Cost Effectiveness of Treatment Sequences in Advanced Renal Cell Carcinoma.

BACKGROUND: The treatment landscape for metastatic renal cell carcinoma (mRCC) has significantly evolved in recent years. Without direct comparator trials, factors such as cost effectiveness (CE) are important to guide decision-making. OBJECTIVE: To assess the CE of guideline-recommended approved first- and second-line treatment regimens. DESIGN, SETTING, AND PARTICIPANTS: A comprehensive Markov model was developed to analyze the CE of the five current National Comprehensive Cancer Network-recommended first-line therapies with appropriate second-line therapy for patient cohorts with International Metastatic RCC Database Consortium favorable and intermediate/poor risk. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Life years, quality-adjusted life years (QALYs), and total accumulated costs were estimated using a willingness-to-pay threshold of $150 000 per QALY. One-way and probabilistic sensitivity analyses were performed. RESULTS AND LIMITATIONS: In patients with favorable risk, pembrolizumab + lenvatinib followed by cabozantinib added $32 935 in costs and yielded 0.28 QALYs, resulting in an incremental CE ratio (ICER) of $117 625 per QALY in comparison to pembrolizumab + axitinib followed by cabozantinib. In patients with intermediate/poor risk, nivolumab + ipilimumab followed by cabozantinib added $2252 in costs and yielded 0.60 QALYs compared to cabozantinib followed by nivolumab, yielding an ICER of $4184. Limitations include differences in median follow-up duration between treatments. CONCLUSIONS: Pembrolizumab + lenvatinib followed by cabozantinib, and pembrolizumab + axitinib followed by cabozantinib were cost-effective treatment sequences for patients with favorable-risk mRCC. Nivolumab +ipilimumab followed by cabozantinib was the most cost-effective treatment sequence for patients with intermediate-/poor-risk mRCC, dominating all preferred treatments. PATIENT SUMMARY: Because new treatments for kidney cancer have not been compared head to head, comparison of their cost and efficacy can help in making decisions about the best treatments to use first. Our model showed that patients with a favorable risk profile are most likely to benefit from pembrolizumab and lenvatinib or axitinib followed by cabozantinib, while patients with an intermediate or poor risk profile will probably benefit most from nivolumab and ipilimumab followed by cabozantinib.

Inflammation as a Therapeutic Target in Cancer Cachexia.

Cachexia is a common complication of cancer and is associated with poor quality of life and a decrease in survival. Many patients with cancer cachexia suffer from inflammation associated with elevated cytokines, such as interleukin-1beta (IL-1ß), interleukin-6 (IL-6), and tumor necrosis factor (TNF). Single-agent trials to treat cancer cachexia have not led to substantial benefit as the type of cytokine which is elevated has rarely been specified and targeted. Cachexia may also be multifactorial, involving inflammation, anorexia, catabolism, depression, and pain, and targeting the multiple causes will likely be necessary to achieve improvement in weight and appetite. A PUBMED search revealed over 3000 articles on cancer cachexia in the past ten years. We attempted to review any studies related to inflammation and cancer cachexia identified by Google Scholar and PUBMED and further search for articles listed in their references. The National Comprehensive Cancer Network (NCCN) guidelines do not provide any suggestion for managing cancer cachexia except a dietary consult. A more targeted approach to developing therapies for cancer cachexia might lead to more personalized and effective therapy.

Training cancer caregiver navigators: experiences from implementing the eSNAP and caregiver navigator intervention.

Patient navigation is increasingly common in cancer care. While navigation programs often involve informal family caregivers, few navigation interventions specifically target the family caregiver. We developed the eSNAP and Caregiver Navigator Intervention to help cancer family caregivers identify and capitalize on informal and formal social support resources. While the skill set for patient navigators may be adequate for supporting caregivers, other skills and areas of knowledge expertise are needed. In addition, sparse documentation of navigator training best practices creates further challenges for dissemination and implementation. Our goal is to describe the education and training of cancer caregiver navigators within key competencies used to prepare and support navigators to deliver our manualized intervention. Nationally recognized navigation competencies, related to developing a sensitivity to ethical, cultural, and professional issues, knowledge development, skills development, and practice-based learning, were identified and adapted. Performance goals were identified within each competency. Training activities were selected to support competency development. Based on adult learning theories, we emphasize multiple learning strategies, including experiential learning and critical reflection. Two caregiver navigators engaged in initial training between December, 2019 and February, 2020. Initial training was supervised by study leadership, who coordinated with experts and stakeholders. Navigators completed initial training. We describe lessons learned. To ensure that navigators are well-equipped to provide effective services, evidence-based training programs that include navigation and protocol-specific competencies are needed. Given the lack of detailed training programs in the literature, we created a flexible, multimodal learning approach that other teams may adopt.

Prenatal Diagnosis of Craniosynostosis Using Ultrasound.

BACKGROUND: Craniosynostosis is typically diagnosed postnatally. Prenatal diagnosis would allow for improved parental counseling and facilitate timely intervention. Our purpose was to determine whether prenatal ultrasound can be used to diagnose nonsyndromic craniosynostosis. METHODS: The authors reviewed 22 prenatal ultrasounds of infants known to have nonsyndromic craniosynostosis and 22 age-matched controls. Cross-sectional images at the plane used to measure biparietal diameter were selected and cranial shape of each participant was parameterized and used to discriminate affected patients from controls. The results from quantitative shape analysis were compared with results from a blinded visual inspection alone. RESULTS: Among the 22 patients, the most common diagnosis was sagittal synostosis ( n = 11), followed by metopic synostosis ( n = 6). The average gestational age at time of ultrasound of controls and synostotic patients was 26 weeks and 6.8 days at the junction of the second and third trimesters. The controls and synostotic cases segregated into statistically different populations by their shape profiles ( p < 0.001). An automatic shape classifier using leave-one-out cross-validation correctly classified the 44 images as normal versus synostotic 85 percent of the time (sensitivity, 82 percent; specificity, 87 percent). Cephalic index was a poor indicator of sagittal synostosis (45 percent sensitivity). Visual inspection alone demonstrated only a fair level of accuracy (40 to 50 percent agreement) in identifying cases of synostosis (kappa, 0.09 to 0.23). CONCLUSIONS: Craniosynostosis can be identified on prenatal ultrasound with good sensitivity using formal shape analysis. Cephalic index and visual inspection alone performed poorly. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, II.

Pharmacological ascorbate improves the response to platinum-based chemotherapy in advanced stage non-small cell lung cancer.

PURPOSE: Platinum-based chemotherapy with or without immunotherapy is the mainstay of treatment for advanced stage non-small cell lung cancer (NSCLC) lacking a molecular driver alteration. Pre-clinical studies have reported that pharmacological ascorbate (P-AscH-) enhances NSCLC response to platinum-based therapy. We conducted a phase II clinical trial combining P-AscH- with carboplatin-paclitaxel chemotherapy. EXPERIMENTAL DESIGN: Chemotherapy naïve advanced stage NSCLC patients received 75 g ascorbate twice per week intravenously with carboplatin and paclitaxel every three weeks for four cycles. The primary endpoint was to improve tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 compared to the historical control of 20%. The trial was conducted as an optimal Simon's two-stage design. Blood samples were collected for exploratory analyses. RESULTS: The study enrolled 38 patients and met its primary endpoint with an objective response rate of 34.2% (p = 0.03). All were confirmed partial responses (cPR). The disease control rate was 84.2% (stable disease + cPR). Median progression-free and overall survival were 5.7 months and 12.8 months, respectively. Treatment-related adverse events (TRAE) included one grade 5 (neutropenic fever) and five grade 4 events (cytopenias). Cytokine and chemokine data suggest that the combination elicits an immune response. Immunophenotyping of peripheral blood mononuclear cells demonstrated an increase in effector CD8 T-cells in patients with a progression-free survival (PFS) ≥ 6 months. CONCLUSIONS: The addition of P-AscH- to platinum-based chemotherapy improved tumor response in advanced stage NSCLC. P-AscH- appears to alter the host immune response and needs further investigation as a potential adjuvant to immunotherapy.

Hispanic/Latinx Ethnic Subgroup Differences in Sociodemographic, Sociocultural, and Smoking Characteristics in a Cessation Trial: An Exploratory Study.

INTRODUCTION: Hispanic/Latinx smokers in the United States are often treated as a homogeneous group. However, population-based studies suggest that cigarette use differs among Hispanic/Latinx subgroups by sociodemographic or sociocultural characteristics. This secondary analysis aimed to advance the limited literature by examining differences in smoking-related variables. AIMS AND METHODS: We used baseline data from a randomized controlled trial testing a self-help Spanish-language smoking cessation intervention. Puerto Rican (PR), Mexican, and Cuban, the three largest Hispanic/Latinx subgroups in the sample (N = 1028), were first compared on sociodemographic and sociocultural variables (acculturation and familism). Primary analyses assessed subgroup differences in cigarette use variables (eg, cigarettes per day [CPD], nicotine dependence [Fagerström Test for Nicotine Dependence], and daily smoking) and smoking-related cognitive constructs (motivation to quit, smoking outcome expectancies, and abstinence self-efficacy) controlling for sociodemographic and sociocultural variables. Additional analyses explored differences between men and women within subgroups. RESULTS: Mexicans exhibited the lowest levels of daily smoking (90% vs. 95% Cubans and 96% PR; p = .001), CPD (M = 13.5, SD = 9.5 vs. M = 20.1, SD = 9.9 Cubans and M = 16.7, SD = 10.1 PR; p = .016), and nicotine dependence (M = 4.2, SD = 2.3 vs. M = 6.0, SD = 2.1 Cubans and M = 5.7, SD = 2.2 PR; p < .001), with no differences between PRs and Cubans. Within-subgroup comparisons between men and women showed the most differences among PRs (eg, men were more nicotine dependent [M = 6.0, SD = 1.9] than women [M = 5.4, SD = 2.3; p = .041]) and Cubans (eg, men smoked more CPD [M = 22.2, SD = 12.2] than women [M = 19.3, SD = 12.0; p = .042]), and the fewest among Mexicans. CONCLUSIONS: Findings support heterogeneity within Hispanic/Latinx smokers and highlight the potential utility of examining sociodemographic, sociocultural, and smoking characteristics important for developing salient cessation interventions. IMPLICATIONS: Findings demonstrate that treatment-seeking Hispanic/Latinx smokers in the United States differ in sociodemographic, sociocultural, and smoking-related variables (cigarette use and smoking-related cognitive constructs) by subgroup (ie, PR, Mexican, and Cuban) and within subgroups by sex. These differences suggest that heterogeneity among subgroups should be considered when developing cessation interventions for Hispanics/Latinxs. Future research should examine how differences in sociodemographic and smoking-related variables impact intervention outcomes and explore the role of sociocultural factors (eg, acculturation and familism) as determinants of cessation.

Addressing a critical need for caregiver support in neuro-oncology: development of a caregiver navigation intervention using eSNAP social resource visualization.

Informal caregivers are key to oncology care, but often have unmet needs, leading to poor psychological and physical health outcomes. Comprehensive, proactive caregiver support programs are needed. We describe the development of a support intervention for caregivers of persons with brain tumors. The intervention uses a caregiver navigator to help participants identify and capitalize on existing social support resources captured using a web-based tool (eSNAP) and connects participants to existing formal services. We describe the iterative development process of the manualized intervention with particular focus on the caregiver navigator sessions. The process included review of the literature and published patient navigation programs, expert and stakeholder review, and study team member review. Quantitative and qualitative data were captured from the first 15 participants randomized to receive the intervention, enrolled from February 2020 to December 2020. Four participants dropped from the study, 9 completed at least 7 modules, and 8 participants completed all 8. Quantitative and qualitative data were collected primarily from those who completed the intervention; data suggest caregivers were satisfied with the intervention and found it helpful. Our intervention is one of the first theory-based caregiver support interventions to include caregiver navigation in neuro-oncology. We use best-practice guidelines for design, including extensive stakeholder feedback. COVID-19 may have impacted recruitment and participation, but some preliminary data suggest that those able to engage with the intervention find it helpful. Data collection is ongoing in a larger trial. If effective, caregiver navigation could be a model for future interventions to ensure caregiver support.

Parenchyma-Sparing Central Hepatectomy Versus Extended Resections for Liver Tumors: a Value-Based Comparative Analysis.

BACKGROUND: Parenchyma-sparing (PS) liver resection is recommended for liver tumors. The value of PS-approaches as compared to more extended resections is unknown. We sought to examine value-based differences (quality/cost) of central hepatectomy (CH) versus more extended resections. METHODS: A retrospective cohort study including consecutive patients having CH or right/extended hepatectomies (R/EH) at a high-volume cancer center was performed (2015-2019). The primary outcome was the value ratio, calculated as quality/cost. Quality was defined as the proportion of patients achieving a textbook outcome. Perioperative actual direct costs ($USD) for each patient were abstracted from institutional financial records spanning throughout the perioperative period. Value ratios were calculated and compared for each approach; sensitivity analysis was performed by modelling TO and cost thresholds. RESULTS: Among 651 hepatobiliary operations (426 liver resections), 90 patients met inclusion criteria: 19 CH and 71 R/EH. TO occurred in 68% and 69% of CH and R/EH, respectively (P = 0.96). Mean direct costs were $21,826 for CH and $28,599 for R/EH (P = 0.008). CH provided a greater value (value ratio CH = 0.33 vs. R/EH = 0.26; P = 0.004) with a shift favoring R/EH only when the TO threshold for CH was below 51% (CH = 0.23 vs. R/EH = 0.24) or that of R/EH was over 90% (CH = 0.31 vs. R/EH = 0.32). CONCLUSIONS: These findings support a PS approach for central liver tumors (central hepatectomy) as it offers higher value than more extended resections. In the context of high-volume centers with outcomes within established national benchmarks, patients with central tumors should be considered for CH over more extended non-PS approaches.

Tailored Messages About Research Participation: Using an Interactive Information Aid to Improve Study Recruitment.

After a diagnosis of cancer (or other serious disease), patients may be asked to consider joining a clinical trial. Because most people are unfamiliar with the scientific concepts that are necessary to the provision of meaningful informed consent, patient education is necessary. Increasing knowledge alone is not sufficient; understanding how clinical trial participation aligns with personal circumstances and knowledge is central to the decision-making process. In this study, 302 cancer patients and survivors evaluated an interactive information aid (IA) designed to inform their decision to join a research study or clinical trial by providing tailored information to patients' responses to questions pertaining to seven key barriers or facilitators of clinical trial participation. The development of the IA was done with input from the authors' Clinical Translational Science Institute; linked components of the IA were vetted by members and leaders of the institution's NCI-designated comprehensive cancer center. Results of the study indicated that the information aid was successful in significantly reducing fears and increasing knowledge, attitudes, perceived behavioral control, and behavioral intentions about research participation relative to a control condition. Thus, an interactive information aid that provides information that is responsive to patients' values, knowledge, and personal circumstances can help patients to be better prepared to consider a decision about research participation.

Self-help smoking cessation intervention for Spanish-speaking Hispanics/Latinxs in the United States: A randomized controlled trial.

BACKGROUND: Hispanic/Latinx smokers living in the United States face unique challenges in quitting smoking. This study evaluated the efficacy of a culturally relevant, Spanish-language, extended self-help smoking cessation intervention among Hispanic smokers. METHODS: A 2-arm parallel randomized controlled trial was conducted with Hispanic/Latinx smokers living in the United States who preferred health information in Spanish and smoked 5 or more cigarettes per week. Participants were randomly allocated to receive Libre del Cigarrillo (LDC), which consisted of 11 booklets and 9 pamphlets mailed monthly over 18 months, or the usual care (UC), which was a single Spanish-language self-help booklet from the National Cancer Institute. The primary outcome was self-reported 7-day point prevalence smoking abstinence assessed 6, 12, 18, and 24 months after the baseline. Eight prespecified moderators of the intervention were evaluated. Cost-effectiveness was also evaluated. All statistical tests were 2-sided. RESULTS: Data from all participants randomized to LDC (n = 714) or UC (n = 703) were used for analyses after multiple imputation to manage missing data. Generalized estimating equation analyses indicated that LDC abstinence rates were higher (P < .001) across all assessments. Logistic regression analyses revealed that at 24 months, the abstinence rate was greater for LDC (33.1%) than UC (24.3%; odds ratio, 1.54; 95% confidence interval, 1.18-2.02; P = .002). Men exhibited a strong intervention effect at all assessments (P values < .001), whereas the intervention effect for women was observed only at 6 and 12 months (P values < .018). In comparison with UC, the incremental cost per quitter in the LDC arm was $648.43 at 18 months and $683.93 at 24 months. CONCLUSIONS: A culturally relevant, Spanish-language intervention was efficacious and cost-effective for smoking cessation. LAY SUMMARY: Research is needed to develop interventions for ethnic minority smokers. The aim of the current study was to test a Spanish-language adaptation of a validated and easily implemented self-help smoking cessation intervention in a nationwide randomized controlled trial. The findings demonstrated that the intervention produced greater smoking abstinence in comparison with a standard self-help booklet. Participants also were more satisfied with the intervention, and it was cost-effective. Efforts aimed at promoting tobacco abstinence in this underserved population could have significant public health implications, including potential reductions in cancer health disparities associated with tobacco smoking.

Feasibility, acceptability, and effectiveness of a decision aid versus an informational website to promote clinical trial decision-making among cancer patients: A pilot randomized controlled trial.

OBJECTIVE: To assess intervention feasibility and acceptability, and compare the effectiveness of the CHOICES Decision Aid (DA) versus the National Cancer Institute (NCI) Cancer Clinical Trials (CCT) website to improve knowledge about CCTs and preparedness to make an informed decision. METHODS: Oncology patients (n = 101) with a scheduled clinic visit were enrolled and randomized. Decision-making variables were collected at two timepoints. Post-intervention scores were examined via paired t-tests and multivariate regression analyses. Predictors of the magnitudes of the change in scores were examined in multivariable regression analyses. RESULTS: The interventions were feasible to implement and acceptable to participants. Both interventions increased objective and subjective knowledge, improved clarity of opinions, and reduced decisional conflict (p-values < 0.01). Improvements in the belief that one could find out about CCTs were observed in the CHOICES DA arm (p < 0.001). Multivariable analyses controlling for educational attainment showed no significant differences in the magnitude of change in outcome variables between intervention arms, but did find that improvements in some variables in the NCI arm - but not CHOICES DA arm - were associated with previous educational attainment. CONCLUSIONS: Interventions were feasible to implement and acceptable. Improvements in knowledge and decision-making outcomes were observed in both arms, supporting the view that interventions to improve CCT decision making are effective and feasible. Our results suggest that the CHOICES DA may be more effective than an informational website in improving decision-making outcomes regardless of participants' educational attainment. PRACTICE IMPLICATIONS: CCT resources should support informed decision-making among all cancer survivors, regardless of educational attainment.

Immune-related adverse events in cancer patients being treated with immune checkpoint inhibitors.

INTRODUCTION: With the increased use of immune checkpoint inhibitors (ICI), it is essential to improve our understanding of immune-related adverse events (irAE). To date, most studies describing irAE have been performed in clinical trial populations, which may not be an accurate description of irAE in real-world populations. Also, identification of patients at increased risk of irAE is needed as early recognition may improve irAE outcomes. METHODS: We performed a retrospective analysis of patients who received an ICI between January 2014 and October 2018 at a single institution (Tufts Medical Center). Each patient was followed for up to 12 months for the outcome of a physician-reported irAE. Kaplan-Meier curves were created for the time to development and resolution of initial irAE. A Cox proportional hazards model was created to evaluate whether the following variables were independent predictors of an initial irAE: age ≥65 years, female sex, non-Caucasian race, radiation in previous 6 months, current smoking status, melanoma, and combination ICI (ipilimumab and nivolumab). RESULTS: Of 131 patients followed, 57 patients (43.5%) developed at least one irAE at a median of 250 days (95% confidence interval (CI) 132 days-not estimable). The most common irAE included dermatitis, thyroid dysfunction, and pneumonitis. Nearly two-thirds of patients with an irAE had ICI therapy withdrawn, and nearly 60% had immunosuppression initiated. In multivariable analysis, we found a significant association between irAE development and age ≥65 years hazard ratio (HR) 1.80, 95% CI (1.03-3.14) and current smoking status (HR 2.26, 95% CI 1.06-4.82). DISCUSSION: We detected a high rate of irAE and that irAE and subsequent management can be clinically burdensome in this patient population. While further studies are needed to validate these findings, this study provides insights into the magnitude, time course, management of, and possible predictors of irAE in a real-world setting.

Targeted smoking cessation for dual users of combustible and electronic cigarettes: a randomised controlled trial.

BACKGROUND: Although many smokers use electronic cigarettes (e-cigarettes) to quit smoking, most continue to smoke while vaping. This dual use might delay cessation and increase toxicant exposure. We aimed to test the efficacy of a self-help intervention designed to help dual users to quit smoking. METHODS: In this three-arm randomised controlled trial we recruited individuals in the USA using Facebook and multimedia advertisements. Included participants were 18 years or older, smoked at least weekly in the preceding year, and vaped at least weekly in the preceding month. We used computer generated randomisation with balanced-permuted blocks (block size 10, with 2-4-4 ratio) to allocate participants to assessment only (ASSESS group), generic smoking cessation self-help booklets (GENERIC group), or booklets targeting dual users (eTARGET group). Individuals in the generic or targeted intervention groups received monthly cessation materials for 18 months, with assessments every 3 months for 24 months. The main outcome was self-reported 7-day point-prevalence smoking abstinence at each assessment point. All randomly allocated participants were included in primary analyses using generalised estimating equations for each of 20 datasets created by multiple imputation. Analysis of the χ2s produced an F test. The trial is registered with ClinicalTrials.gov, NCT02416011, and is now closed. FINDINGS: Between July 12, 2016, and June 30, 2017, we randomly assigned 2896 dual users (575 to assessment, 1154 to generic intervention, and 1167 to targeted self-help). 7-day point-prevalence smoking abstinence increased from 14% at 3 months to 42% at 24 months (F7,541·7=67·1, p<0·0001) in the overall sample. Targeted self-help resulted in higher smoking abstinence than did assessment alone throughout the treatment period (F1,973·8=10·20, p=0·0014 [α=0·017]). The generic intervention group had abstinence rates between those of the assessment and targeted groups, but did not significantly differ from either when adjusted for multiple comparisons (GENERIC vs eTARGET F1,1102·5=1·79, p=0·18 [α=0·05]; GENERIC vs ASSESS F1,676·7=4·29, p=0·039 [α=0·025]). Differences between study groups attenuated after the interventions ended. INTERPRETATION: A targeted self-help intervention with high potential for dissemination could be efficacious in promoting smoking cessation among dual users of combustible cigarettes and e-cigarettes. FUNDING: National Institute on Drug Abuse, National Cancer Institute.

A randomized wait-list controlled trial of a social support intervention for caregivers of patients with primary malignant brain tumor.

BACKGROUND: Informal family caregivers constitute an important and increasingly demanding role in the cancer healthcare system. This is especially true for caregivers of patients with primary malignant brain tumors based on the rapid progression of disease, including physical and cognitive debilitation. Informal social network resources such as friends and family can provide social support to caregivers, which lowers caregiver burden and improves overall quality of life. However, barriers to obtaining needed social support exist for caregivers. To address this need, our team developed and is assessing a multi-component caregiver support intervention that uses a blend of technology and personal contact to improve caregiver social support. METHODS: We are currently conducting a prospective, longitudinal 2-group randomized controlled trial which compares caregivers who receive the intervention to a wait-list control group. Only caregivers directly receive the intervention, but the patient-caregiver dyads are enrolled so we can assess outcomes in both. The 8-week intervention consists of two components: (1) The electronic Social Network Assessment Program, a web-based tool to visualize existing social support resources and provide a tailored list of additional resources; and (2) Caregiver Navigation, including weekly phone sessions with a Caregiver Navigator to address caregiver social support needs. Outcomes are assessed by questionnaires completed by the caregiver (baseline, 4-week, 8-week) and the cancer patient (baseline, and 8-week). At 8 weeks, caregivers in the wait-list condition may opt into the intervention. Our primary outcome is caregiver well-being; we also explore patient well-being and caregiver and patient health care utilization. DISCUSSION: This protocol describes a study testing a novel social support intervention that pairs a web-based social network visualization tool and resource list (eSNAP) with personalized caregiver navigation. This intervention is responsive to a family-centered model of care and calls for clinical and research priorities focused on informal caregiving research. TRIAL REGISTRATION: clinicaltrials.gov , Registration number: NCT04268979 ; Date of registration: February 10, 2020, retrospectively registered.

Characteristics and Outcomes of Lung Cancer Screening Among Individuals With or Without Cancer History.

BACKGROUND: Lung cancer screening with low-dose computed tomography (LDCT) can reduce mortality from lung cancer. Individuals with previous malignancy are at an increased risk of lung cancer but are often underrepresented in clinical trials. This study compares the outcomes of LDCT screening among individuals with and without cancer history. MATERIALS AND METHODS: The study cohort included consecutive participants undergoing LDCT screening at a tertiary care cancer institution. Abnormal screening result was defined as having Lung-RADS 3 or 4 at baseline (T0). Participant information was prospectively collected and predicted risk of lung cancer was calculated per the PLCOm2012 model. RESULTS: A total of 454 participants underwent LDCT screening. Abnormal screening result occurred in 57 (13.2%) participants at T0, and lung cancer was diagnosed in 11 (2.4%) participants. Among 153 individuals with cancer history, abnormal result occurred in 9.8%, compared with 15.4% among those without cancer history (P = .11). Lung cancer was diagnosed in 1.3%, compared with 3.5% (P = .22). The predicted risk of lung cancer at 6 years was higher among individuals with cancer history than those without: 4.8% versus 2.2% (P < .001). In a multivariable analysis, cancer history significantly reduced the likelihood of abnormal screening (odds ratio, 0.49; 95% confidence interval, 0.26-0.94; P = .03). We observed a higher proportion of participants who had a previous CT scan available for comparison at T0 among individuals with cancer history than those without: 43.1% versus 9.1% (P < .001). CONCLUSIONS: In this single-institutional study, individuals with cancer history were significantly less likely to have abnormal screening results than those without cancer history.

What Motivates You to Share? The Effect of Interactive Tailored Information Aids on Information Sharing about Clinical Trials.

Cancer patients learn about research studies outside of the clinical environment, including websites, print and online advertisements, and interpersonal interactions. When cancer patients share credible information about clinical trials, they also frequently help clarify misunderstandings that may exist in their social networks. The present study investigated how an interactive tailored information aid on clinical trial participation motivated patients' information sharing behaviors. In this study of 312 cancer patients and survivors, an interactive tailored information aid improved patients' likelihood of sharing online and offline information more than a non-interactive tool. Information sharing was directly predicted by cognitive absorption and perceived visual informativeness. In addition, perceived utility and ease of use indirectly impact information sharing positively through the antecedent factors of user engagement and design esthetics. Education level further moderated this effect; information sharing was higher among patients with more education. The implications of these findings are discussed and recommendations for future research are provided.

Improving knowledge and decision readiness to participate in cancer clinical trials: Effects of a plain language decision aid for minority cancer survivors.

OBJECTIVE: To evaluate the impact of a web-based, plain language decision aid (CHOICES DA) on minority cancer survivors' knowledge of cancer clinical trials (CCTs), readiness for making decisions about clinical trial participation, and willingness to participate in a clinical trial. METHODS: Participants were 64 Black and Hispanic cancer survivors from Miami, Florida. In a single arm intervention study, participants completed self-report assessments of CCT knowledge, decision readiness regarding clinical trial participation, and willingness to participate at three time points. RESULTS: Black and Hispanic participants did not differ on demographic characteristics. Post-test and follow-up measures of CCT knowledge and decision readiness were significantly greater than pre-test measures for the sample overall, and for Black and Hispanic participants separately. Few significant differences were observed between Black and Hispanic participant outcomes at each survey time point, and willingness to participate did not change overall and for either group independently. CONCLUSIONS: Reviewing the CHOICES DA was associated with significantly improved knowledge and decision readiness to participate in a CCT immediately and at 2-week follow-up. PRACTICAL IMPLICATIONS: These findings suggest that CHOICES DA may support informed decision making about CCT participation within an acute, yet clinically relevant window of time for minority cancer patients who are substantially under-represented in cancer research.

Gender disparities in lung cancer survival from an enriched Florida population-based cancer registry.

BACKGROUND: Previous studies have revealed gender disparities in lung cancer survivorship, but comprehensive inclusion of clinical/individual variables which affect outcomes is underreported. We utilized the Florida Data Cancer System (FCDS) to examine associations between gender and lung cancer survivorship while controlling for prognostic variables on a large population-based scale. METHODS: A retrospective cohort analysis utilizing the FCDS, linked to Florida Agency for Health Care Administration and US Census Bureau tracts for patients diagnosed with primary lung cancer (n = 165,465) from 1996 to 2007. Primary outcome measures included median survival time and mortality. Multivariable Cox regression models, independent sample T-tests, and descriptive statistics were utilized with significance defined as p < 0.05. RESULTS: 165,465 cases were analyzed revealing 44.3% females and 55.7% males. The majority of patients were white/Caucasian, males, middle-high socioeconomic status, lived in urban areas, and geriatric age. Females had longer median survival compared to males (9.6 vs 7.1 months). Multivariable analyses showed that women had better survival after controlling for sociodemographic, clinical, and comorbidity covariates. Males had higher risk of mortality than females (aHR = 1.17, 95%CI 1.14-1.19, p < 0.01). CONCLUSIONS: Individuals of higher socioeconomic status experienced greater survivorship compared to those of lower socioeconomic status. Women experienced significantly better survival for lung cancer at multiple time frames after controlling for covariates compared to men. Interventions aimed at public education and access to high-quality healthcare are needed to ameliorate socioeconomic and gender-based disparities in lung cancer survivorship. Future studies should investigate gender differences in lung cancer while incorporating individual socioeconomic status and treatment received.

Comparing Methods of Recruiting Spanish-Preferring Smokers in the United States: Findings from a Randomized Controlled Trial.

BACKGROUND: There is a pressing need to address the unacceptable disparities and underrepresentation of racial and ethnic minority groups, including Hispanics or Latinxs, in smoking cessation trials. OBJECTIVE: Given the lack of research on recruitment strategies for this population, this study aims to assess effective recruitment methods based on enrollment and cost. METHODS: Recruitment and enrollment data were collected from a nationwide randomized controlled trial (RCT) of a Spanish-language smoking cessation intervention (N=1417). The effectiveness of each recruitment strategy was evaluated by computing the cost per participant (CPP), which is the ratio of direct cost over the number enrolled. More effective strategies yielded lower CPPs. Demographic and smoking-related characteristics of participants recruited via the two most effective strategies were also compared (n=1307). RESULTS: Facebook was the most effective method (CPP=US $74.12), followed by TV advertisements (CPP=US $191.31), whereas public bus interior card advertising was the least effective method (CPP=US $642.50). Participants recruited via Facebook had lower average age (P=.008) and had spent fewer years in the United States (P<.001). Among the participants recruited via Facebook, a greater percentage of individuals had at least a high school education (P<.001) and an annual income above US $10,000 (P<.001). In addition, a greater percentage of individuals were employed (P<.001) and foreign born (P=.003). In terms of subethnicity, among the subjects recruited via Facebook, a lower percentage of individuals were of Mexican origin (P<.001) and a greater percentage of individuals were of Central American (P=.02), South American (P=.01), and Cuban (P<.001) origin. CONCLUSIONS: Facebook was the most effective method for recruiting Hispanic or Latinx smokers in the United States for this RCT. However, using multiple methods was necessary to recruit a more diverse sample of Spanish-preferring Hispanic or Latinx smokers.

Brief Education and a Conjoint Valuation Survey May Reduce Decisional Conflict Regarding Lung Cancer Screening.

Background. Recent data and policy decisions have led to the availability of lung cancer screening (LCS) for individuals who are at increased risk of developing lung cancer. In establishing implementation policies, the US Preventive Services Task Force recommended and the Centers for Medicare and Medicaid Services required that individuals who meet eligibility criteria for LCS receive a patient counseling and shared decision-making consultation prior to LCS. Methods. This study evaluated the potential of a values clarification/preference elicitation exercise and brief educational intervention to reduce decisional conflict regarding LCS. Participants (N = 210) completing a larger online survey responded to a measure of decisional conflict prior to and following administration of a conjoint survey and brief educational narrative about LCS. The conjoint survey included 22 choice sets (two of which were holdout cards), incorporating 5 attributes with 17 levels. Results. Results pertaining to changes in decisional conflict showed that participants reported statistically significantly and clinically meaningful reductions in decisional conflict following administration of the brief educational narrative and conjoint survey across the total score (Δ = 29.30; d = 1.09) and all four decisional conflict subscales: Uncertainty (Δ = 27.75; d = 0.73), Informed (Δ = 35.32; d = 1.11), Values Clarity (Δ = 31.82; d = 0.85), and Support (Δ = 18.78; d = 0.66). Discussion. While the study design precludes differentiating the effects of the brief educational narrative and the conjoint survey, data suggest that these tools offer a reasonable approach to clarifying personal beliefs and perspectives regarding LCS participation. Given the complicated nature of LCS decisions and recent policies advocating informed and shared decision-making approaches, conjoint surveys should be evaluated as one of the tools that could help individuals make choices about LCS participation.