Publications by authors named "Graham W Warren"

91 Publications

Associations between cancer diagnosis and patients' responses to an inpatient tobacco treatment intervention.

Cancer Med 2021 Aug 1;10(15):5329-5337. Epub 2021 Jul 1.

Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.

Background: Diagnosis of a chronic illness, such as cancer may influence health behavior changes, such as smoking cessation. The present analyses examine associations between a cancer diagnosis (i.e., yes or no) and response to an opt-out smoking cessation bedside intervention provided to hospitalized patients. It was hypothesized that patients with a past or present cancer diagnosis would report higher motivation and engagement with quitting smoking, and higher rates of smoking abstinence after hospital discharge, compared to those without a cancer diagnosis.

Methods: Chart review was conducted on 5287 inpatients who accepted bedside treatment from a counselor and opted-in to automated follow-up calls from July 2014 to December 2019.

Results: At the time of inpatient assessment, those with a past or present cancer diagnosis (n = 419, 7.9%) endorsed significantly higher levels of importance of quitting than those without a cancer diagnosis (3.92/5 vs. 3.77/5), and were more likely to receive smoking cessation medication upon discharge (17.9% vs. 13.3%). Follow-up data from 30-days post-discharge showed those with a cancer diagnosis endorsed higher rates of self-reported abstinence (20.5%) than those without a cancer diagnosis (10.3%; p < 0.001).

Conclusion: Being hospitalized for any reason provides an opportunity for smokers to consider quitting. Having a previous diagnosis of cancer appears to increase intention to quit and lead to higher rates of smoking cessation in patients who are hospitalized compared to patients without cancer. Future research needs to work toward optimizing motivation for smoking cessation while admitted to a hospital and on improving quit rates for all admitted patients, regardless of diagnosis.
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http://dx.doi.org/10.1002/cam4.4082DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8335828PMC
August 2021

Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial.

BMJ Open 2021 06 29;11(6):e051226. Epub 2021 Jun 29.

Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.

Introduction: Continued smoking following a cancer diagnosis has substantial health risks including increased overall and cancer-specific mortality, risk of secondary malignancies, cancer treatment toxicity and risk of surgical complications. These risks can be mitigated by quitting smoking. The preoperative period represents a prime opportunity in which to administer robust smoking cessation treatment to both improve health and support and improve surgical outcomes. We will conduct a randomised clinical trial to evaluate the effectiveness of financial incentives delivered contingent on biochemically verified smoking abstinence (contingency management (CM)) in patients with cancer undergoing surgery.

Methods And Analysis: The study will take place across two study sites, and participants (N=282) who smoke, are diagnosed with or suspected to have any type of operable cancer and have a surgical procedure scheduled in the next 10 days to 5 weeks will be randomised to receive standard care plus Monitoring Only or CM prior to surgery. All patients will receive breath carbon monoxide (CO) tests three times per week, nicotine replacement therapy and counselling. The CM group will also earn payments for self-reported smoking abstinence confirmed by CO breath test ≤4 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Point prevalence abstinence (PPA) outcomes (self-report of 7-day abstinence confirmed by CO≤4 ppm and/or anabasine ≤2 ng/mL) will be assessed on the day of surgery and 6 months after surgery. The effect of CM on 7-day PPA at the time of surgery and 6-month follow-up will be modelled using generalised linear mixed effects models.

Ethics And Dissemination: This study has been reviewed and approved by the Medical University of South Carolina Institutional Review Board. We will disseminate our scientific results through traditional research-oriented outlets such as presentations at scientific meetings and publications in peer-reviewed journals.

Trial Registration Number: NCT04605458.
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http://dx.doi.org/10.1136/bmjopen-2021-051226DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8245459PMC
June 2021

New Pulmonary Infiltrates Observed on Computed Tomography-Based Image Guidance for Radiotherapy Warrant Diagnostic Workup for Coronavirus Disease 2019.

J Thorac Oncol 2021 Jun 22. Epub 2021 Jun 22.

Department of Oncology and Pharmacology, Mayo Clinic, Rochester, Minnesota.

Introduction: Screening for coronavirus disease 2019 (COVID-19) exposure, coupled with engaged decision making to prioritize cancer treatment in parallel with reducing risk of exposure and infection, is crucial in the management of COVID-19 during cancer treatment. After two reported case studies of imaging findings during daily computed tomography (CT)-based image-guided radiotherapy (RT) scans, a call for submission of anonymized case reports was published with the objective of rapidly determining if there was a correlation between the onset of new pulmonary infiltrates found during RT and COVID-19. We hereby report the results of the aggregate analysis.

Methods: Data of deidentified case reports for patients who developed biochemically confirmed COVID-19 during RT were submitted through an online portal. Information requested included a patient's sex, age, cancer diagnosis and treatment, and COVID-19 diagnosis and outcome. Coplanar CT-based imaging was requested to reveal the presence or absence of ground-glass opacities or infiltrates.

Results: A total of seven reports were submitted from Turkey, Spain, Belgium, Egypt, and the United States. Results and imaging from the patients reported by Suppli et al. and McGinnis et al. were included for a total of nine patients for analysis. All patients were confirmed COVID-19 positive using polymerase chain reaction-based methods or nasopharyngeal swabs. Of the nine patients analyzed, abnormalities consistent with ground-glass opacities or infiltrates were observed in eight patients.

Conclusions: This is the largest case series revealing the potential use of CT-based image guidance during RT as a tool for identifying patients who need further workup for COVID-19. Considerations for reviewing image guidance for new pulmonary infiltrates and immediate COVID-19 testing in patients who develop new infiltrates even without COVID-19 symptoms are strongly encouraged.
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http://dx.doi.org/10.1016/j.jtho.2021.06.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8216849PMC
June 2021

Concordance Between Electronic Health Record and Tumor Registry Documentation of Smoking Status Among Patients With Cancer.

JCO Clin Cancer Inform 2021 05;5:518-526

Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL.

Purpose: Patients with cancer who use tobacco experience reduced treatment effectiveness, increased risk of recurrence and mortality, and diminished quality of life. Accurate tobacco use documentation for patients with cancer is necessary for appropriate clinical decision making and cancer outcomes research. Our aim was to assess agreement between electronic health record (EHR) smoking status data and cancer registry data.

Materials And Methods: We identified all patients with cancer seen at University of Florida Health from 2015 to 2018. Structured EHR smoking status was compared with the tumor registry smoking status for each patient. Sensitivity, specificity, positive predictive values, negative predictive values, and Kappa statistics were calculated. We used logistic regression to determine if patient characteristics were associated with odds of agreement in smoking status between EHR and registry data.

Results: We analyzed 11,110 patient records. EHR smoking status was documented for nearly all (98%) patients. Overall kappa (0.78; 95% CI, 0.77 to 0.79) indicated moderate agreement between the registry and EHR. The sensitivity was 0.82 (95% CI, 0.81 to 0.84), and the specificity was 0.97 (95% CI, 0.96 to 0.97). The logistic regression results indicated that agreement was more likely among patients who were older and female and if the EHR documentation occurred closer to the date of cancer diagnosis.

Conclusion: Although documentation of smoking status for patients with cancer is standard practice, we only found moderate agreement between EHR and tumor registry data. Interventions and research using EHR data should prioritize ensuring the validity of smoking status data. Multilevel strategies are needed to achieve consistent and accurate documentation of smoking status in cancer care.
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http://dx.doi.org/10.1200/CCI.20.00187DOI Listing
May 2021

Mixed-methods economic evaluation of the implementation of tobacco treatment programs in National Cancer Institute-designated cancer centers.

Implement Sci Commun 2021 Apr 9;2(1):41. Epub 2021 Apr 9.

University of Wisconsin Carbone Cancer Center, Madison, WI, USA.

Background: The Cancer Center Cessation Initiative (C3I) was launched in 2017 as a part of the NCI Cancer Moonshot program to assist NCI-designated cancer centers in developing tobacco treatment programs for oncology patients. Participating centers have implemented varied evidence-based programs that fit their institutional resources and needs, offering a wide range of services including in-person and telephone-based counseling, point of care, interactive voice response systems, referral to the quitline, text- and web-based services, and medications.

Methods: We used a mixed methods comparative case study design to evaluate system-level implementation costs across 15 C3I-funded cancer centers that reported for at least one 6-month period between July 2018 and June 2020. We analyzed operating costs by resource category (e.g., personnel, medications) concurrently with transcripts from semi-structured key-informant interviews conducted during site visits. Personnel salary costs were estimated using Bureau of Labor Statistics wage data adjusted for area and occupation, and non-wage benefits. Qualitative findings provided additional information on intangible resources and contextual factors related to implementation costs.

Results: Median total monthly operating costs across funded centers were $11,045 (range: $5129-$20,751). The largest median operating cost category was personnel ($10,307; range: $4122-$19,794), with the highest personnel costs attributable to the provision of in-person program services. Monthly (non-zero) cost ranges for other categories were medications ($17-$573), materials ($6-$435), training ($96-$516), technology ($171-$2759), and equipment ($10-$620). Median cost-per-participant was $466 (range: $70-$2093) and cost-per-quit was $2688 (range: $330-$9628), with sites offering different combinations of program components, ranging from individually-delivered in-person counseling only to one program that offered all components. Site interviews provided context for understanding variations in program components and their cost implications.

Conclusions: Among most centers that have progressed in tobacco treatment program implementation, cost-per-quit was modest relative to other prevention interventions. Although select centers have achieved similar average costs by offering program components of various levels of intensity, they have varied widely in program reach and effectiveness. Evaluating implementation costs of such programs alongside reach and effectiveness is necessary to provide decision makers in oncology settings with the important additional information needed to optimize resource allocation when establishing tobacco treatment programs.
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http://dx.doi.org/10.1186/s43058-021-00144-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8033545PMC
April 2021

Development and Evaluation of a Navigation-Based, Multilevel Intervention to Improve the Delivery of Timely, Guideline-Adherent Adjuvant Therapy for Patients With Head and Neck Cancer.

JCO Oncol Pract 2021 Oct 10;17(10):e1512-e1523. Epub 2021 Mar 10.

Hollings Cancer Center, Medical University of South Carolina, Charleston, SC.

Purpose: More than half of patients with head and neck squamous cell carcinoma (HNSCC) experience a delay initiating guideline-adherent postoperative radiation therapy (PORT), contributing to excess mortality and racial disparities in survival. However, interventions to improve the delivery of timely, equitable PORT among patients with HNSCC are lacking. This study (1) describes the development of NDURE (Navigation for Disparities and Untimely Radiation thErapy), a navigation-based multilevel intervention (MLI) to improve guideline-adherent PORT and (2) evaluates its feasibility, acceptability, and preliminary efficacy.

Methods: NDURE was developed using the six steps of intervention mapping (IM). Subsequently, NDURE was evaluated by enrolling consecutive patients with locally advanced HNSCC undergoing surgery and PORT (n = 15) into a single-arm clinical trial with a mixed-methods approach to process evaluation.

Results: NDURE is a navigation-based MLI targeting barriers to timely, guideline-adherent PORT at the patient, healthcare team, and organizational levels. NDURE is delivered via three in-person navigation sessions anchored to case identification and surgical care transitions. Intervention components include the following: (1) patient education, (2) travel support, (3) a standardized process for initiating the discussion of expectations for PORT, (4) PORT care plans, (5) referral tracking and follow-up, and (6) organizational restructuring. NDURE was feasible, as judged by accrual (88% of eligible patients [100% Blacks] enrolled) and dropout (n = 0). One hundred percent of patients reported moderate or strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for Black patients.

Conclusion: NDURE is a navigation-based MLI that is feasible, is acceptable, and has the potential to improve the timely, equitable, guideline-adherent PORT.
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http://dx.doi.org/10.1200/OP.20.00943DOI Listing
October 2021

Cost evaluation of tobacco control interventions in clinical settings: A systematic review.

Prev Med 2021 05 24;146:106469. Epub 2021 Feb 24.

Department of Cell and Molecular Pharmacology, Medical University of South Carolina, Charleston, SC, USA; Department of Radiation Oncology, Medical University of South Carolina, Charleston, SC, USA.

Elucidating the cost implications of tobacco control interventions is a prerequisite to their adoption in clinical settings. This review fills a knowledge gap in characterizing the extent to which cost is measured in tobacco control studies. A search of English literature was conducted in the following electronic databases: MEDLINE, EconLit, PsychINFO, and CINAHL using MeSH terms from 2009 to 2018. Studies were reviewed by two independent reviewers and included if they were conducted in U.S. inpatient or outpatient facilities and reported costs associated with a tobacco control intervention. They were categorized according to evaluation type, clinical setting, target population, cost measures, and stakeholder perspective. Bias risk was evaluated for RCTs. Seventeen publications were included, representing counseling interventions (n = 8) and combination (i.e., counseling and pharmacotherapy) interventions (n = 9). Studies were categorized by evaluation type: cost-effectiveness analysis (n = 10), cost utility analysis (n = 3) and cost identification (n = 4). The selected studies targeted the following populations: general adults (n = 6), hospitalized/inpatient (n = 4), military/veterans (n = 4), individuals with low socioeconomic status (n = 4), mental health or medical comorbidities (n = 2), and pregnant women (n = 2). Intervention costs included personnel, medication, education material, technology, and overhead costs. Stakeholder perspectives included: healthcare organization (n = 10), payer (n = 8), patient (n = 2), and societal (n = 1). Few studies have reported the cost of tobacco control interventions in clinical settings. Cost is a critical outcome that should be consistently measured in evaluations of tobacco control interventions to promote their uptake in clinical settings.
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http://dx.doi.org/10.1016/j.ypmed.2021.106469DOI Listing
May 2021

Tobacco Use and Treatment among Cancer Survivors.

Int J Environ Res Public Health 2020 12 6;17(23). Epub 2020 Dec 6.

Department of Family Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.

Tobacco use is causally associated with the risk of developing multiple health conditions, including over a dozen types of cancer, and is responsible for 30% of cancer deaths in the U [...].
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http://dx.doi.org/10.3390/ijerph17239109DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7730918PMC
December 2020

Negative affect and the utilization of tobacco treatment among adult smokers with cancer.

Psychooncology 2021 01 15;30(1):93-102. Epub 2020 Sep 15.

Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, Florida, USA.

Objective: We investigated the patterns of tobacco treatment utilization among US adult smokers with cancer and the role of negative affect as potential individual-level psychosocial barriers and facilitators influencing quit attempts and tobacco treatment utilization.

Methods: We analyzed data from the adult sample in Wave 1 (2013-2014) of the Population Assessment of Tobacco and Health (PATH) Study. Using structural equation modeling, we examined (1) the association between cancer diagnosis and negative affect (e.g., depressive mood, anxiety, and distress) and (2) the associations between negative affect and smoking cessation behaviors (i.e., quit attempts and tobacco treatment utilization).

Results: Compared to adults without cancer, cancer survivors were more likely to have attempted to quit tobacco use in the past 12 months (p < 0.05) and experienced increased negative affect (p < 0.01). However, negative affect appeared to be a psychological barrier to quit attempts, as it was associated with lower likelihood of attempting to quit (p < 0.05). On the other hand, among past-12-month quit attempters, negative affect was related to higher likelihood of using any type of tobacco treatment (p < 0.001).

Conclusions: Negative affect may be a potential underlying mechanism in the relationship between cancer diagnosis status and quit attempts and tobacco treatment utilization, influencing the utilization of tobacco treatment among smokers with cancer. Research is needed to investigate whether integrating emotional management in the oncology setting may effectively aid smoking cessation among patients with cancer.
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http://dx.doi.org/10.1002/pon.5543DOI Listing
January 2021

European practice patterns and barriers to smoking cessation after a cancer diagnosis in the setting of curative versus palliative cancer treatment.

Eur J Cancer 2020 10 29;138:99-108. Epub 2020 Aug 29.

Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address:

Background: Smoking cessation after a cancer diagnosis is associated with improved overall survival. Few studies have reported oncologists' cessation practice patterns, but differences between the curative and palliative settings have not been described. We aimed to study the oncologist's perceptions on patients' tobacco use, current practices and barriers to providing smoking cessation support, while distinguishing between treatment with curative (C) and palliative (P) intent.

Methods: In 2019, an online 34-item survey was sent to approximately 6235 oncologists from 16 European countries. Responses were descriptively reported and compared by treatment setting.

Results: Responses from 544 oncologists were included. Oncologists appeared to favour addressing tobacco in the curative setting more than in the palliative setting. Oncologists believe that continued smoking impacts treatment outcomes (C: 94%, P: 74%) and that cessation support should be standard cancer care (C: 95%, P: 63%). Most routinely assess tobacco use (C: 93%, P: 78%) and advise patients to stop using tobacco (C: 88%, P: 54%), but only 24% (P)-39% (C) routinely discuss medication options, and only 18% (P)-31% (C) provide cessation support. Hesitation to remove a pleasurable habit (C: 13%, P: 43%) and disbelieve on smoking affecting outcomes (C: 3%, P: 14%) were disparate barriers between the curative and palliative settings (p < 0.001), but dominant barriers of time, resources, education and patient resistance were similar between settings.

Conclusion: Oncologists appear to favour addressing tobacco use more in the curative setting; however, they discuss medication options and/or provide cessation support in a minority of cases. All patients who report current smoking should have access to evidence-based smoking cessation support, also patients treated with palliative intent given their increasing survival.
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http://dx.doi.org/10.1016/j.ejca.2020.07.020DOI Listing
October 2020

Barriers to the Delivery of Timely, Guideline-Adherent Adjuvant Therapy Among Patients With Head and Neck Cancer.

JCO Oncol Pract 2020 12 27;16(12):e1417-e1432. Epub 2020 Aug 27.

Hollings Cancer Center, Medical University of South Carolina, Charleston, SC.

Purpose: Delays initiating guideline-adherent postoperative radiation therapy (PORT) in head and neck squamous cell carcinoma (HNSCC) are common, contribute to excess mortality, and are a modifiable target for improving survival. However, the barriers that prevent the delivery of timely, guideline-adherent PORT remain unknown. This study aims to identify the multilevel barriers to timely, guideline-adherent PORT and organize them into a conceptual model.

Materials And Methods: Semi-structured interviews with key informants were conducted with a purposive sample of patients with HNSCC and oncology providers across diverse practice settings until thematic saturation (n = 45). Thematic analysis was performed to identify the themes that explain barriers to timely PORT and to develop a conceptual model.

Results: In all, 27 patients with HNSCC undergoing surgery and PORT were included, of whom 41% were African American, and 37% had surgery and PORT at different facilities. Eighteen clinicians representing a diverse mix of provider types from 7 oncology practices participated in key informant interviews. Five key themes representing barriers to timely PORT were identified across 5 health care delivery levels: (1) inadequate education about timely PORT, (2) postsurgical sequelae that interrupt the tight treatment timeline (both intrapersonal level), (3) insufficient coordination and communication during care transitions (interpersonal and health care team levels), (4) fragmentation of care across health care organizations (organizational level), and (5) travel burden for socioeconomically disadvantaged patients (community level).

Conclusion: This study provides a novel description of the multilevel barriers that contribute to delayed PORT. Interventions targeting these multilevel barriers could improve the delivery of timely, guideline-adherent PORT and decrease mortality for patients with HNSCC.
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http://dx.doi.org/10.1200/OP.20.00271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7735037PMC
December 2020

Pragmatic Application of the RE-AIM Framework to Evaluate the Implementation of Tobacco Cessation Programs Within NCI-Designated Cancer Centers.

Front Public Health 2020 12;8:221. Epub 2020 Jun 12.

Department of Medicine, Center for Tobacco Research and Intervention, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI, United States.

Tobacco cessation after cancer diagnosis leads to better patient outcomes. However, tobacco treatment services are frequently unavailable in cancer care settings, and multilevel implementation challenges can impede uptake of new programs. The National Cancer Institute (NCI) dedicated Cancer Moonshot funding through the Cancer Center Cessation Initiative (C3I) for NCI-Designated Cancer Centers to implement or enhance the implementation of tobacco treatment services. We examined a pragmatic application of the RE-AIM framework (reach, effectiveness, adoption, implementation, and maintenance) to evaluate tobacco treatment programs implemented within Cancer Centers funded through C3I. Using three C3I-funded Centers as examples, we describe how each RE-AIM construct was operationalized to evaluate the implementation of a wide range of cessation services (e.g., tobacco use screening, counseling, Quitline referral, pharmacotherapy) in this heterogeneous group of cancer care settings. We discuss the practical challenges encountered in assessing RE-AIM constructs in real world situations, including using the electronic health record (EHR) to aid in assessment. Reach and effectiveness evaluation required that Centers define the setting(s) where cessation services were implemented (to determine the "denominator"), enumerate the patient population, report current patient tobacco use, patient engagement in tobacco treatment, and 6-month cessation outcomes. To reduce site heterogeneity, increase data accuracy, and reduce burden, reach was frequently captured via standardized EHR enhancements that improved the identification of current smokers and tobacco treatment referrals. Effectiveness was determined by cessation outcomes (30-day point prevalence abstinence at 6-months post-engagement) assessed through a variety of data collection approaches. Adoption was measured by the characteristics and proportion of targeted cancer care settings and clinicians engaged in cessation service delivery. Implementation was assessed by examining the delivery of tobacco screening assessments and intervention components across sites, and provider-level implementation consistency. Maintenance assessments identified whether tobacco treatment services continued in the setting after implementation and documented the sustainability plan and organizational commitment to continued delivery. In sum, this paper demonstrates a pragmatic approach to using RE-AIM as an evaluation framework that yields relevant outcomes on common implementation metrics across widely differing tobacco treatment approaches and settings.
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http://dx.doi.org/10.3389/fpubh.2020.00221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304341PMC
May 2021

Smoking-Cessation Methods and Outcomes Among Cancer Survivors.

Am J Prev Med 2020 10 21;59(4):615-617. Epub 2020 May 21.

Department of Radiation Oncology and Department of Cell and Molecular Pharmacology, Medical University of South Carolina, Charleston, South Carolina.

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http://dx.doi.org/10.1016/j.amepre.2020.03.016DOI Listing
October 2020

Treatment Guidance for Patients With Lung Cancer During the Coronavirus 2019 Pandemic.

J Thorac Oncol 2020 07 15;15(7):1119-1136. Epub 2020 May 15.

Department of Medicine, Penn State Cancer Institute, Hershey, Pennsylvania. Electronic address:

The global coronavirus disease 2019 pandemic continues to escalate at a rapid pace inundating medical facilities and creating substantial challenges globally. The risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in patients with cancer seems to be higher, especially as they are more likely to present with an immunocompromised condition, either from cancer itself or from the treatments they receive. A major consideration in the delivery of cancer care during the pandemic is to balance the risk of patient exposure and infection with the need to provide effective cancer treatment. Many aspects of the SARS-CoV-2 infection currently remain poorly characterized and even less is known about the course of infection in the context of a patient with cancer. As SARS-CoV-2 is highly contagious, the risk of infection directly affects the cancer patient being treated, other cancer patients in close proximity, and health care providers. Infection at any level for patients or providers can cause considerable disruption to even the most effective treatment plans. Lung cancer patients, especially those with reduced lung function and cardiopulmonary comorbidities are more likely to have increased risk and mortality from coronavirus disease 2019 as one of its common manifestations is as an acute respiratory illness. The purpose of this manuscript is to present a practical multidisciplinary and international overview to assist in treatment for lung cancer patients during this pandemic, with the caveat that evidence is lacking in many areas. It is expected that firmer recommendations can be developed as more evidence becomes available.
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http://dx.doi.org/10.1016/j.jtho.2020.05.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227539PMC
July 2020

Development and Validation of Nomograms for Predicting Delayed Postoperative Radiotherapy Initiation in Head and Neck Squamous Cell Carcinoma.

JAMA Otolaryngol Head Neck Surg 2020 05;146(5):455-464

Department of Otolaryngology-Head & Neck Surgery, Medical University of South Carolina, Charleston.

Importance: The standard of care for initiation of postoperative radiotherapy (PORT) in head and neck squamous cell carcinoma (HNSCC) is within 6 weeks of surgical treatment. Delays in guideline-adherent PORT initiation are common, associated with mortality, and a measure of quality care, but patient-specific tools to estimate the risk of these delays are lacking.

Objective: To develop and validate 2 nomograms (that use presurgical and postsurgical data) for predicting delayed PORT initiation.

Design, Setting, And Participants: This cohort study obtained patient data from January 1, 2004, to December 31, 2015, from the National Cancer Database. Adults aged 18 years or older with a newly diagnosed HNSCC who underwent surgical treatment and PORT at a Commission on Cancer-accredited facility were included. Data analysis was conducted from June 2, 2019, to January 29, 2020.

Exposures: Surgical treatment and PORT.

Main Outcomes And Measures: The primary outcome measure was PORT initiation more than 6 weeks after the surgical intervention. Multivariable logistic regression models were created in a random selection of 80% of the sample (derivation cohort) and were internally validated with bootstrapping, assessed for discrimination by calibration plots and the concordance (C) index, and externally validated in the remaining 20% of the sample (validation cohort).

Results: The study included 60 766 adults with HNSCC who were grouped into derivation and validation cohorts. The derivation cohort comprised 48 625 patients (mean [SD] age, 59.59 [11.3] years; 36 825 men [75.7%]) selected randomly from the full sample, whereas 12 151 patients (mean [SD] age, 59.63 [11.2] years; 9266 men [76.3%]) composed the validation cohort. The rate of PORT delay was 55.8% (n=27140) in the derivation cohort and 56.7% (n=6900) in the validation cohort. Both nomograms created to predict the risk of PORT initiation delay used variables, including race/ethnicity, insurance type, tumor site, and facility type. The nomogram based on presurgical variables included clinical stage and severity of comorbidity, whereas the nomogram with postsurgical variables included US region, length of stay, and care fragmentation between surgical and radiotherapy facilities. For the presurgical nomogram, the concordance indices were 0.670 (95% CI, 0.664-0.676) in the derivation cohort and 0.674 (95% CI, 0.662-0.685) in the validation cohort. For the nomogram with postsurgical variables, the concordance indices were 0.691 (95% CI, 0.686-0.696) in the derivation cohort and 0.694 (95% CI, 0.685-0.704) in the validation cohort.

Conclusions And Relevance: This study found that a nomogram developed with presurgical data to generate personalized estimates of PORT initiation delay may improve pretreatment counseling and the delivery of interventions to patients at high risk for such a delay. A nomogram including postsurgical data can drive institutional quality improvement initiatives and enhance risk-adjusted comparisons of delay rates across facilities.
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http://dx.doi.org/10.1001/jamaoto.2020.0222DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7118672PMC
May 2020

An Implementation Trial to Improve Tobacco Treatment for Cancer Patients: Patient Preferences, Treatment Acceptability and Effectiveness.

Int J Environ Res Public Health 2020 03 28;17(7). Epub 2020 Mar 28.

Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL 32610, USA.

Continued smoking after a cancer diagnosis increases mortality, risk of recurrence, and negatively impacts treatment effectiveness. However, utilization of tobacco use cessation treatment among cancer patients remains low. We conducted a clinical trial assessing patient preferences, treatment acceptability, and preliminary effectiveness (7-day point prevalence at 12 weeks) of three tobacco treatment options among cancer patients at an academic health center. Implementation strategies included electronic referral and offering the choice of three treatment options: referral to external services, including the quitline (PhoneQuit) and in-person group counseling (GroupQuit), or an internal service consisting of 6-week cognitive behavioral therapy delivered via smartphone video conferencing by a tobacco treatment specialist (SmartQuit). Of 545 eligible patients, 90 (16.5%) agreed to enroll. Of the enrolled patients, 39 (43.3%) chose PhoneQuit, 37 (41.1%) SmartQuit, and 14 (15.6%) GroupQuit. Of patients reached for 12-week follow-up (n = 35), 19 (54.3%) reported receiving tobacco treatment. Of all patients referred, 3 (7.7%) PhoneQuit, 2 (5.4%) SmartQuit, and 2 (14.3%) GroupQuit patients reported 7-day point prevalence abstinence from smoking at 12 weeks. Participants rated the SmartQuit intervention highly in terms of treatment acceptability. Results indicate that more intensive interventions may be needed for this population, and opportunities remain for improving reach and utilization.
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http://dx.doi.org/10.3390/ijerph17072280DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7177357PMC
March 2020

Smoking Cessation After a Cancer Diagnosis Is Associated With Improved Survival.

J Thorac Oncol 2020 05 18;15(5):705-708. Epub 2020 Mar 18.

Department of Psychiatry and Behavioral Sciences, MUSC, Charleston, South Carolina.

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http://dx.doi.org/10.1016/j.jtho.2020.02.002DOI Listing
May 2020

Using a Quitline to Deliver Opt-Out Smoking Cessation for Cancer Patients.

JCO Oncol Pract 2020 06 29;16(6):e549-e556. Epub 2020 Jan 29.

Department of Radiation Oncology, Department of Cell and Molecular Pharmacology, Medical University of South Carolina, Charleston, SC.

Purpose: Although smoking by patients with cancer and survivors causes adverse outcomes, many patients with cancer do not receive access to evidence-based tobacco use treatment. The purpose of this article is to report on delivery of tobacco use treatment to patients with cancer using a state-supported Quitline.

Methods: Statewide agencies in Michigan partnered with the Michigan Oncology Quality Consortium to develop and implement a clinical quality improvement initiative with the goal of addressing tobacco use by patients with cancer across Michigan oncology practices. The collaborative designed an opt-out approach for identifying tobacco users and referring them to the Michigan Tobacco Quitline (hereafter known as Quitline) within participating practices. As the initiative progressed, patients with cancer who were not referred through the initiative also became eligible for enrollment in the Quitline program.

Results: A total of 4,347 patients with cancer enrolled in the Quitline between 2012 and 2017, and annual referrals from oncology practices increased from 364 (5% of Quitline participants) to 876 (17% of Quitline participants). The 2013-2016 Michigan Behavioral Risk Factor Surveillance System also demonstrated an increase from 60% to 80% of cancer survivors receiving smoking cessation resources. Of 3,892 patients with cancer who had Quitline follow-up data through 2017, 79% completed one or more counseling calls. The 6-month self-reported quit rate for patients with cancer assessed between 2013 and 2016 was 26%.

Conclusion: Using statewide resources to increase access to evidence-based smoking cessation assistance to patients with cancer is achievable. In an increasingly cost-conscious health care environment, collaborative initiatives that use or enhance existing resources should be considered and refined to deliver effective evidence-based care.
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http://dx.doi.org/10.1200/JOP.19.00296DOI Listing
June 2020

Modeling rectal cancer to advance neoadjuvant precision therapy.

Int J Cancer 2020 09 3;147(5):1405-1418. Epub 2020 Feb 3.

Department of Surgery, Medical University of South Carolina, Charleston, SC.

Progress in rectal cancer therapy has been hindered by the lack of effective disease-specific preclinical models that account for the unique molecular profile and biology of rectal cancer. Thus, we developed complementary patient-derived xenograft (PDX) and subsequent in vitro tumor organoid (PDTO) platforms established from preneoadjuvant therapy rectal cancer specimens to advance personalized care for rectal cancer patients. Multiple endoscopic samples were obtained from 26 Stages 2 and 3 rectal cancer patients prior to receiving 5FU/RT and implanted subcutaneously into NSG mice to generate 15 subcutaneous PDXs. Second passaged xenografts demonstrated 100% correlation with the corresponding human cancer histology with maintained mutational profiles. Individual rectal cancer PDXs reproduced the 5FU/RT response observed in the corresponding human cancers. Similarly, rectal cancer PDTOs reproduced significant heterogeneity in cellular morphology and architecture. PDTO in vitro 5FU/RT treatment response replicated the clinical 5FU/RT neoadjuvant therapy pathologic response observed in the corresponding patient tumors (p < 0.05). The addition of cetuximab to the 5FU/RT regiment was significantly more sensitive in the rectal cancer PDX and PDTOs with wild-type KRAS compared to mutated KRAS (p < 0.05). Considering the close relationship between the patient's cancer and the corresponding PDX/PDTO, rectal cancer patient-derived research platforms represent powerful translational research resources as population-based tools for biomarker discovery and experimental therapy testing. In addition, our findings suggest that cetuximab may enhance RT effectiveness by improved patient selection based on mutational profile in addition to KRAS or by developing a protocol using PDTOs to identify sensitive patients.
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http://dx.doi.org/10.1002/ijc.32876DOI Listing
September 2020

Smoking Cessation and Low-Dose Computed Tomography Screening: A Necessary Pair.

J Thorac Oncol 2019 09;14(9):1495-1497

Department of Family Medicine, University of North Carolina, Chapel Hill, North Carolina.

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http://dx.doi.org/10.1016/j.jtho.2019.05.038DOI Listing
September 2019

Mitigating the adverse health effects and costs associated with smoking after a cancer diagnosis.

Authors:
Graham W Warren

Transl Lung Cancer Res 2019 May;8(Suppl 1):S59-S66

Department of Radiation Oncology, Department of Cell and Molecular Pharmacology, Medical University of South Carolina, Charleston, SC, USA.

Smoking after a cancer diagnosis causes adverse outcomes and is associated with substantial additional treatment cost. Mitigation of the adverse effects of smoking require active commitment from health systems, providers, and patients. Three areas of mitigation are discussed: (I) smoking cessation after a cancer diagnosis to improve cancer treatment outcomes; (II) identifying optimal cancer treatment strategies for patients who smoke at the time of diagnosis; and (III) how health systems can prioritize the effect modification caused by smoking. As innovation continues for healthcare delivery, priority should be placed on interventions that reduce the effect modification and associated costs caused by continued smoking after a cancer diagnosis.
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http://dx.doi.org/10.21037/tlcr.2019.04.07DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6546628PMC
May 2019

Attributable Failure of First-line Cancer Treatment and Incremental Costs Associated With Smoking by Patients With Cancer.

JAMA Netw Open 2019 04 5;2(4):e191703. Epub 2019 Apr 5.

Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston.

Importance: Previous studies have shown that continued smoking among patients with cancer can increase overall and cancer-specific mortality, risk for second primary cancer, and risk for toxic effects of cancer treatment. To our knowledge, there have been no efforts to estimate additional costs for cancer treatment attributed to smoking.

Objective: To model attributable incremental costs of subsequent cancer treatment associated with continued smoking by patients with cancer.

Design, Setting, And Participants: For this economic evaluation, a model was developed in 2018 using data from a 2014 US Surgeon General's report that considered expected failure rates of first-line cancer treatment in nonsmoking patients, smoking prevalence, odds ratio of first-line cancer treatment failure attributed to smoking compared with nonsmoking, and cost of cancer treatment after failure of first-line cancer treatment.

Main Outcomes And Measures: Attributable failures of first-line cancer treatment and incremental cost for subsequent treatment associated with continued smoking among patients with cancer.

Results: Attributable treatment failures were higher under conditions in which high first-line cure rates were expected in nonsmoking patients compared with conditions in which low cure rates were expected. Peak attributable failures occurred under the conditions in which expected cure rates among nonsmoking patients ranged from 50% to 65%. Under the conditions of a 30% expected treatment failure rate among nonsmoking patients, 20% smoking prevalence, 60% increased risk of failure of first-line cancer treatment, and $100 000 mean added cost of treating a first-line cancer treatment failure, the additional incremental cost per 1000 total patients was estimated to be $2.1 million, reflecting an additional cost of $10 678 per smoking patient. Extrapolation of cost to 1.6 million patients with cancer diagnosed annually reflects a potential $3.4 billion in incremental cost.

Conclusions And Relevance: The findings suggest that continued smoking among patients with cancer and the increase in attributable first-line cancer treatment failure is associated with significant incremental costs for subsequent cancer treatments. Additional work appears to be needed to identify optimal methods to mitigate these incremental costs.
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http://dx.doi.org/10.1001/jamanetworkopen.2019.1703DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6450325PMC
April 2019

Indeed, Nuance Matters.

J Thorac Oncol 2019 01;14(1):e16-e17

Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.

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http://dx.doi.org/10.1016/j.jtho.2018.11.004DOI Listing
January 2019

Association of Treatment Delays With Survival for Patients With Head and Neck Cancer: A Systematic Review.

JAMA Otolaryngol Head Neck Surg 2019 02;145(2):166-177

Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston.

Importance: Delays in the delivery of care for head and neck cancer (HNC) are a key driver of poor oncologic outcomes and thus represent an important therapeutic target.

Objective: To synthesize information about the association between delays in the delivery of care for HNC and oncologic outcomes.

Evidence Review: A systematic review of the English-language literature in PubMed/MEDLINE and Scopus published between January 1, 2007, and February 28, 2018, was performed to identify articles addressing the association between treatment delays and oncologic outcomes for patients with HNC. Articles that were included (1) addressed cancer of the oral cavity, oropharynx, hypopharynx, or larynx; (2) discussed patients treated in 2004 or later; (3) analyzed time of diagnosis to treatment initiation (DTI), time from surgery to the initiation of postoperative radiotherapy, and/or treatment package time (TPT; the time from surgery through the completion of postoperative radiotherapy); (4) included a clear definition of treatment delay; and (5) analyzed the association between the treatment time interval and an oncologic outcome measure. Quality assessment was performed using the Institute of Health Economics Quality Appraisal Checklist for Case Series Studies.

Findings: A total of 18 studies met inclusion criteria and formed the basis of the systematic review. Nine studies used the National Cancer Database and 6 studies were single-institution retrospective reviews. Of the 13 studies assessing DTI, 9 found an association between longer DTI and poorer overall survival; proposed DTI delay thresholds ranged from more than 20 days to 120 days or more. Four of the 5 studies assessing time from surgery to the initiation of postoperative radiotherapy (and all 4 studies assessing guideline-adherent time to postoperative radiotherapy) found an association between a timely progression from surgery to the initiation of postoperative radiotherapy and improved overall or recurrence-free survival. Of the 5 studies examining TPT, 4 found that prolonged TPT correlated with poorer overall survival; proposed thresholds for prolonged TPT ranged from 77 days or more to more than 100 days.

Conclusions And Relevance: Timely care regarding initiation of treatment, postoperative radiotherapy, and TPT is associated with survival for patients with HNC, although significant heterogeneity exists for defining delayed DTI and TPT. Further research is required to standardize optimal time goals, identify barriers to timely care for each interval, and design interventions to minimize delays.
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http://dx.doi.org/10.1001/jamaoto.2018.2716DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6494704PMC
February 2019

Effect of an Evidence-based Inpatient Tobacco Dependence Treatment Service on 1-Year Postdischarge Health Care Costs.

Med Care 2018 10;56(10):883-889

Hollings Cancer Center.

Background: In 2014, the Medical University of South Carolina (MUSC) implemented a Tobacco Dependence Treatment Service (TDTS) consistent with the Joint Commission (JC) standards recommending that hospitals screen patients for smoking, provide cessation support, and follow-up contact for relapse prevention within 1 month of discharge. We previously demonstrated that patients exposed to the MUSC TDTS were approximately half as likely to be smoking one month after discharge and 23% less likely to have a 30-day hospital readmission. This paper examines whether exposure to the TDTS influenced downstream health care charges 12 months after patients were discharged from the hospital.

Methods: Data from MUSC's electronic health records, the TDTS, and statewide health care utilization datasets (eg, hospitalization, emergency department, and ambulatory surgery visits) were linked to assess how exposure to the MUSC TDTS impacted health care charges. Total health care charges were compared for patients with and without TDTS exposure. To reduce potential TDTS exposure selection bias, propensity score weighting was used to balance baseline characteristics between groups. The cost of delivering the MUSC TDTS intervention was calculated, along with cost per smoker.

Results: The overall adjusted mean health care charges for smokers exposed to the TDTS were $7299 lower than for those who did not receive TDTS services (P=0.047). The TDTS cost per smoker was modest by comparison at $34.21 per smoker eligible for the service.

Discussion: Results suggest that implementation of a TDTS consistent with JC standards for smoking cessation can be affordably implemented and yield substantial health care savings that would benefit patients, hospitals, and insurers.
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http://dx.doi.org/10.1097/MLR.0000000000000979DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6136961PMC
October 2018

Considering Systemic Barriers to Treating Tobacco Use in Clinical Settings in the United States.

Nicotine Tob Res 2019 10;21(11):1453-1461

Department of Radiation Oncology, Medical University of South Carolina, Charleston, SC.

The Comorbidity Workgroup of the Tobacco Treatment Research Network, within the Society for Research on Nicotine and Tobacco, previously highlighted the need to provide tobacco treatment to patients diagnosed with comorbid physical and mental health conditions. Yet, systemic barriers in the United States health care system prevent many patients who present for medical treatment from getting the evidence-based tobacco treatment that they need. The identified barriers include insufficient training in the epidemiologic impact of tobacco use, related disorders, and pharmacological and behavioral treatment approaches; misunderstanding among clinicians about the effectiveness of tobacco treatment; lack of therapeutic support from clinical staff; insufficient use of health information technology to improve tobacco use identification and treatment; and limited time and reimbursement for clinicians to provide treatment. We highlight three vignettes demonstrating the complexities of practical barriers at the health care system level. We consider each of the barriers in turn and discuss evidence-based strategies that could be implemented in the clinical care of patients with comorbid conditions. In addition, in the absence of compelling data to guide implementation approaches, we offer suggestions for potential strategies and avenues for future research. Implications: Three vignettes highlighted in this article illustrate some systemic barriers to providing tobacco treatment for patients being treated for comorbid conditions. We explore the barriers to tobacco treatment and offer suggestions for changes in training, health care systems, clinical workflow, and payment systems that could enhance the reach and the quality of tobacco treatment within the US health care system.
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http://dx.doi.org/10.1093/ntr/nty123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6941704PMC
October 2019

Practice Patterns and Perceptions of Chest Health Care Providers on Electronic Cigarette Use: An In-Depth Discussion and Report of Survey Results.

J Smok Cessat 2018 Jun 9;13(2):72-77. Epub 2017 Apr 9.

Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC.

Introduction: The emergence of electronic cigarettes (ECs) has become a growing phenomenon that has sharply split opinion among the public health community, physicians, and lawmakers.

Aims: We sought to determine chest physician perceptions regarding ECs.

Methods: We conducted a web-based survey of 18,000 American College of Chest Physician (CHEST) members to determine healthcare provider experiences with EC users and to characterize provider perceptions regarding ECs.

Results/findings: There were 994 respondents. 88% reported that patients had asked their opinion of ECs, and 31% reported EC use among at least 10% of their patients. More disagreed than agreed (41% vs. 21%) that patients could improve their health by switching from tobacco smoking to daily EC use. Respondents were split on whether ECs promote tobacco cessation (32% agree vs. 33% disagree).

Conclusions: Current perceptions of ECs are variable among providers. More than 1/3 of respondents felt that EC's could be used for smoking cessation for smokers who failed prior quit attempts with approved therapies. However, many respondents were not convinced that ECs will reduce harms from tobacco use. There is an urgent need to generate additional high quality scientific data regarding ECs to inform chest physicians, health professionals and the general public.
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http://dx.doi.org/10.1017/jsc.2017.6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5985665PMC
June 2018

"Teachable Moment" Interventions in Lung Cancer: Why Action Matters.

J Thorac Oncol 2018 05;13(5):603-605

Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.

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http://dx.doi.org/10.1016/j.jtho.2018.02.020DOI Listing
May 2018
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