Mainstreaming in parallel with ovarian cancer tumor testing to improve genetic testing uptake.

OBJECTIVES: Although genetic testing (GT) is universally recommended for patients with epithelial ovarian cancer (EOC), rates are low (34%). In 1/2019, we implemented mainstreaming-GT in parallel with tumor testing via MSK-IMPACT within oncology clinics. We sought to determine GT rates pre/post-mainstreaming and patient characteristics associated with GT. METHODS: Patients with newly diagnosed EOC seen at our institution from 7/1/2015-3/31/2022 were included. Clinical data were abstracted including social determinants of health (SDOH) variables, race/ethnicity, marital status, insurance, language, comorbidities, employment, and Yost index, a measure of socioeconomic status. GT rates were calculated overall and pre-/post-mainstreaming (1/2019). Logistic regression models were fit to identify variables associated with GT. RESULTS: Of 1742 patients with EOC, 1591 (91%) underwent GT. Rates of GT increased from 87% to 95% after mainstreaming (p < 0.001). Among 151 patients not undergoing GT, major reasons were lack of provider recommendation (n = 76, 50%) and logistical issues (n = 38, 25%) with few declining (n = 14, 9%) or having medical complications preventing GT (n = 7, 4.6%). High-grade serous histology, advanced stage (III/IV), and having a spouse/partner were associated with increased GT uptake (p < 0.01). Among SDOH variables, there were no differences by insurance, Yost score, language, comorbidities, employment, or race/ethnicity. In multivariable models, likelihood of GT increased with mainstreaming, even after adjustment for histology, stage, and marital status (OR 3.77; 95% CI: 2.56-5.66). CONCLUSIONS: Mainstreaming increased the likelihood of GT in patients with EOC. We found lower testing rates in patients without partners/spouses, non-high-grade serous histology, and early-stage disease, representing potential areas for future interventions.

An orientation to the US National Cancer plan for the research community.

The US National Cancer Act of 1971 designated the director of the National Cancer Institute as responsible for coordinating federal agencies and nonfederal organizations to make progress against cancer. As part of her role, the immediate past director of the National Cancer Institute (MMB) led the development of a National Cancer Plan that was formally released on April 3, 2023. The plan includes 8 aspirational goals "to achieve a society where every person with cancer lives a full and active life and to prevent most cancers so that few people need to face this diagnosis." Research findings provide a foundation for each goal, and research gaps are included in the strategies for meeting each goal. The President's Cancer Panel, also created by the National Cancer Act, conducted an initial assessment of progress toward the plan goals by hearing from 12 organizations at a virtual public meeting on September 7, 2023. The purpose of this commentary is to orient the scientific community to the plan and call attention to related knowledge gaps that could benefit from research.

Integration of Total Worker Health ® Training for Occupational Health and Safety Professionals With Efforts to Promote Worker Health, Safety, and Well-being in Mexico.

OBJECTIVE: We sought to test whether a 2-week Total Worker Health (TWH) training mapped to TWH education competencies could be administered to a Mexican audience of occupational safety and health professionals and could lead to positive changes to knowledge and behaviors. METHODS: This study used robust program evaluation methods collected before and after each of the nine training days and at the end of the course. RESULTS: Overall course quality received a mean score of 4.6 (SD = 0.6) and 98.8% of participants agreed that their TWH knowledge increased. All participants intended to make at least one change to their professional practice, most frequently helping companies assess their organizational culture to support health, safety, and well-being. CONCLUSIONS: This TWH training was well received and led to positive self-reported increase in knowledge and abilities to influence workers' health, safety, and well-being.

Pathogenic germline variants in patients with endometrial cancer of diverse ancestry.

BACKGROUND: Racial disparities in outcomes exist in endometrial cancer (EC). The contribution of ancestry-based variations in germline pathogenic variants (gPVs) is unknown. METHODS: Germline assessment of ≥76 cancer predisposition genes was performed in patients with EC undergoing tumor-normal Memorial Sloan Kettering Cancer Center Integrated Mutation Profiling of Actionable Cancer Targets sequencing from January 1, 2015 through June 30, 2021. Self-reported race/ethnicity and Ashkenazi Jewish ancestry data classified patients into groups. Genetic ancestry was inferred from Memorial Sloan Kettering Cancer Center Integrated Mutation Profiling of Actionable Cancer Targets. Rates of gPV and genetic counseling were compared by ancestry. RESULTS: Among 1625 patients with EC, 216 (13%) had gPVs; 15 had >1 gPV. Rates of gPV varied by self-reported ancestry (Ashkenazi Jewish, 40/202 [20%]; Asian, 15/124 [12%]; Black/African American (AA), 12/171 [7.0%]; Hispanic, 15/124 [12%]; non-Hispanic (NH) White, 129/927 [14%]; missing, 5/77 [6.5%]; p = .009], with similar findings by genetic ancestry (p < .001). We observed a lower likelihood of gPVs in patients of Black/AA (odds ratio [OR], 0.44; 95% CI, 0.22-0.81) and African (AFR) ancestry (OR, 0.42; 95% CI, 0.18-0.85) and a higher likelihood in patients of Ashkenazi Jewish genetic ancestry (OR, 1.62; 95% CI; 1.11-2.34) compared with patients of non-Hispanic White/European ancestry, even after adjustment for age and molecular subtype. Somatic landscape influenced gPVs with lower rates of microsatellite instability-high tumors in patients of Black/AA and AFR ancestry. Among those with newly identified gPVs (n = 114), 102 (89%) were seen for genetic counseling, with lowest rates among Black/AA (75%) and AFR patients (67%). CONCLUSIONS: In those with EC, gPV and genetic counseling varied by ancestry, with lowest rates among Black/AA and AFR patients, potentially contributing to disparities in outcomes given implications for treatment and cancer prevention. PLAIN LANGUAGE SUMMARY: Black women with endometrial cancer do worse than White women, and there are many reasons for this disparity. Certain genetic changes from birth (mutations) can increase the risk of cancer, and it is unknown if rates of these changes are different between different ancestry groups. Genetic mutations in 1625 diverse women with endometrial cancer were studied and the lowest rates of mutations and genetic counseling were found in Black and African ancestry women. This could affect their treatment options as well as their families and may make disparities worse.

Germline Pathogenic Variants and Genetic Counseling by Ancestry in Patients With Epithelial Ovarian Cancer.

PURPOSE: To evaluate rates of germline pathogenic/likely pathogenic variants (PVs) and genetic counseling by ancestry in patients with epithelial ovarian cancer (EOC). METHODS: Patients with pathologically confirmed EOC who underwent clinical tumor-normal sequencing from January 1, 2015, to December 31, 2020, inclusive of germline analysis of ≥76 genes were included. Patients with newly identified PVs were referred for Clinical Genetics Service (CGS) counseling. Ancestry groups were defined using self-reported race/ethnicity and Ashkenazi Jewish (AJ) heritage. Genetic ancestry was inferred computationally using validated algorithms. Logistic regression models were built. RESULTS: Of 1,266 patients, self-reported ancestry (AJ, 17%; Asian, 10%; Black/African American, 5.4%; Hispanic, 6.2%; non-Hispanic White, 57%; other, 0.16%; unknown, 4.0%) correlated with genetic ancestry (AJ ancestry, 18%; admixed, 10%; African, 4%; East Asian [EAS], 6%; European, 56%; Native American, 0.2%; South Asian [SAS], 4%; unknown, 2%). Germline PVs were observed in 313 (25%) patients, including 195 (15%) with PVs in EOC-associated genes. Those with PVs were younger at diagnosis (59 v 62 years; P < .001) and more likely to have high-grade serous ovarian cancer (83% v 72%; P = .009). PV prevalence varied between ancestry groups (P < .001), with highest rates in the AJ (39.9%) and Asian (26.5%) groups and similar rates (>10%) across other ancestry groups. Use of genetic ancestry demonstrated similar findings and further characterized high rates of PV in EAS/SAS groups. Younger age, high-grade serous histology, and self-reported AJ or Asian ancestry were associated with PV in an EOC-associated gene. Rates of CGS counseling for newly identified PVs were high (80%) across ancestry groups. CONCLUSION: Rates of PV, particularly in EOC-associated genes, were high regardless of ancestry, with similar rates of counseling between groups, emphasizing the importance of universal genetic testing in all patients with EOC.

Molecular Characterization of Endometrial Carcinomas in Black and White Patients Reveals Disparate Drivers with Therapeutic Implications.

Although the incidence of endometrial carcinoma (EC) is similar in Black and White women, racial disparities are stark, with the highest mortality rates observed among Black patients. Here, analysis of 1,882 prospectively sequenced ECs using a clinical FDA-authorized tumor-normal panel revealed a significantly higher prevalence of high-risk histologic and molecular EC subtypes in self-identified Black (n = 259) compared with White (n = 1,623) patients. Clinically actionable alterations, including high tumor mutational burden/microsatellite instability, which confer benefit from immunotherapy, were less frequent in ECs from Black than from White patients. Ultramutated POLE molecular subtype ECs associated with favorable outcomes were rare in Black patients. Results were confirmed by genetic ancestry analysis. CCNE1 gene amplification, which is associated with aggressive clinical behavior, was more prevalent in carcinosarcomas occurring in Black than in White patients. ECs from Black and White patients display important differences in their histologic types, molecular subtypes, driver genetic alterations, and therapeutic targets. SIGNIFICANCE: Our comprehensive analysis of prospectively clinically sequenced ECs revealed significant differences in their histologic and molecular composition and in the presence of therapeutic targets in Black versus White patients. These findings emphasize the importance of incorporating diverse populations into molecular studies and clinical trials to address EC disparities. This article is featured in Selected Articles from This Issue, p. 2293.

The Relationship Between Stress and Sleep Sufficiency in the Context of Varied Workplace Social Support.

OBJECTIVE: Sufficient sleep is essential for well-being. We examined the relationship between work-related social support, work stress, and sleep sufficiency, predicting that workers with higher social support would report higher sleep sufficiency across varying levels of work stress. METHODS: The data set analyzed in the present study included 2213 workers from approximately 200 small (<500 employees) businesses in high, medium, and low hazard industries across Colorado. RESULTS: Perceived social support variables moderated the relationship between work stress and sleep sufficiency such that employees reporting higher levels of social support reported higher sleep sufficiency when work stress was low or moderate but not high. CONCLUSIONS: Although preventing work stress is optimal, in cases where employers cannot apply primary interventions to prevent stress (eg, eliminating/reducing night shifts), employers should attempt to increase social support or other more relevant resources for employees.

Patient-reported symptoms after minimally invasive hysterectomy and association with postoperative complications.

OBJECTIVE: To describe patient-reported postoperative symptoms and to evaluate the use of digital symptom tracking and alerts to detect postoperative complications. METHODS: We retrospectively reviewed patients who underwent a minimally invasive hysterectomy and enrolled in our Recovery Tracker program from 4/5/17-12/31/21. The Recovery Tracker is an at-home virtual tool used to track patient-reported postoperative symptoms for 10 days. Predefined thresholds for "red" and "yellow" alerts are based on symptom severity and timing. Data on patient demographics, surgery, and postoperative course were collected to evaluate the association of alerts with complications and compare outcomes of patients who did/did not enroll in the program. RESULTS: Of 2362 eligible patients, 1694 (71.7%) enrolled in the Recovery Tracker program. Pain was the most severe symptom, followed by fatigue. Eighty-seven patients experienced 102 complications (5.1% complication rate) and 32 experienced 39 grade ≥ 2 complications (1.9% severe complication rate). Excluding complications that occurred prior to Recovery Tracker use, 1673 patients experienced 28 grade ≥ 2 complications. Of 345 patients (20.6%) who triggered a red alert, 13 (3.8%) had a grade ≥ 2 complication. Of 1328 patients (79.4%) with no red alerts, 15 (1.13%) had a grade ≥ 2 complication. Relative risk of a grade ≥ 2 complication if a red alert was triggered was 3.25 (95% CI: 1.6-6.9, P = .002). Rate of severe complications was significantly higher among patients who did not use the tool (3.3% vs 1.9%; P = .04). CONCLUSIONS: The Recovery Tracker tool may assist in early identification of postoperative symptoms after minimally invasive hysterectomy.

Pilot Randomized Trial of a Three Times Weekly Heparin Flushing Intervention in Children, Adolescents, and Young Adults With Cancer With Tunneled Central Venous Catheters.

Background: Children and adolescents with cancer often undergo aggressive treatment and receive supportive care requiring a long-term tunneled central venous catheter (TCVC). Regular flushing promotes TCVC patency when not in use (i.e., noninfusing). However, TCVC flushing guidelines and the current practice of daily flushing are not based on high-quality evidence. Few studies have compared the effect of less frequent flushing on TCVC patency. The purpose of this study was to evaluate the feasibility of a three times weekly heparin flushing intervention, as compared to daily heparin flushing, in children and adolescents and young adults (AYAs) with noninfusing TCVCs. Methods: Twenty children and AYAs were randomized to one of two groups, standard of care (SOC) (i.e., daily heparin flushing) or intervention (three times weekly heparin flushing) for 8 weeks. Feasibility data (recruitment, retention, acceptability, TCVC patency, and complications) were analyzed descriptively. Results: Twenty of 22 eligible patients were enrolled in the study (90% recruitment rate). Four participants discontinued the study early due to TCVC removal (20% attrition rate). One participant in each group had their TCVC removed due to a central line-associated bloodstream infection, one SOC group participant had their TCVC removed due to damage, and one intervention group participant had their TCVC removed due to discontinuation of treatment. No participants were withdrawn for safety concerns or because they did not find the protocol acceptable. Conclusions: It is feasible to conduct a large-scale randomized controlled trial to investigate a three times weekly heparin flushing intervention in children and AYAs with TCVCs.

Genetic Ancestry Correlates with Somatic Differences in a Real-World Clinical Cancer Sequencing Cohort.

Accurate ancestry inference is critical for identifying genetic contributors of cancer disparities among populations. Although methods to infer genetic ancestry have historically relied upon genome-wide markers, the adaptation to targeted clinical sequencing panels presents an opportunity to incorporate ancestry inference into routine diagnostic workflows. We show that global ancestral contributions and admixture of continental populations can be quantitatively inferred using markers captured by the MSK-IMPACT clinical panel. In a pan-cancer cohort of 45,157 patients, we observed differences by ancestry in the frequency of somatic alterations, recapitulating known associations and revealing novel associations. Despite the comparable overall prevalence of driver alterations by ancestry group, the proportion of patients with clinically actionable alterations was lower for African (30%) compared with European (33%) ancestry. Although this result is largely explained by population-specific cancer subtype differences, it reveals an inequity in the degree to which different populations are served by existing precision oncology interventions. SIGNIFICANCE: We performed a comprehensive analysis of ancestral associations with somatic mutations in a real-world pan-cancer cohort, including >5,000 non-European individuals. Using an FDA-authorized tumor sequencing panel and an FDA-recognized oncology knowledge base, we detected differences in the prevalence of clinically actionable alterations, potentially contributing to health care disparities affecting underrepresented populations. This article is highlighted in the In This Issue feature, p. 2483.

Disparities in cancer genetics care by race/ethnicity among pan-cancer patients with pathogenic germline variants.

BACKGROUND: Germline risk assessment is increasing as part of cancer care; however, disparities in subsequent genetic counseling are unknown. METHODS: Pan-cancer patients were prospectively consented to tumor-normal sequencing via custom next generation sequencing panel (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets) inclusive of germline analysis of ≥76 genes from January 2015 through December 2019 (97.5% research nonbillable) with protocol for genetics referral. Rates of pathogenic/likely pathogenic germline variants (PVs) and downstream counseling were compared across ancestry groups (mutually exclusive groups based on self-reported race/ethnicity and Ashkenazi Jewish [AJ] heritage) using nonparametric tests and multivariable logistic regression models. RESULTS: Among 15,775 patients (59.6%, non-Hispanic [NH]-White; 15.7%, AJ; 20.5%, non-White [6.9%, Asian; 6.8%, Black/African American (AA); 6.7%, Hispanic; 0.1%, Other], and 4.2%, unknown), 2663 (17%) had a PV. Non-White patients had a lower PV rate (n = 433, 13.4%) compared to NH-Whites (n = 1451, 15.4%) and AJ patients (n = 683, 27.6%), p < .01, with differences in mostly moderate and low/recessive/uncertain penetrance variants. Among 2239 patients with new PV, 1652 (73.8%) completed recommended genetic counseling. Non-White patients had lower rates of genetic counseling (67.7%) than NH-White (73.7%) and AJ patients (78.8%), p < .01, with lower rates occurring in Black/AA (63%) compared to NH-White patients, even after adjustment for confounders (odds ratio, 0.60; 95% confidence interval, 0.37-0.97; p = .036). Non-White, particularly Black/AA and Asian, probands had a trend toward lower rates and numbers of at-risk family members being seen for counseling/genetic testing. CONCLUSIONS: Despite minimizing barriers to genetic testing, non-White patients were less likely to receive recommended cancer genetics follow-up, with potential implications for oncologic care, cancer risk reduction, and at-risk family members. LAY SUMMARY: Genetic testing is becoming an important part of cancer care, and we wanted to see if genetics care was different between individuals of different backgrounds. We studied 15,775 diverse patients with cancer who had genetic testing using a test called MSK-IMPACT that was covered by research funding. Clinically important genetic findings were high in all groups. However, Black patients were less likely to get recommended counseling compared to White patients. Even after removing many roadblocks, non-White and especially Black patients were less likely to get recommended genetics care, which may affect their cancer treatments and families.

Demographic shifts associated with implementation of evidence-based guidelines for ovarian conservation in patients with endometrioid endometrial cancer.

OBJECTIVE: In 2018, evidence-based surgical guidelines were introduced to identify appropriate patients with low-grade endometrioid endometrial cancer for ovarian conservation. We sought to identify trends and demographic shifts associated with guideline implementation. METHODS: We identified women treated for endometrioid endometrial cancer at our institution from January 2010 to June 2021. Eligibility criteria included age ≤50 years, normal-appearing ovaries on preoperative imaging, no family history of hereditary breast and ovarian cancer syndrome or Lynch syndrome, and no hormone receptor-positive malignancy. Trends in ovarian conservation were examined with the Cochran-Armitage trend test or in a logistic regression model. Associations between ovarian conservation and clinicodemographic factors before and after guideline implementation were compared using Wilcoxon rank-sum and Fisher's exact tests. RESULTS: Of 420 women ≤50 years of age undergoing surgery for endometrioid endometrial cancer, 355 (85%) met the criteria for ovarian conservation-267 (75%) before and 88 (25%) after guideline implementation. Median patient age was 45 years (range 25-50); 62% were non-Hispanic White, 10% Hispanic White, 8% non-Hispanic Black, 0% Hispanic Black, and 20% Asian. Patients were significantly more likely to choose ovarian conservation after (48%) compared with before guideline implementation (21%) (p<0.001). Pre-guidelines, non-Hispanic White women were less likely to elect for ovarian conservation (12%) compared with non-Hispanic Black, Asian, or Hispanic White women (28%) (p=0.002). Similarly, older women were less likely to elect for ovarian conservation compared with younger women (p<0.001). There were no differences by obesity (p=0.68), marital status (p=0.86), or insurance (p=0.89). Post-guidelines, there were no differences in ovarian conservation between non-Hispanic White women (36%) and non-Hispanic Black, Asian, or Hispanic White women (50%) (p=0.56). Older women were still less likely to elect for ovarian conservationcompared with younger women (p<0.001). CONCLUSIONS: After guideline implementation, ovarian conservation increased and uptake disparities across demographic groups decreased.

Small + Safe + Well: lessons learned from a Total Worker Health® randomized intervention to promote organizational change in small business.

BACKGROUND: Leadership commitment to worker safety and health is one of the most important factors when organizations develop and implement a Total Worker Health® approach. We aimed to assess the effectiveness of a Total Worker Health ("TWH") leadership development program that targeted owners and other senior-level leadership positions on changing organizational and worker outcomes from baseline to one-year later. METHODS: The Small + Safe + Well study included small businesses from a variety of industries in the state of Colorado, USA that were participating in Health Links™. We designed a randomized waitlisted control comparison design (RCT) to evaluate the added benefit of a TWH leadership development program. An employer assessment tool was used to assess TWH policies and programs, and an employee health and safety survey was used to assess safety leadership and health leadership practices, safety climate and health climate, safety behaviors and health behaviors, and well-being. We used a linear mixed model framework with random effects for business and employee to assess the impact of intervention on the outcomes of interest. RESULTS: Thirty-six businesses (37% retention) and 250 employees (9% retention) met the RCT study inclusion criteria and were included in the analysis. Businesses improved their TWH policies and programs score from baseline to one-year later, regardless of leadership intervention group assignment. Neither intervention group demonstrated improvements in employee-reported outcomes. CONCLUSIONS: This study sought to address a gap in the literature regarding small business senior leadership development for TWH. Our study demonstrates many of the challenges of conducting studies focused on organizational change in workplaces, specifically in small businesses. When designing TWH intervention studies, researchers should consider how to best engage small business leaders in interventions and implementations early on, as well as methods that are well matched to measuring primary and secondary outcomes longitudinally. Future research is needed to test the feasibility and sustainability of TWH interventions in small business. TRIAL REGISTRATION: The trial was retrospectively registered with ClinicalTrials.gov ( ID U19OH011227 ).

Gynecologic Survivorship Tool: Development, Implementation, and Symptom Outcomes.

PURPOSE: To describe the development and implementation of a new digital health clinical tool (Gynecologic Survivorship Tool [GST]) for symptom management of women surgically treated for gynecologic cancer; to assess its feasibility; and to conduct a retrospective review of the data. MATERIALS AND METHODS: The GST was developed on the basis of a comprehensive review of the literature, multidisciplinary expert opinion, and feedback from women with a history of gynecologic cancer. It is composed of 17 questions addressing six main categories-gynecologic health (abnormal bleeding/pain), lymphedema, vaginal/vulvar dryness, sexual health, menopause (hot flushes/sleep difficulties), and bowel/urinary issues. An electronic version using the Memorial Sloan Kettering Cancer Center Engage platform was piloted in two clinics for patients with endometrial or cervical cancer. Health information was generated into clinical summaries and identified concerns for actionable response. Associations of symptom and survey time point were assessed by longitudinal models using generalized estimating equations. RESULTS: From January 1, 2019, to February 29, 2020, 3,357 GST assessments were assigned to 1,405 patients, with a 71% completion rate (90% within 5 minutes). Sixty-eight percent were performed at home via a patient portal, 32% at follow-ups using a clinic iPad. The most common symptoms were bowel problems, swelling/fluid, pain during examination, vaginal or vulvar dryness, and vaginal bleeding. Implementation challenges included improving patient compliance and ensuring that reports were reviewed by all clinical teams. We developed screening e-mails detailing patients whose assessments were due, planned training sessions for multidisciplinary teams, and incorporated feedback on methods for reviewing symptoms reports. CONCLUSION: The GST demonstrated feasibility, a high completion rate, and minimal time commitment. It was an effective electronic reporting mechanism for patients, enabling the medical team to develop specific strategies for alleviating bothersome symptoms during follow-up.

Leveraging an Implementation Science Framework to Measure the Impact of Efforts to Scale Out a Total Worker Health® Intervention to Employers.

The role of dissemination and implementation (D&I) science is critical to the translation of Total Worker Health® into practice and to the success of interventions in addressing current and future implications for worker safety, health, and well-being. D&I frameworks can guide researchers to design Total Worker Health ("TWH") delivery approaches that use flexible implementation strategies to implement the core components of programs for employers with varying contextual factors, including small/mid/large-sized businesses and different industry types. To date, there have been very few examples of applying implementation frameworks for the translation and delivery of interventions into organizational settings that require adoption and implementation at the business level to benefit the working individuals. We present a TWH case study, Health Links™, to illustrate an approach to applying an existing implementation framework, RE-AIM, to plan, design, build, and then evaluate TWH implementation strategies. Our case study also highlights key concepts for scaling-out TWH evidence-based interventions where they are implemented in new workplace settings, new delivery systems, or both. Our example provides strong support of key implementation planning constructs including early and consistent stakeholder engagement, tailored messaging and marketing, flexibility, and adaptations in implementation strategies to maximize adoption, implementation, and maintenance among participating businesses.

Patient-reported benefit from proposed interventions to reduce financial toxicity during cancer treatment.

INTRODUCTION: Financial toxicity is common and pervasive among cancer patients. Research suggests that gynecologic cancer patients experiencing financial toxicity are at increased risk for engaging in harmful cost-coping strategies, including delaying/skipping treatment because of costs, or forsaking basic needs to pay medical bills. However, little is known about patients' preferences for interventions to address financial toxicity. METHODS: Cross-sectional surveys to assess financial toxicity [Comprehensive Score for Financial Toxicity (COST)], cost-coping strategies, and preferences for intervention were conducted in a gynecologic cancer clinic waiting room. Associations with cost-coping were determined using multivariate modeling. Unadjusted odds ratios (ORs) explored associations between financial toxicity and intervention preferences. RESULTS: Among 89 respondents, median COST score was 31.9 (IQR: 21-38); 35% (N = 30) scored < 26, indicating they were experiencing financial toxicity. Financial toxicity was significantly associated with cost-coping (adjusted OR = 3.32 95% CI: 1.08, 14.34). Intervention preferences included access to transportation vouchers (38%), understanding treatment costs up-front (35%), minimizing wait times (33%), access to free food at appointments (25%), and assistance with minimizing/eliminating insurance deductibles (23%). In unadjusted analyses, respondents experiencing financial toxicity were more likely to select transportation assistance (OR = 2.67, 95% CI: 1.04, 6.90), assistance with co-pays (OR = 9.17, 95% CI: 2.60, 32.26), and assistance with deductibles (OR = 12.20, 95% CI: 3.47, 43.48), than respondents not experiencing financial toxicity. CONCLUSIONS: Our findings confirm the presence of financial toxicity in gynecologic cancer patients, describe how patients attempt to cope with financial hardship, and provide insight into patients' needs for targeted interventions to mitigate the harm of financial toxicity.

Risk factors for financial toxicity in patients with gynecologic cancer.

BACKGROUND: The cost of cancer care is high and rising. Evidence of increased patient cost burden is prevalent in the medical literature and has been defined as "financial toxicity," the financial hardship and financial concerns experienced by patients because of a disease and its related treatments. With targeted therapies and growing out-of-pocket costs, patient financial toxicity is a growing concern among patients with gynecologic cancer. OBJECTIVE: This study aimed to determine the prevalence of financial toxicity and identify its risk factors in patients with gynecologic cancer treated at a large cancer center using objective data. STUDY DESIGN: Using institutional databases, we identified patients with gynecologic cancer treated from January 2016 to December 2018. Patients with a preinvasive disease were excluded. Financial toxicity was defined according to institutionally derived metrics as the presence of ≥1 of the following: ≥2 bills sent to collections, application or granting of a payment plan, settlement, bankruptcy, financial assistance program enrollment, or a finance-related social work visit. Clinical characteristics were gathered using a 2-year look-back from the time of the first financial toxicity event or a randomly selected treatment date for those not experiencing toxicity. Risk factors were assessed using chi-squared tests. All significant variables on univariate analysis were included in the logistic regression model. RESULTS: Of the 4655 patients included in the analysis, 1155 (25%) experienced financial toxicity. In the univariate analysis, cervical cancer (35%), stage 3 or 4 disease (24% and 30%, respectively), younger age (35% for age <30 years), nonpartnered marital status (31%), Black (45%) or Hispanic (37%) race and ethnicity, self-pay (48%) or commercial insurance (30%), clinical trial participation (31%), more imaging studies (39% for ≥9), ≥1 emergency department visit (36%), longer inpatient stays (36% for ≥20 days), and more outpatient clinician visits (41% for ≥20 visits) were significantly associated with financial toxicity (P<.01). In multivariate analysis, younger age, nonpartnered marital status, Black and Hispanic race and ethnicity, commercial insurance, more imaging studies, and more outpatient physician visits were significantly associated with financial toxicity. CONCLUSION: Financial toxicity is an increasing problem for patients with gynecologic cancer. Our analysis, using objective measures of financial toxicity, has suggested that demographic factors and healthcare utilization metrics may be used to proactively identify at-risk patients for financial toxicity.

Total Worker Health® and Small Business Employee Perceptions of Health Climate, Safety Climate, and Well-Being during COVID-19.

The COVID-19 pandemic created workplace challenges for employee safety and health, especially in small enterprises. We used linear mixed-effects regression to examine changes in health climate, safety climate, and worker well-being, prior to the pandemic and at two timepoints during it. We also examined whether employees at organizations that had received a TWH leadership development intervention prior to COVID-19 would better maintain pre-pandemic perceptions of climates and well-being. The final study cohort consisted of 261 employees from 31 organizations. No differences were observed in mean outcome scores between the leadership intervention groups at any of the survey timepoints. We combined intervention groups to examine the difference across timepoints. Perceptions of health and safety climates remained stable across all timepoints. However, employee well-being scores declined between the pre-pandemic period and subsequent COVID-19 timepoints. These findings suggest that while small organizations continued to be viewed as supporting employees' health and safety over the course of the pandemic, well-being scores declined, indicating that other factors contributed to decreased well-being. The findings from this study have implications for small business leaders as they navigate the impact of the COVID-19 pandemic on the health, safety, and well-being on their organizations and employees.

A pilot study of changes in Total Worker Health® policies and programs and associated changes in safety and health climates in small business.

BACKGROUND: There is little longitudinal research on whether changes to Total Worker Health® (TWH) policies and programs are associated with changes in health climate and safety climate. We hypothesize that as TWH policies and programs change, employees will report changes in safety climate and health climate from baseline to 1 year. METHODS: Twenty-five diverse small businesses and their employees participated in assessments completed approximately 1 year apart. The exposures of interest, TWH policies and programs, were measured using the business-level Healthy Workplace Assessment™ which collects information on six benchmarks. The outcomes of interest, employee perceptions of safety climate and health climate, were measured via an employee survey. We employed paired t-tests and simple linear regression to assess change over a 1-year period. RESULTS: The mean Healthy Workplace Assessment overall score changed by 11.3 points (SD = 11.8) from baseline to Year 1. From baseline to Year 1, the mean scores of each benchmark changed in a positive direction within this sample. The mean safety climate score and health climate score changed by +0.1 points (SD = 0.2) and +0.1 points (SD = 6.4) from baseline to Year 1, respectively. The associations between changes in the overall Healthy Workplace Assessment score and health climate and safety climate scores were negligible [ß = 0.01 (95% confidence interval [CI]: 0.002, 0.02), and ß = 0.01 (95% CI: 0.002, 0.02), respectively]. CONCLUSION: Our study suggests that when small businesses improve upon their TWH policies and programs they experience marginal measurable improvements in employee perceptions of their workplace safety climate and health climate.