Learning Objectives
Describe the experiences of insured cancer patients requesting copayment assistance in order to better understand the challenges of underinsurance.
Describe the impact of costs on ...the well being of insured cancer patients.
Evaluate the impact of costs on the treatment received by insured cancer patients.
Purpose.
Cancer patients carry rising burdens of health care‐related out‐of‐pocket expenses, and a growing number of patients are considered “underinsured.” Our objective was to describe experiences of insured cancer patients requesting copayment assistance and to describe the impact of health care expenses on well‐being and treatment.
Methods.
We conducted baseline and follow‐up surveys regarding the impact of health care costs on well‐being and treatment among cancer patients who contacted a national copayment assistance foundation along with a comparison sample of patients treated at an academic medical center.
Results.
Among 254 participants, 75% applied for drug copayment assistance. Forty‐two percent of participants reported a significant or catastrophic subjective financial burden; 68% cut back on leisure activities, 46% reduced spending on food and clothing, and 46% used savings to defray out‐of‐pocket expenses. To save money, 20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether. Copayment assistance applicants were more likely than nonapplicants to employ at least one of these strategies to defray costs (98% vs. 78%). In an adjusted analysis, younger age, larger household size, applying for copayment assistance, and communicating with physicians about costs were associated with greater subjective financial burden.
Conclusion.
Insured patients undergoing cancer treatment and seeking copayment assistance experience considerable subjective financial burden, and they may alter their care to defray out‐of‐pocket expenses. Health insurance does not eliminate financial distress or health disparities among cancer patients. Future research should investigate coverage thresholds that minimize adverse financial outcomes and identify cancer patients at greatest risk for financial toxicity.
The experiences of insured cancer patients requesting copayment assistance and the impact of health care expenses on well‐being and treatment are examined. Insured patients undergoing cancer treatment and seeking copayment assistance were found to experience considerable subjective financial burden and were found to alter care to defray out‐of‐pocket expenses.
An American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) offers timely clinical direction to ASCO's membership following publication or presentation of potentially ...practice-changing data from major studies. This PCO addresses the integration of palliative care services into standard oncology practice at the time a person is diagnosed with metastatic or advanced cancer.
Palliative care is frequently misconstrued as synonymous with end-of-life care. Palliative care is focused on the relief of suffering, in all of its dimensions, throughout the course of a patient's illness. Although the use of hospice and other palliative care services at the end of life has increased, many patients are enrolled in hospice less than 3 weeks before their death, which limits the benefit they may gain from these services. By potentially improving quality of life (QOL), cost of care, and even survival in patients with metastatic cancer, palliative care has increasing relevance for the care of patients with cancer. Until recently, data from randomized controlled trials (RCTs) demonstrating the benefits of palliative care in patients with metastatic cancer who are also receiving standard oncology care have not been available.
Seven published RCTs form the basis of this PCO.
Based on strong evidence from a phase III RCT, patients with metastatic non-small-cell lung cancer should be offered concurrent palliative care and standard oncologic care at initial diagnosis. While a survival benefit from early involvement of palliative care has not yet been demonstrated in other oncology settings, substantial evidence demonstrates that palliative care-when combined with standard cancer care or as the main focus of care-leads to better patient and caregiver outcomes. These include improvement in symptoms, QOL, and patient satisfaction, with reduced caregiver burden. Earlier involvement of palliative care also leads to more appropriate referral to and use of hospice, and reduced use of futile intensive care. While evidence clarifying optimal delivery of palliative care to improve patient outcomes is evolving, no trials to date have demonstrated harm to patients and caregivers, or excessive costs, from early involvement of palliative care. Therefore, it is the Panel's expert consensus that combined standard oncology care and palliative care should be considered early in the course of illness for any patient with metastatic cancer and/or high symptom burden. Strategies to optimize concurrent palliative care and standard oncology care, with evaluation of its impact on important patient and caregiver outcomes (eg, QOL, survival, health care services utilization, and costs) and on society, should be an area of intense research.
ASCO's provisional clinical opinions (PCOs) reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision making and identify questions and settings for further research. Because of the rapid flow of scientific information in oncology, new evidence may have emerged since the time a PCO was submitted for publication. PCOs are not continually updated and may not reflect the most recent evidence. PCOs cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any PCO is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances. ASCO PCOs describe the use of procedures and therapies in clinical trials and cannot be assumed to apply to the use of these interventions in the context of clinical practice. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's PCOs, or for any errors or omissions.
Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical ...Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.
Patients with advanced incurable cancer face complex physical, psychological, social, and spiritual consequences of disease and its treatment. Care for these patients should include an individualized ...assessment of the patient's needs, goals, and preferences throughout the course of illness. Consideration of disease-directed therapy, symptom management, and attention to quality of life are important aspects of quality cancer care. However, emerging evidence suggests that, too often, realistic conversations about prognosis, the potential benefits and limitations of disease-directed therapy, and the potential role of palliative care, either in conjunction with or as an alternative to disease-directed therapy, occur late in the course of illness or not at all. This article addresses the American Society of Clinical Oncology's (ASCO's) vision for improved communication with and decision making for patients with advanced cancer. This statement advocates an individualized approach to discussing and providing disease-directed and supportive care options for patients with advanced cancer throughout the continuum of care. Building on ASCO's prior statements on end-of-life care (1998) and palliative care (2009), this article reviews the evidence for improved patient care in advanced cancer when patients' individual goals and preferences for care are discussed. It outlines the goals for individualized care, barriers that currently limit realization of this vision, and possible strategies to overcome these barriers that can improve care consistent with the goals of our patients and evidence-based medical practice.
In contrast to clinical biopsies, where tissue is collected to inform patient care, research biopsies are performed for scientific purposes to potentially enhance understanding of the biologic bases ...of cancer and drug action, thereby improving diagnosis and treatment, but they may offer no direct benefit to participants and have known risks. The widespread use of research biopsies that do not have the potential to directly benefit participants has come under scrutiny, with critics raising ethical concerns related to the adequacy of participant protections, informed consent, and participant understanding of the risks and benefits, as well as the scientific impact of research biopsies on drug development and treatment. This manuscript presents the American Society of Clinical Oncology's (ASCO's) ethical framework for incorporation of research biopsies in trials. The framework provides guidance on the circumstances to include optional and mandatory biopsies, as well as provides recommendations to stakeholders on necessary steps for improving the conduct of research biopsies overall.
IMPORTANCE: Young women with breast cancer are increasingly choosing bilateral mastectomy (BM), yet little is known about short-term and long-term physical and psychosocial well-being following ...surgery in this population. OBJECTIVE: To evaluate the differential associations of surgery with quality of life (QOL) and psychosocial outcomes from 1 to 5 years following diagnosis. DESIGN, SETTING, AND PARTICIPANTS: Cohort study SETTING: Multicenter, including academic and community hospitals in North America PARTICIPANTS: Women age ≤40 when diagnosed with Stage 0-3 with unilateral breast cancer between 2006 and 2016 who had surgery and completed QOL and psychosocial assessments. EXPOSURES (FOR OBSERVATIONAL STUDIES): Primary breast surgery including breast-conserving surgery (BCS), unilateral mastectomy (UM), and BM. MAIN OUTCOMES AND MEASURES: Physical functioning, body image, sexual health, anxiety and depressive symptoms were assessed in follow-up. RESULTS: Of 826 women, mean age at diagnosis was 36.1 years; most women were White non-Hispanic (86.7%). Regarding surgery, 45% had BM, 31% BCS, and 24% UM. Of women who had BM/UM, 84% had reconstruction. While physical functioning, sexuality, and body image improved over time, sexuality and body image were consistently worse (higher adjusted mean scores) among women who had BM vs BCS (body image: year 1, 1.32 vs 0.64; P < .001; year 5, 1.19 vs 0.48; P < .001; sexuality: year 1, 1.66 vs 1.20, P < .001; year 5, 1.43 vs 0.96; P < .001) or UM (body image: year 1, 1.32 vs 1.15; P = .06; year 5, 1.19 vs 0.96; P = .02; sexuality: year 1, 1.66 vs 1.41; P = .02; year 5, 1.43 vs 1.09; P = .002). Anxiety improved across groups, but adjusted mean scores remained higher among women who had BM vs BCS/UM at 1 year (BM, 7.75 vs BCS, 6.94; P = .005; BM, 7.75 vs UM, 6.58; P = .005), 2 years (BM, 7.47 vs BCS, 6.18; P < .001; BM, 7.47 vs UM, 6.07; P < .001) and 5 years (BM, 6.67 vs BCS, 5.91; P = .05; BM, 6.67 vs UM, 5.79; P = .05). There were minimal between-group differences in depression levels in follow-up. CONCLUSIONS AND RELEVANCE: While QOL improves over time, young breast cancer survivors who undergo more extensive surgery have worse body image, sexual health, and anxiety compared with women undergoing less extensive surgery. Ensuring young women are aware of the short-term and long-term effects of surgery and receive support when making surgical decisions is warranted.
Antibiotic exposure before immune checkpoint inhibitor (ICI) treatment can negatively affect outcomes through alteration in the gut microbiome, but large-scale evaluations are lacking. We performed a ...population-level retrospective cohort study to evaluate the impact of antibiotic exposure before starting ICI on overall survival (OS).
Patients with cancer, age 65 years or older, who initiated treatment with ICIs between June 2012 and October 2018 in Ontario, Canada, were identified using systemic therapy administration data. The cohort was deterministically linked to other health care databases to obtain covariates and antibiotic prescription claim data at both 1 year and 60 days before ICI therapy. Multivariable Cox models evaluated the association between exposure and OS.
Among the 2,737 patients with cancer who received ICIs, 59% and 19% of patients received antibiotics 1 year and 60 days before ICI therapy, respectively. Median OS was 306 days. Any antibiotic exposure within 1 year before ICI was associated with worse OS (adjusted hazard ratio aHR, 1.12; 95% CI, 1.12 to 1.23;
= .03). In antibiotic class analysis, exposure to fluoroquinolones within 1 year (aHR, 1.26; 95% CI, 1.13 to 1.40;
< .001) or 60 days before ICI (aHR, 1.20; 95% CI, 0.99 to 1.45;
= .06) was associated with worse OS, with a dose effect seen on the basis of total weeks of exposure over 1 year (aHR, 1.07 per week; 95% CI, 1.03 to 1.11;
< .001) and 60 days (aHR, 1.12 per week; 95% CI, 1.03 to 1.23;
= .01).
In this population-level study, exposure to antibiotics and specifically fluoroquinolones before ICI therapy was observed to be associated with worse OS among older adults with cancer. Interventions aimed at altering the gut microbiome to boost immunogenicity may help improve outcomes for patients receiving ICIs with prior antibiotic exposure.
PDF
