigma of lung cancer and improve communication. Study subjects included 30 multidisciplinary OCPs treating patients with lung cancer who participated in a 2.25 h ECS training. Standardized Patient Assessments were conducted prior to and following training to assess ECS uptake among OCPs. In addition, of a planned 180 patients who currently or formerly smoked (six unique patients per OCP [three pretraining, three post training]), 175 patients (89 pretraining, 86 post training) completed post-OCP visit surveys eliciting feedback on the quality of their interaction with their OCP. OCPs exhibited an overall increase in use of empathic communication skills [t(28) = –2.37; P < .05], stigma-mitigating skills [t(28) = –3.88; P < .001], and breadth of communication skill use [t(28) = –2.91; P < .01]. Patients reported significantly higher overall satisfaction with communication post-ECS training, compared with pretraining [t(121) = 2.15; P = .034; Cohen d = 0.35]. There were no significant differences from pretraining to post training for patient-reported stigma or perceived OCP empathy. Empathy-based, stigma-reducing communication may lead to improved assessments of tobacco use and smoking cessation for patients with smoking-related cancers. These findings support the dissemination and further testing of a new ECS model for training OCPs in best practices for assessment of smoking history and engagement of patients who currently smoke in tobacco treatment delivery.

A 10-year cross-sectional analysis of public, oncologist, and patient attitudes about lung cancer and associated stigma.

Date Published: 2020 Oct Authors: Rigney M, Rapsomaniki E, Carter-Harris L, and King JC Journal: J Thorac Oncol

Lung cancer stigma negatively impacts the clinical care and outcomes of those diagnosed, resulting in enduring disparities. The objective of this study was to determine whether attitudes toward lung cancer and the stigmatization of people diagnosed have changed over a decade. A cross-sectional survey was administered to the general public, oncologists, and people with lung cancer 10 years apart (2008 and 2018) using the same instrument and methodology. The measures of stigma agreement ratings on a five-point Likert scale were compared between 2008 and 2018 for all three sample groups. In 2018, a total of 1001 members of the general public, 205 oncologists, and 208 people with lung cancer were enrolled. Improvements were noted over the decade, including the availability of more treatment options. Greater disease awareness was also found, with 94% of the public reporting knowledge of lung cancer (versus 82.5% in 2008, p < 0.0001). However, no change was found in the percentage of the public reporting that patients with lung cancer are at least partially to blame for their illness (60.3% in 2018). In 2018, more people with lung cancer agreed there is a stigma associated with lung cancer (72.1 versus 54.5%, p < 0.001) and that those diagnosed are viewed or treated differently by society in general (69.4% versus 50.8%, p < 0.001). The results reflect recognition of treatment gains and increased visibility of lung cancer but also highlight that stigma remains a significant problem. Of critical importance to the care of those diagnosed was the unexpected increase in stigma reported by the patient population.

An examination of two dichotomies: Women with lung cancer and living with lung cancer as a chronic disease.

Date Published: 2020 Oct Authors: Vavala T, Rigney M, Reale ML, Novello S, and King JC Journal: Respirology

Lung cancer remains the leading cause of cancer death globally, yet with many recent advances in the diagnosis and treatment of lung cancer, the face of the disease is shifting. Historically, lung cancer is often thought of as a predominantly male disease with more than twice as many men as women being diagnosed worldwide—mostly due to the influence of smoking as the leading risk factor. However, lung cancer is also the second leading cause of cancer death in women and there is a growing population of young women who have never smoked and are being diagnosed. The past decade has seen groundbreaking innovations in both the early detection and treatment of lung cancer. In this new era, survival rates are beginning to increase and many of those diagnosed are finding themselves in a new situation—living long term with a deadly cancer. Here, we review pertinent aspects of women and lung cancer as well as the concept of living with lung cancer as a chronic disease to give a new perspective on the changing face of lung cancer treatment and care.

Characteristics of patients with ROS1+ cancers: Results from the first patient-designed, global, pan-cancer ROS1 data repository.

Date Published: 2020 Feb Authors: Parikh DA, Walia G, Freeman-Daily J, Hennink M, Tomalia T, Buonanno L, Goldman L, Addario B, and Patel MI Journal: JCO Oncol Pract

The discovery of driver oncogenes, such as ROS1, has led to the development of targeted therapies. Despite clinical advancements, gaps remain in our understanding of the characteristics of patients with ROS1-positive (ROS1+) cancers. The purpose of this study was to comprehensively assess demographic, clinical, and environmental characteristics associated with ROS1+ cancers worldwide. In collaboration with a panel of patients with ROS1+ cancer, we designed and conducted a 204-question online assessment regarding the demographic, clinical, and environmental factors of patients with ROS1+ cancers. We invited patients with ROS1+ cancers to participate in the study from May 2016 to December 2018. A total of 277 patients from 18 countries worldwide responded and completed at least 90% of the survey. The majority of respondents were female (n = 191; 69%), non-Hispanic white (n = 202; 73%), and never-smokers (n = 180/240; 75%). Most were diagnosed with lung cancer (n = 261/277; 94%) and stage IV disease (n = 201/277; 76%). The majority received chemotherapy in the first (n = 137/199; 69%) and second (n = 103/199; 52%) lines of therapy. For patients diagnosed with lung cancer after the availability of crizotinib (n = 199), only a minority (n = 55/199; 28%) reported receiving crizotinib in the first line of therapy. This study is the first global, patient-designed approach to our knowledge to comprehensively assess demographic, clinical, and environmental characteristics associated with ROS1+ cancers. Future efforts include assessing these characteristics, patient-reported outcomes and treatment responses longitudinally.

The International Association for the Study of Lung Cancer Early Lung Imaging Confederation.

Date Published: 2020 Feb Authors: Mulshine JL, Avila RS, Conley E, Devaraj A, Ambrose LF, Flanagan T, Henschke CI, Hirsch FR, Janz R, Kakinuma R, Lam S, McWilliams A, Van Ooijen PMA, Oudkerk M, Pastorino U, Reeves A, Rogalla P, Schmidt H, Sullivan DC, Wind HHJ, Wu N, Wynes M, Xueqian X, Yankelevitz DF, and Field JK Journal: JCO Clin Cancer Inform

This study aims to improve outcomes for lung cancer through low dose computed tomography (LDCT) early lung cancer detection. The International Association for the Study of Lung Cancer is developing the Early Lung Imaging Confederation (ELIC) to serve as an open-source, international, universally accessible environment to analyze large collections of quality-controlled LDCT images and associated biomedical data for research and routine screening care. The goal of pilot experiments is to connect image collections of LDCT scans that can be accurately analyzed in a fashion to support a global network using methodologies that can be readily scaled to accrued databases of sufficient size to develop and validate robust quantitative imaging tools. This initiative can rapidly accelerate improvements to the multidisciplinary management of early, curable lung cancer and other major thoracic diseases (e.g., coronary artery disease and chronic obstructive pulmonary disease) visualized on a screening LDCT scan. The addition of a facile, quantitative CT scanner image quality conformance process is a unique step toward improving the reliability of clinical decision support with CT screening worldwide. 

Including the patient voice in the development and implementation of patient‐reported outcomes in cancer clinical trials

Date Published: 2020 Feb Authors: Addario B, Geissler J, Horn MK, Krebs LU, Maskens D, Oliver K, Plate A, Schwartz E, and Willmarth N Journal: Health Expect

Patient-reported outcomes (PROs) are used in parallel with clinical evidence to inform decisions made by industry, clinicians, regulators, health technology assessment bodies, and other healthcare decision-makers. In addition, PRO data can also guide shared decision-making and individual patient choice. Yet, the quality of many PROs in cancer clinical trials is suboptimal and requires improvement to add value to health care and policy decision-making. We examined the literature to show that the patient voice is often absent from the planning and implementation of PROs in cancer clinical trials. Good practice examples from the literature were combined with guideline recommendations, training or educational resources, and our own experience to create detailed practical steps for the inclusion of patients and/or patient advocates throughout PRO development. Patient or patient advocates can play an active role in shaping PROs that are meaningful to the patient. They can contribute to content, choice of medium and implementation in a way that may support PRO completion and minimize missing data. Patients and their advocates can work to ensure PRO findings are disseminated appropriately in a way that is accessible to patients. This practical guidance aims to optimize PRO development and implementation in clinical trials, resulting in robust, relevant data reflecting and supporting the patient experience and that support decisions made by all stakeholders involved in research and health care.

Effectiveness of lung cancer screening implementation in the community setting in the United States

Date Published: 2019 May Authors: Copeland A, Criswell A, Ciupek A, and King JC Journal: J Oncol Pract

The National Lung Screening Trial demonstrated a 20% relative reduction in lung cancer mortality with low-dose computed tomography (CT) screening, leading to the implementation of lung cancer screening across the United States. The Centers for Medicare and Medicaid Services approved coverage, but questions remained about the effectiveness of community-based screening. To assess screening implementation during the first full year of CMS coverage, we surveyed a nationwide network of lung cancer screening centers, comparing results from academic and nonacademic centers. Centers were predominantly community-based (62%), with broad geographic distribution. In both community and academic centers, more than half of lung cancers were diagnosed at stage I or limited stage, demonstrating a clear stage shift compared with historical data. Lung-RADS results were also comparable. There are wide variations in the ways centers address Centers for Medicare and Medicaid Services requirements. The most significant barriers to screening implementation were insurance and billing issues, lack of provider referral, lack of patient awareness, and internal workflow challenges. These data validate that responsible screening can take place in a community setting and that lung cancers detected by low-dose computed tomography screening are often diagnosed at an early, more treatable stage. Lung cancer screening programs have developed different ways to address requirements, but many implementation challenges remain.