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BACKGROUND: Guidelines informing chemotherapy regimen selection are based on clinical trials with participants who do not necessarily represent general populations with breast cancer. Understanding who receives non-guideline regimens is important to understanding real-world chemotherapy administration and how it relates to patient outcomes. METHODS: Using data from the Optimal Breast Cancer Chemotherapy Dosing (OBCD) cohort study, based at Kaiser Permanente Northern California (2006-2019) and Kaiser Permanente Washington (2004-2015), we use logistic regression to examine the associations between patient characteristics and receipt of non-NCCN-guideline chemotherapy among 11,293 women with primary stage I-IIIA breast cancer receiving chemotherapy. RESULTS: Use of non-guideline regimens was strongly associated with several factors, including older age (OR≥80 vs 18-39: 5.25, 95%CI: 3.06-9.00)(p-trend=0.002) and human epidermal growth factor-2 status (ORHER2+ vs HER2-: 3.44; 95%CI: 3.06-3.87) and was less likely in women with larger tumor size (OR>5cm vs 0.1-≤0.5cm: 0.56; 95%CI: 0.36-0.87)(p-trend=0.01) and diagnosed in later years (OR2012-2019 vs 2005-2011: 0.80; 95%CI: 0.71-0.90). Factors associated varied by type of non-guideline regimen. For example, women with comorbidity and older age were more likely to receive non-guideline drug combinations in particular, while women with larger tumor size were less likely to receive non-guideline administration schedules. CONCLUSIONS: Non-guideline chemotherapy regimens are more likely in certain patient populations. IMPACT: These associations highlight that vulnerable patient populations may be less likely to receive guideline care and thus real-world studies are essential to understanding how the use of non-guideline regimens impacts patient outcomes in these groups.
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For patients with breast cancer, delays in chemotherapy initiation have been adversely associated with recurrence and survival. We evaluated patient-level factors associated with delayed chemotherapy initiation, from both diagnosis and surgery, in a community-based cohort of women with early-stage breast cancer. For the Optimal Breast Cancer Chemotherapy Dosing study, we identified a cohort of 34,109 women diagnosed with stage I-IIIA breast cancer at two U.S. integrated healthcare delivery systems between 2004 and 2019. We used logistic regression to calculate odds ratios (OR) and 95% confidence intervals (CI) to identify patient factors associated with delays in chemotherapy initiation after diagnosis (≥90 days) and surgery (≥60 days). Among 10,968 women receiving adjuvant chemotherapy, 21.1% experienced delays in chemotherapy initiation after diagnosis and 21.3% after surgery. Older age, non-Hispanic Black and Hispanic race and ethnicity, and ER+ and/or PR+ disease were associated with increased likelihood of delays to chemotherapy initiation after diagnosis and surgery. People diagnosed in 2012-2019 (vs. 2005-2011), with a higher grade and larger tumor size were less likely to experience delays. Other factors were associated with a higher likelihood of delays specifically from diagnosis (earlier stage, mastectomy vs. breast-conserving surgery), or surgery (higher comorbidity, increased nodal number). Women diagnosed with breast cancer who were at highest risk of progression and recurrence were less likely to experience delays in chemotherapy initiation after diagnosis and surgery. Understanding reasons for chemotherapy delays beyond patient factors may be potentially important to reduce risk of breast cancer recurrence and progression.
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PURPOSE: Clinical benefits result from electronic patient-reported outcome (ePRO) systems that enable remote symptom monitoring. Although clinically useful, real-time alert notifications for severe or worsening symptoms can overburden nurses. Thus, we aimed to algorithmically identify likely non-urgent alerts that could be suppressed. METHODS: We evaluated alerts from the PRO-TECT trial (Alliance AFT-39) in which oncology practices implemented remote symptom monitoring. Patients completed weekly at-home ePRO symptom surveys, and nurses received real-time alert notifications for severe or worsening symptoms. During parts of the trial, patients and nurses each indicated whether alerts were urgent or could wait until the next visit. We developed an algorithm for suppressing alerts based on patient assessment of urgency and model-based predictions of nurse assessment of urgency. RESULTS: 593 patients participated (median age = 64 years, 61% female, 80% white, 10% reported never using computers/tablets/smartphones). Patients completed 91% of expected weekly surveys. 34% of surveys generated an alert, and 59% of alerts prompted immediate nurse actions. Patients considered 10% of alerts urgent. Of the remaining cases, nurses considered alerts urgent more often when patients reported any worsening symptom compared to the prior week (33% of alerts with versus 26% without any worsening symptom, p = 0.009). The algorithm identified 38% of alerts as likely non-urgent that could be suppressed with acceptable discrimination (sensitivity = 80%, 95% CI [76%, 84%]; specificity = 52%, 95% CI [49%, 55%]). CONCLUSION: An algorithm can identify remote symptom monitoring alerts likely to be considered non-urgent by nurses, and may assist in fostering nurse acceptance and implementation feasibility of ePRO systems.
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Algoritmos , Medidas de Resultados Relatados pelo Paciente , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Neoplasias , Inquéritos e Questionários , AdultoRESUMO
Importance: The OlympiA trial found that 1 year of adjuvant olaparib therapy can improve distant disease-free survival and overall survival from early-stage breast cancer in patients with a germline BRCA1/2 mutation. However, olaparib, an oral poly-adenosine diphosphate ribose polymerase inhibitor, is estimated to cost approximately $14â¯000 per month in the US. Objective: To estimate the incremental cost-effectiveness of adjuvant olaparib compared with no olaparib in eligible patients. Design, Setting, and Participants: In an economic evaluation from a health care system perspective, the cost-effectiveness of adjuvant olaparib was analyzed using a Markov state-transition model. The model simulated costs and lifetime health outcomes of 42-year-old women with high-risk early-stage breast cancer and a known BRCA1/2 mutation who completed definitive primary therapy and neoadjuvant or adjuvant systemic therapy. The study was conducted from August 2021 to July 2023. The effectiveness of olaparib was based on the findings of the OlympiA randomized clinical trial, and other model parameters were identified from the literature. The model was calibrated to the 1-, 2-, 3-, and 4-year distant disease-free and overall survival observed in the OlympiA trial, and olaparib was assumed to reduce the risk of distant recurrence only in the first 4 years. Exposure: One year of adjuvant olaparib or no adjuvant olaparib. Main Outcome and Measure: Incremental cost-effectiveness ratio (ICER) in 2021 US dollars per quality-adjusted life-year (QALY) gained. All outcomes were discounted by 3% annually. Results: In the base case, adjuvant olaparib was associated with a 1.25-year increase in life expectancy and a 1.20-QALY increase at an incremental cost of $133â¯133 compared with no olaparib. The resulting ICER was approximately $111â¯000 per QALY gained. At a willingness-to-pay threshold of $150â¯000 per QALY, olaparib was cost-effective at its 2021 price and in more than 92% of simulations in probabilistic sensitivity analysis. The results were sensitive to assumptions about the effectiveness of olaparib and quality of life for patients with no disease recurrence. Conclusions and Relevance: In this study, from a US health care system perspective, adjuvant olaparib was a cost-effective option for patients with high-risk, early-stage breast cancer and a germline BRCA1/2 mutation.
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Neoplasias da Mama , Adulto , Feminino , Humanos , Proteína BRCA1/genética , Proteína BRCA2/genética , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/genética , Análise Custo-Benefício , Células Germinativas , Mutação , Recidiva Local de Neoplasia , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
PURPOSE: The 21-gene recurrence score (RS) assay predicts the recurrence risk and magnitude of chemotherapy benefit in patients with invasive breast cancer (BC). This study examined low-grade tumors yielding a high-risk RS and their outcomes.Kindly check the edit made in the article titleOk METHODS: We compared patients with grade 1 BC and a high-risk RS to those with low-risk RS. Histologic sections were reviewed and features reported to elevate the RS were noted, mainly biopsy cavity and reactive stromal changes (BXC). RESULTS: A total of 54 patients had high-risk RS (median RS of 28, range 26-36). On review, BXC were seen in all cases. Thirty BCs in this group also had low to negative PR. Treatment regimens included: chemoendocrine therapy (63%), endocrine therapy alone (31%) and no adjuvant therapy (6%). There were no additional breast cancer events over a median follow-up of 54.0 months (range 6.2 to 145.3). A total of 108 patients had low-risk RS (median RS of 7, range 0-9). BXC were seen in 47% of cases and none were PR negative. One patient had a recurrence at 64.8 months while the rest had no additional events over a median of 68.1 months (2.4 to 100). CONCLUSION: We provide further evidence that reactive stromal changes and/or low-PR scores enhance the elevation of the RS. A high-RS result in low grade, PR-positive BC may not reflect actual risk and any suspected discrepancies should be discussed with the management teams. Multigene testing results should be interpreted after correlation with pathologic findings to optimize patient care.
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Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/genética , Neoplasias da Mama/patologia , Receptores de Estrogênio/análise , Mama/patologia , Terapia Combinada , Intervalo Livre de Doença , Recidiva Local de Neoplasia/genética , Recidiva Local de Neoplasia/patologia , Prognóstico , Biomarcadores Tumorais/genéticaRESUMO
PURPOSE: Financial toxicity (FT) affects 20% of cancer survivors and is associated with poor clinical outcomes. No large-scale programs have been implemented to mitigate FT. We evaluated the effect of monthly FT screening as part of a larger patient-reported outcomes (PROs) digital monitoring intervention. METHODS: PRO-TECT (AFT-39) is a cluster-randomized trial of patients undergoing systemic therapy for metastatic cancer. Practices were randomly assigned 1:1 to digital symptom monitoring (PRO practices) or usual care (control practices). Digital monitoring consisted of between-visit online or automated telephone patient surveys about symptoms, functioning, and FT (single-item screening question from Functional Assessment of Chronic Illness Therapy-COmprehensive Score for financial Toxicity) for up to 1 year, with automated alerts sent to practice nurses for concerning survey scores. Clinical team actions in response to alerts were not mandated. The primary outcome of this planned secondary analysis was development or worsening of financial difficulties, assessed via the European Organisation for Research and Treatment of Cancer QLQ-C30 financial difficulties measure, at any time compared with baseline. A randomly selected subset of patients and nurses were interviewed about their experiences with the intervention. RESULTS: One thousand one hundred ninety-one patients were enrolled (593 PRO; 598 control) at 52 US community oncology practices. Overall, 30.2% of patients treated at practices that received the FT screening intervention developed, or experienced worsening of, financial difficulties, compared with 39.0% treated at control practices (P = .004). Patients and nurses interviewed stated that FT screening identified patients for financial counseling who otherwise would be reluctant to seek, or unaware of the availability of, assistance. CONCLUSION: In this report of a secondary outcome from a randomized clinical trial, FT screening as part of routine digital patient monitoring with PROs reduced the development, or worsening, of financial difficulties among patients undergoing systemic cancer therapy.
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Estresse Financeiro , Neoplasias , Humanos , Qualidade de Vida , Neoplasias/tratamento farmacológico , Neoplasias/complicações , Medidas de Resultados Relatados pelo PacienteRESUMO
AIMS: The most appropriate timing of exercise therapy to improve cardiorespiratory fitness (CRF) among patients initiating chemotherapy is not known. The effects of exercise therapy administered during, following, or during and following chemotherapy were examined in patients with breast cancer. METHODS AND RESULTS: Using a parallel-group randomized trial design, 158 inactive women with breast cancer initiating (neo)adjuvant chemotherapy were allocated to receive (1:1 ratio): usual care or one of three exercise regimens-concurrent (during chemotherapy only), sequential (after chemotherapy only), or concurrent and sequential (continuous) (n = 39/40 per group). Exercise consisted of treadmill walking three sessions/week, 20-50 min at 55%-100% of peak oxygen consumption (VO2peak) for ≈16 (concurrent, sequential) or ≈32 (continuous) consecutive weeks. VO2peak was evaluated at baseline (pre-treatment), immediately post-chemotherapy, and ≈16 weeks after chemotherapy. In intention-to-treat analysis, there was no difference in the primary endpoint of VO2peak change between concurrent exercise and usual care during chemotherapy vs. VO2peak change between sequential exercise and usual care after chemotherapy [overall difference, -0.88 mL O2·kg-1·min-1; 95% confidence interval (CI): -3.36, 1.59, P = 0.48]. In secondary analysis, continuous exercise, approximately equal to twice the length of the other regimens, was well-tolerated and the only strategy associated with significant improvements in VO2peak from baseline to post-intervention (1.74 mL O2·kg-1·min-1, P < 0.001). CONCLUSION: There was no statistical difference in CRF improvement between concurrent vs. sequential exercise therapy relative to usual care in women with primary breast cancer. The promising tolerability and CRF benefit of ≈32 weeks of continuous exercise therapy warrant further evaluation in larger trials.
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Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/tratamento farmacológico , Qualidade de Vida , Consumo de Oxigênio , Terapia por Exercício/métodos , Quimioterapia AdjuvanteRESUMO
BACKGROUND: Oral chemotherapy performance measures were first introduced into ASCO's Quality Oncology Practice Initiative (QOPI) in 2013. This study examined performance on these measures among QOPI-participating practices and evaluated whether it differed among practices based on meeting QOPI Certification Program standards. METHODS: A total of 192 QOPI-participating practices (certified, n=50 [26%]; not certified, n=142 [74%]) reported performance on oral chemotherapy measures in 2017 and 2018. Inclusion was limited to practices reporting on ≥3 charts for ≥1 oral chemotherapy measure. Performance was defined as the percentage of charts examined that adhered to the measure. Descriptive analyses were used to characterize performance within and across practices, and mixed-effects logistic regression models were conducted to compare performance based on certification status. RESULTS: Median performance across practices for the 9 oral chemotherapy measures examined ranged from 44% (education before the start of treatment addressing missed doses, toxicities, and clinical contact instructions [composite measure]) to 100% (documented dose, documented plan, and education about toxicities). Certified practices were more likely to provide education about clinic contact instructions than noncertified practices (odds ratio, 4.87; 95% CI, 1.00-24.0). Performance on all other measures was not significantly associated with certification status. CONCLUSIONS: There is wide variability in quality related to performance on oral chemotherapy measures across all QOPI-participating practices, and several areas were identified in which administration of oral chemotherapy could be improved. Our findings highlight the need for the development and implementation of appropriate standards that apply to oral chemotherapy and address the complexities that set it apart from parenteral treatment.
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Certificação , Oncologia , Administração Oral , HumanosRESUMO
BACKGROUND: Job loss after a cancer diagnosis can lead to long-term financial toxicity and its attendant adverse clinical consequences, including decreased treatment adherence. Among women undergoing (neo)adjuvant chemotherapy for breast cancer, access to work accommodations (e.g., sick leave) is associated with higher job retention after treatment completion. However, low-income and/or minority women are less likely to have access to work accommodations and, therefore, are at higher risk of job loss. Given the time and transportation barriers that low-income working patients commonly face, it is crucial to develop an intervention that is convenient and easy to use. METHODS: We designed an intervention to promote job retention during and after (neo)adjuvant chemotherapy for breast cancer by improving access to relevant accommodations. Talking to Employers And Medical staff about Work (TEAMWork) is an English/Spanish mobile application (app) that provides (1) suggestions for work accommodations tailored to specific job demands, (2) coaching/strategies for negotiating with an employer, (3) advice for symptom self-management, and (4) tools to improve communication with the medical oncology team. This study is a randomized controlled trial to evaluate the app as a job-retention tool compared to a control condition that provides the app content in an informational paper booklet. The primary outcome of the study is work status after treatment completion. Secondary outcomes include work status 1 and 2 years later, participant self-efficacy to ask an employer for accommodations, receipt of workplace accommodations during and following adjuvant therapy, patient self-efficacy to communicate with the oncology provider, self-reported symptom burden during and following adjuvant therapy, and cancer treatment adherence. DISCUSSION: This study will assess the use of mobile technology to improve vulnerable breast cancer patients' ability to communicate with their employers and oncology providers, work during treatment and retain their jobs in the long term, thereby diminishing the potential consequences of job loss, including decreased treatment adherence, debt, and bankruptcy. TRIAL REGISTRATION: ClincalTrials.gov NCT03572374 . Registered on 08 June 2018.
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Neoplasias da Mama , Aplicativos Móveis , Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante , Emprego , Feminino , Humanos , FolhetosRESUMO
Cancer survivors are frequently unprepared to manage the out-of-pocket (OOP) costs associated with undergoing cancer treatment and the potential for employment disruption. This commentary outlines a set of research recommendations stemming from the National Cancer Institute's Future of Health Economics Research Conference to better understand and reduce patient economic burden as part of cancer care delivery. Currently, there are a lack of detailed metrics and measures of survivors' OOP costs and employment disruption, and data on these costs are rarely available at the point of care to guide patient-centered treatment and survivorship care planning. Future research should improve the collection of data about survivors' OOP costs for medical care, other cancer-related expenses, and experiences of employment disruption. Methods such as microcosting and the prospective collection of patient-reported outcomes in cancer care are needed to understand the true sum of cancer-related costs taken on by survivors and caregivers. Better metrics and measures of survivors' costs must be coupled with interventions to incorporate that information into cancer care delivery and inform meaningful communication about OOP costs and employment disruption that is tailored to different clinical situations. Informing survivors about the anticipated costs of their cancer care supports informed decision making and proactive planning to mitigate financial hardship. Additionally, system-level infrastructure should be developed and tested to facilitate screening to identify survivors at risk for financial hardship, improve communication about OOP costs and employment disruption between survivors and their health-care providers, and support the delivery of appropriate financial navigation services.
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Sobreviventes de Câncer , Neoplasias , Emprego , Estresse Financeiro , Humanos , Neoplasias/diagnóstico , Neoplasias/terapia , Estudos ProspectivosRESUMO
Importance: Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene. Objective: To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes. Design, Setting, and Participants: Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021. Interventions: In the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care. Main Outcomes and Measures: The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available. Results: Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006). Conclusions and Relevance: In this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival. Trial Registration: ClinicalTrials.gov Identifier: NCT03249090.
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Monitorização Ambulatorial , Metástase Neoplásica , Medidas de Resultados Relatados pelo Paciente , Adulto , Eletrônica , Feminino , Indicadores Básicos de Saúde , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Monitorização Ambulatorial/instrumentação , Monitorização Ambulatorial/métodos , Metástase Neoplásica/diagnóstico , Metástase Neoplásica/terapia , Neoplasias/diagnóstico , Neoplasias/terapia , Segunda Neoplasia Primária/diagnóstico , Segunda Neoplasia Primária/terapia , Qualidade de Vida , Inquéritos e Questionários , TelemedicinaRESUMO
PURPOSE: Food insecurity is prevalent among low-income immigrant and minority patients with cancer. To our knowledge, this randomized controlled trial is the first to prospectively examine the impact on cancer outcomes of food insecurity interventions, with the goal of informing evidence-based interventions to address food insecurity in patients with cancer. METHODS: A three-arm randomized controlled trial was conducted among food-insecure (18-item US Department of Agriculture Household Food Security Survey Module score ≥ 3) patients with cancer (N = 117) at four New York City safety net cancer clinics. Arms included a hospital cancer clinic-based food pantry (arm 1), food voucher plus pantry (arm 2), and home grocery delivery plus pantry (arm 3). Treatment completion (primary outcome) and full appointment attendance were assessed at 6 months. Food security status, depression symptoms (Patient Health Questionnaire-9), and quality-of-life scores (Functional Assessment of Cancer Therapy-General) were assessed at baseline and at 6 months. RESULTS: Voucher plus pantry had the highest treatment completion rate (94.6%), followed by grocery delivery plus pantry (82.5%) and pantry (77.5%; P = .046). Food security scores improved significantly in all arms, and Patient Health Questionnaire-9 and Functional Assessment of Cancer Therapy-General scores improved significantly in the pantry and delivery plus pantry arms. CONCLUSION: Our findings in this preliminary study suggest that voucher plus pantry was the most effective intervention at improving treatment completion, and it met our a priori criterion for a promising intervention (≥ 90%). All interventions demonstrated the potential to improve food security among medically underserved, food-insecure patients with cancer at risk of impaired nutrition status, reduced quality of life, and poorer survival. All patients with cancer should be screened for food insecurity, with evidence-based food insecurity interventions made available.
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Assistência Alimentar , Neoplasias , Humanos , Abastecimento de Alimentos , Qualidade de Vida , Insegurança Alimentar , Neoplasias/terapiaRESUMO
BACKGROUND: The coronavirus pandemic has highlighted the health and financial vulnerabilities of essential workers, especially among women. OBJECTIVE: The purpose of this study is to understand the workplace environment of essential workers. METHODS: We used data from a prospective cohort study of disparities in employment outcomes among women undergoing breast cancer treatment between 2010-2018 in New York City. We characterized participants as essential or non-essential based on self-reported occupation/industry and New York State executive orders issued during the pandemic. We compared job benefits and perceptions of workplace environment between groups. RESULTS: There were 563 participants: 341 essential and 222 non-essential workers. Essential workers less frequently reported access to disability pay through work [n(%): 148 (58) versus 130 (73), pâ<â0.01]. Essential workers in unions had greater availability of sick leave and disability pay than non-unionized essential workers (86% versus 53%, pâ<â0.01, and 76% versus 46%, pâ<â0.01, respectively). Health insurance differed by essential worker status (pâ<â0.01): essential workers more frequently had public insurance (29% versus 18%). Surprisingly, in multivariable analyses controlling for age, race/ethnicity, income, education, chemotherapy receipt, and comfort with English, essential workers were less likely to say their employer had treated them unfairly (pâ<â0.01). However, minorities were less likely to say their employer was accommodating (pâ=â0.03) and more likely to say their employer had treated them unfairly (pâ<â0.01) than Non-Latina Whites. CONCLUSIONS: We identified vulnerabilities in workplace protections, particularly among essential workers not in unions. Minority women more often had negative perceptions of their work environment, possibly reflecting employer bias.
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Neoplasias da Mama , COVID-19 , Neoplasias da Mama/epidemiologia , COVID-19/epidemiologia , Feminino , Humanos , Masculino , Pandemias , Estudos Prospectivos , SARS-CoV-2 , Local de TrabalhoRESUMO
Many cancer patients experience a reduction in work status during cancer treatment. Authors analyzed cross-sectional survey data from U.S. cancer patients and survivors to examine the relationship between reduced work status and cost-related nonadherence, defined as skipping or forgoing medical treatments or medications due to cost. Of 381 respondents who were working at the time of diagnosis, 143 reported a reduction in work status during treatment. Age, racial identity, level of education, and treatment type were associated with reductions in work status. Respondents who reduced work status had higher odds of engaging in cost-related nonadherence than those with stable employment. Authors conclude that reduced work status is associated with nonadherence that can undermine treatment benefit and lead to disease progression. This association is troubling given that African American respondents were more likely to report reduced work status during treatment, potentially exacerbating existing cancer health disparities. To reduce treatment nonadherence, social workers should assess for potential employment problems and be prepared to intervene through counseling, community resource referrals, and direct financial assistance. Social workers should be aware of how structural racism is reproduced through inequitable labor policies and practices that have direct implications for health and access to care.
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Neoplasias , Sobreviventes , Negro ou Afro-Americano , Estudos Transversais , Emprego , Humanos , Adesão à Medicação , Neoplasias/terapiaRESUMO
BACKGROUND: In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. METHODS: This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach's alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran-Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. RESULTS: A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach's alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. CONCLUSION: The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.
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Neoplasias , Medidas de Resultados Relatados pelo Paciente , Adulto , Ansiedade , Fadiga , Humanos , Neoplasias/psicologia , Neoplasias/terapia , Dor , Avaliação de Resultados da Assistência ao PacienteAssuntos
Sobreviventes de Câncer , Neoplasias , Emprego , Estresse Financeiro , Gastos em Saúde , Humanos , Neoplasias/epidemiologia , Neoplasias/terapia , DorRESUMO
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.
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Estresse Financeiro , Neoplasias dos Genitais Femininos , Adulto , Feminino , Neoplasias dos Genitais Femininos/terapia , Gastos em Saúde , Humanos , Aceitação pelo Paciente de Cuidados de Saúde , Fatores de RiscoRESUMO
This report describes the rationale, purpose and design of A011801 (CompassHER2 RD), an ongoing prospective, multicenter, Phase III randomized trial. Eligible patients in the United States (US) and Canada with high-risk (defined as ER-negative and/or node-positive) HER2-positive (HER2+) residual disease (RD) after a predefined course of neoadjuvant chemotherapy and HER2-directed treatment are randomized 1:1 to adjuvant T-DM1 and placebo, versus T-DM1 and tucatinib. Patients have also received adjuvant radiotherapy and/or endocrine therapy, if indicated per standard of care guidelines. The primary objective of the trial is to determine if the invasive disease-free survival (iDFS) with T-DM1 plus tucatinib is superior to iDFS with T-DM1 plus placebo; other outcomes of interest include overall survival (OS), breast cancer-free survival (BCFS), distant recurrence-free survival (DRFS), brain metastases-free survival (BMFS) and disease-free survival (DFS). Correlative biomarker, quality of life (QoL) and pharmacokinetic (PK) end points are also evaluated.
Lay abstract In this research study (A011801; CompassHER2 RD), patients with early stage HER2-positive breast cancer who already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery are mainly enrolled. If cancer is still present in the breast and/or lymph nodes at the time of surgery, there is a higher risk of a recurrence in the future, and enrollment on A011801 is an option. Usually, if there is tumor remaining after chemotherapy and anti-HER2 targeted therapies, the main treatment is the use of an FDA-approved intravenous drug called T-DM1. Additional treatment may also include radiotherapy and/or medications to block the activity of estrogen. The usual treatment approach reduces the likelihood of breast cancer recurring in the future. This study has been performed to answer the following question: Is the combination of T-DM1 and a newer drug tucatinib better than usual treatment with T-DM1 alone at preventing cancer from returning? Study participants will receive treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless their breast cancer returns or the side effects become too severe. Research bloods are taken on study along with standard blood work, and we also request a stored tumor sample from the original biopsy and from the breast cancer surgery for research purposes. Optional Quality of Life Questionnaires are also included in the trial. After the study, participants finish T-DM1 and placebo, or T-DM1 and tucatinib, and their doctor will continue to follow their condition with clinic visits every 6 months for 10 years and watch for side effects and for signs of breast cancer recurring. Clinical Trial Registration: NCT04457596 (ClinicalTrials.gov).
Assuntos
Ado-Trastuzumab Emtansina/administração & dosagem , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias Encefálicas/epidemiologia , Neoplasias da Mama/terapia , Recidiva Local de Neoplasia/epidemiologia , Oxazóis/administração & dosagem , Piridinas/administração & dosagem , Quinazolinas/administração & dosagem , Ado-Trastuzumab Emtansina/efeitos adversos , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias Encefálicas/prevenção & controle , Neoplasias Encefálicas/secundário , Mama/patologia , Mama/cirurgia , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Quimiorradioterapia Adjuvante/efeitos adversos , Quimiorradioterapia Adjuvante/métodos , Quimioterapia Adjuvante/efeitos adversos , Quimioterapia Adjuvante/métodos , Ensaios Clínicos Fase III como Assunto , Intervalo Livre de Doença , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Mastectomia , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Terapia Neoadjuvante/métodos , Recidiva Local de Neoplasia/prevenção & controle , Neoplasia Residual , Oxazóis/efeitos adversos , Placebos/administração & dosagem , Placebos/efeitos adversos , Estudos Prospectivos , Piridinas/efeitos adversos , Quinazolinas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Receptor ErbB-2/análise , Receptor ErbB-2/metabolismoRESUMO
Background: More than one-half of breast cancer cases are diagnosed among women aged younger than 62 years, which may result in employment challenges. This study examined whether cancer-related employment disruption was associated with increased financial hardship in a national US study of women with breast cancer. Methods: Women with breast cancer who were enrolled in the Sister or Two Sister Studies completed a survivorship survey in 2012. Employment disruption was defined as stopping work completely or working fewer hours after diagnosis. Financial hardship was defined as: 1) experiencing financial problems paying for cancer care, 2) borrowing money or incurring debt, or 3) filing for bankruptcy because of cancer. Prevalence ratios and 95% confidence intervals for the association between employment disruption and financial hardship were estimated using multivariable Poisson regression with robust variance. Results: We analyzed data from women employed at diagnosis (n = 1628). Women were a median age of 48 years at diagnosis and 5.6 years from diagnosis at survey completion. Overall, 27.3% of women reported employment disruption (15.4% stopped working; 11.9% reduced hours), and 21.0% experienced financial hardship (16.0% had difficulty paying for care; 12.6% borrowed money or incurred debt; 1.8% filed for bankruptcy). In adjusted analysis, employment disruption was associated with nearly twice the prevalence of financial hardship (prevalence ratio = 1.93, 95% confidence interval = 1.58 to 2.35). Conclusions: Women experiencing employment disruptions after breast cancer may be more vulnerable to financial hardship. Findings highlight the need to target risk factors for employment disruption, facilitate return to work or ongoing employment, and mitigate financial consequences after cancer.
Assuntos
Neoplasias da Mama/economia , Emprego , Estresse Financeiro/economia , Adulto , Idoso , Falência da Empresa/economia , Falência da Empresa/estatística & dados numéricos , Neoplasias da Mama/complicações , Escolaridade , Emprego/estatística & dados numéricos , Feminino , Estresse Financeiro/epidemiologia , Estresse Financeiro/etiologia , Gastos em Saúde/estatística & dados numéricos , Humanos , Renda , Pessoa de Meia-Idade , Distribuição de Poisson , Prevalência , Inquéritos e Questionários , Sobrevivência , Desemprego/estatística & dados numéricos , Estados Unidos/epidemiologiaRESUMO
PURPOSE: To assess the prevalence of socioeconomic needs and associations between housing characteristics and food insecurity among low-income cancer patients, among whom housing and food insecurity are particularly prevalent. METHODS: Low-income cancer patients in active treatment (N = 1618) were enrolled in a comprehensive patient navigation program. Food insecurity was assessed using the 18-item US Department of Agriculture US Household Food Security Survey Module. Participants self-reported their need for assistance with housing issues/type of assistance needed, perception of overcrowding, satisfaction with living situation, and household density via a cross-sectional survey. Descriptive analyses, cross-tabulations and tests of proportions, and binary logistic regression were used in data analyses. RESULTS: Seventy percent of patients were food insecure. Housing characteristics associated with food insecurity were homelessness or living in sheltered/supportive housing (83.3% food insecure), renting (71.9%), and homeownership (58.1%; p < .001); living situation satisfaction (not satisfied, 79.4%; somewhat satisfied, 25.6%; very satisfied, 66%; p < .001); need of housing assistance (79.2%; p < .001), and feeling crowded in their living unit (77.6%; p < .05). Associations of living unit type with food insecurity were significant in the binary logistic regression model (renters 1.68 OR, homeless/sheltered housing 2.80 OR vs homeowners). CONCLUSION: The vulnerability to food insecurity of patients in this low-income sample was underlined by the high rates found, and clear associations with housing characteristics of homelessness, housing assistance needs, and feeling overcrowded were identified. These results could help shape priorities around screening patients for nutrition and housing needs and developing interventions to address them.