Increasing physical activity among older adults with gynecologic cancers: a qualitative study.

PURPOSE: The purpose of this study was to gain an understanding of older gynecologic cancer patients' preferences and opinions related to physical activity during chemotherapy, including interventions to promote physical activity. METHODS: Gynecologic cancer patients 60 years or older receiving chemotherapy at a single institution within the last 12 months completed questionnaires and a semi-structured interview asking about their preferences for physical activity interventions aimed at promoting physical activity while receiving treatment. RESULTS: Among the 30 gynecologic cancer patients surveyed and interviewed, a majority agreed with the potential usefulness of a physical activity intervention during chemotherapy (67%) and most reported they would be willing to use an activity tracker during chemotherapy (73%). They expressed a preference for an aerobic activity intervention such as walking, indicated a desire for education from their clinical team on the effects physical activity can have on treatment symptoms, and stated a need for an intervention that could be accessed from anywhere and anytime. Additionally, they emphasized a need for an intervention that considered their treatment symptoms as these were a significant barrier to physical activity while on chemotherapy. CONCLUSION: In this study of older gynecologic cancer patients receiving chemotherapy, most were open to participating in a virtually accessible and symptom-tailored physical activity intervention to promote physical activity during chemotherapy.

Practical Assessment and Management of Vulnerabilities in Older Patients Receiving Systemic Cancer Therapy: ASCO Guideline Update.

PURPOSE: To update the ASCO guideline (2018) on the practical assessment and management of age-associated vulnerabilities in older patients undergoing systemic cancer therapy. METHODS: An Expert Panel conducted a systematic review to identify relevant randomized clinical trials (RCTs), systematic reviews, and meta-analyses from January 2016 to December 2022. RESULTS: A total of 26 publications met eligibility criteria and form the evidentiary basis for the update. RECOMMENDATIONS: The Expert Panel reiterates its overarching recommendation from the prior guideline that geriatric assessment (GA), including all essential domains, should be used to identify vulnerabilities or impairments that are not routinely captured in oncology assessments for all patients over 65 years old with cancer. Based on recently published RCTs demonstrating significantly improved clinical outcomes, all older adults with cancer (65+ years old) receiving systemic therapy with GA-identified deficits should have GA-guided management (GAM) included in their care plan. GAM includes using GA findings to inform cancer treatment decision-making as well as to address impairments through appropriate interventions, counseling, and/or referrals. A GA should include high priority aging-related domains known to be associated with outcomes in older adults with cancer: physical and cognitive function, emotional health, comorbid conditions, polypharmacy, nutrition, and social support. Clinical adaptation of the GA based on patient population, resources, and time is appropriate.The Panel recommends the Practical Geriatric Assessment as one option for this purpose (https://old-prod.asco.org/sites/new-www.asco.org/files/content-files/practice-patients/documents/2023-PGA-Final.pdf; https://youtu.be/jnaQIjOz2Dw; https://youtu.be/nZXtwaGh0Z0).Additional information is available at www.asco.org/supportive-care-guidelines.

Engaging disparities in prostate cancer: Piloting an interactive, virtual workshop to educate providers on shared decision-making for underserved populations.

OBJECTIVE: Shared decision-making (SDM) is an approach to patient-centered care that is strongly recommended when counseling patients for screening and treatment of prostate cancer. However, providers report lack of comfort with SDM and particularly in disparate populations. We report our experience designing and piloting an online workshop to educate practicing urologists on SDM in diverse populations. Our objective was to create a valued interactive SDM workshop to help urologists learn to lead SDM discussions with men form underserved populations. Therefore, we tested the hypothesis that urologists would agree or strongly agree that we met our learning objectives on postcourse survey. MATERIALS AND METHODS: With the support of the American Urologic Association, we developed a case-based workshop with interactive role-playing to demonstrate and teach integration of SDM into clinical care. Cases were centered around screening and treatment decisions for localized prostate cancer in diverse patients. Brief surveys were used to track success with learning objectives and urologists' satisfaction with the workshop. RESULTS: The session included 14 participants from 6 countries. A postworkshop survey indicated that 100% of respondents (8 of 8) "strongly agreed" that the activity met learning objectives, and 100% rated the session as "good" (1), "very good" (1), or "excellent" (6). Participants' knowledge also improved on shared decision-making concepts and the knowledge was maintained one month after the workshop. CONCLUSION: We successfully created and piloted an interactive online workshop to improve urologists' comfort using shared decision-making in caring for diverse patient populations. The course met its objectives and participant feedback for the course was positive. Sharing this process and framework for development of this intervention may inform future workshops that can be applied to medical students, residents, and providers.

Mistreatment and Wellness Among International Medical Graduates in US General Surgical Residency.

This study uses data from a cross-sectional national survey of medical residents in the US to assess whether mistreatment experiences and wellness differ between international medical graduates and US medical graduates.

Integrating Geriatric Assessment Measures into National Cancer Institute Clinical Trials.

To improve the care of older adults with cancer, the traditional approach to clinical trial design needs to be reconsidered. Older adults are underrepresented in clinical trials with limited or no information on geriatric-specific factors, such as cognition or comorbidities. To address this knowledge gap and increase relevance of therapeutic clinical trial results to the real-life population, integration of aspects relevant to older adults is needed in oncology clinical trials. Geriatric assessment (GA) is a multidimensional tool comprising validated measures assessing specific health domains that are more frequently affected in older adults, including aspects related to physical function, comorbidity, medication use (polypharmacy), cognitive and psychological status, social support, and nutritional status. There are several mechanisms for incorporating either the full GA or specific GA measures into oncology therapeutic clinical trials to contribute to the overarching goal of the trial. Mechanisms include utilizing GA measures to better characterize the trial population, define trial eligibility, allocate treatment receipt within the context of the trial, develop predictive models for treatment outcomes, guide supportive care strategies, personalize care delivery, and assess longitudinal changes in GA domains. The objective of this manuscript is to review how GA measures can contribute to the overall goal of a clinical trial, to provide a framework to guide the selection and integration of GA measures into clinical trial design, and ultimately enable accrual of older adults to clinical trials by facilitating the design of trials tailored to older adults treated in clinical practice.

Social Justice and Equity: Why Older Adults With Cancer Belong-A Life Course Perspective.

The population of older adults with cancer in the United States is rapidly increasing, which will have a substantial impact on the oncology and public health workforces across the cancer continuum, from prevention to end of life. Unfortunately, inequities in existing social structures that cause increased psychosocial stressors have led to disparities in the incidence of cancer and the morbidity and mortality of cancer for individuals from marginalized backgrounds. It is imperative that older adults, especially those from historically marginalized backgrounds, be adequately represented in all stages of cancer research to address health inequities. Continued efforts and progress toward achieving social justice and health equity require a deeper commitment to and better understanding of the impact of social determinants of health within the cancer domain. Undoubtedly, a more holistic and integrated view that extends beyond the biologic and genetic factors of health must be adopted for health entities to recognize the critical role of environmental, behavioral, and social determinants in cancer health disparities. Against this backdrop, this paper uses a life course approach to present a multifactorial framework for understanding and addressing cancer disparities in an effort to advance social justice and health equity for racially and ethnically diverse older adults.

NCCN Guidelines® Insights: Older Adult Oncology, Version 1.2021.

The NCCN Guidelines for Older Adult Oncology address specific issues related to the management of cancer in older adults, including screening and comprehensive geriatric assessment (CGA), assessing the risks and benefits of treatment, preventing or decreasing complications from therapy, and managing patients deemed to be at high risk for treatment-related toxicity. CGA is a multidisciplinary, in-depth evaluation that assesses the objective health of the older adult while evaluating multiple domains, which may affect cancer prognosis and treatment choices. These NCCN Guidelines Insights focus on recent updates to the NCCN Guidelines providing specific practical framework for the use of CGA when evaluating older adults with cancer.

Consequences to patients, clinicians, and manufacturers when very serious adverse drug reactions are identified (1997-2019): A qualitative analysis from the Southern Network on Adverse Reactions (SONAR).

BACKGROUND: Adverse drug/device reactions (ADRs) can result in severe patient harm. We define very serious ADRs as being associated with severe toxicity, as measured on the Common Toxicity Criteria Adverse Events (CTCAE)) scale, following use of drugs or devices with large sales, large financial settlements, and large numbers of injured persons. We report on impacts on patients, clinicians, and manufacturers following very serious ADR reporting. METHODS: We reviewed clinician identified very serious ADRs published between 1997 and 2019. Drugs and devices associated with reports of very serious ADRs were identified. Included drugs or devices had market removal discussed at Food and Drug Advisory (FDA) Advisory Committee meetings, were published by clinicians, had sales > $1 billion, were associated with CTCAE Grade 4 or 5 toxicity effects, and had either >$1 billion in settlements or >1,000 injured patients. Data sources included journals, Congressional transcripts, and news reports. We reviewed data on: 1) timing of ADR reports, Boxed warnings, and product withdrawals, and 2) patient, clinician, and manufacturer impacts. Binomial analysis was used to compare sales pre- and post-FDA Advisory Committee meetings. FINDINGS: Twenty very serious ADRs involved fifteen drugs and one device. Legal settlements totaled $38.4 billion for 753,900 injured persons. Eleven of 18 clinicians (61%) reported harms, including verbal threats from manufacturer (five) and loss of a faculty position (one). Annual sales decreased 94% from $29.1 billion pre-FDA meeting to $4.9 billion afterwards (p<0.0018). Manufacturers of four drugs paid $1.7 billion total in criminal fines for failing to inform the FDA and physicians about very serious ADRs. Following FDA approval, the median time to ADR reporting was 7.5 years (Interquartile range 3,13 years). Twelve drugs received Box warnings and one drug received a warning (median, 7.5 years following ADR reporting (IQR 5,11 years). Six drugs and 1 device were withdrawn from marketing (median, 5 years after ADR reporting (IQR 4,6 years)). INTERPRETATION: Because very serious ADRs impacts are so large, policy makers should consider developing independently funded pharmacovigilance centers of excellence to assist with clinician investigations. FUNDING: This work received support from the National Cancer Institute (1R01 CA102713 (CLB), https://www.nih.gov/about-nih/what-we-do/nih-almanac/national-cancer-institute-nci; and two Pilot Project grants from the American Cancer Society's Institutional Grant Award to the University of South Carolina (IRG-13-043-01) https://www.cancer.org/ (SH; BS).

Identifying Geriatric Oncology Competencies for Medical Oncology Trainees: A Modified Delphi Consensus Study.

BACKGROUND: Most oncology trainees are not taught about the needs of older patients, who make up the majority of patients with cancer. Training of health care providers is critical to improve the care of older adults with cancer. There is no consensus about which geriatric oncology (GO) competencies are important for medical oncology trainees. Our objective was to identify GO competencies medical oncology trainees should acquire during training. MATERIALS AND METHODS: A modified Delphi consensus of experts in oncology medical education and GO was conducted. Experts categorized at what training stage proposed competencies should be attained: internal medicine, oncology, or GO training. Consensus was obtained if two thirds of experts agreed on the training stage at which the competency should be attained. RESULTS: A total of 78 potential competencies were identified, of which 35 (44.9%) proposed competencies were felt to be appropriate to be acquired during oncology training. The majority of the identified competencies pertained to prescribing of systemic therapy (n = 12) and psychosocial and supportive care (n = 13). No competencies related to geriatric assessment were identified for acquisition during oncology training. CONCLUSION: Experts in oncology education and geriatric oncology agreed upon a set of GO competencies appropriate for oncology trainees. These results provide the foundation for developing a GO curriculum for medical oncology trainees and will hopefully lead to better care of older adults with cancer. IMPLICATIONS FOR PRACTICE: The aging population will drive the projected rise in cancer incidence. Although aging patients make up the majority of patients diagnosed with cancer, oncologists rarely receive training on how to care for them. Training of health care providers is critical to improving the care of older adults with cancer. The results of this study will help form the foundation of developing a geriatric oncology curriculum for medical oncology trainees.

Cancer Comorbidity: Implications for Drug Safety.

Cancer is primarily a disease of aging. This chapter discusses relevant aspect of the physiology of aging, medication use and toxicity, comorbidities, and specific challenges in treating older adults with cancer.

Pharmacovigilance of Alternative Medications in the Cancer Setting.

With the increase in utilization of alternative medications to manage cancer treatment-related side effects, pharmacovigilance of alternative drug therapies, specifically herbal supplements, has become of increasing importance in the oncologic setting. This chapter focuses on the pharmacovigilance of herbal supplements in the setting of cancer drug therapy and explores national and international drug policies that have been employed to mitigate adverse herbal supplement events (AHEs). This chapter examines common drug-herbal supplement interactions, discusses the mechanisms behind these interactions, and investigates several common pharmacovigilance reporting methods clinicians can use to report adverse events. This chapter will also describe policies and strategies that can be employed to monitor use of these alternative drug therapies, and examines global harmonization efforts to reduce AHEs in the cancer setting. The safety of herbal medicines has emerged as an international public health priority, and we explore how oncology providers may directly apply the knowledge garnered herein to help guide their clinical management of oncology patients utilizing alternative medications.

Biosimilars: Are They Really Safe?

An increasing availability of biosimilars is an important step in the process of delivering optimal care while improving access for patients with cancer. Evolving regulatory mechanisms deal with biosimilars with different approaches within major regulatory agencies. We discuss some of the specific properties of biosimilars that merit attention in terms of optimizing their safety, delivering on appropriate related cost savings, and ensuring that appropriate premiums on innovative research are available to ensure ongoing progress in anticancer therapy.

Anatomy of Risk Evaluation and Mitigation Strategies (REMS).

This Chapter provides an introduction and overview of the U.S. FDA REMS program and applicable regulatory aspects. Topics covered include the 2015 Draft Guidance, organization structure and functions, a discussion on pharmacovigilance and adverse event reports, and a discussion of the applicability of REMS in oncology.

Cancer Drug Toxicity: Moving from Patient to Survivor.

Millions of individuals worldwide are living with cancer and have remained disease-free for more than 5 years. These individuals are considered to be cancer survivors. The advent of new targeted therapies and personalized treatment modalities have contributed to this increased survivorship. Additionally, earlier diagnosis and detection of cancer, greater access to preventive screenings, and greater focus on cancer pharmaceutical safety have all been contributed to increasing longevity. Of note, all cancer types have benefited in the survivorship arena. The advent of expansive survivorship care planning mandated by national governmental agencies and the emergence of newer classes of drug therapies for cancer are expected to buttress and support cancer survivorship in the coming decades.

Moonshot to Cancer Cure: Recruiting Policy to Break Down Silos.

Funded by the 21st Century Cures Act, The Beau Biden Cancer Moonshot Initiative is broad, deep, integrative, and intended to expediently address cancer's most vexing problems. Launched in 2015, it is an effort to accelerate the pace of cancer research with a focus on breaking down silos through cross-pollination of research, recruitment of multidisciplinary clinical and basic science research teams, sharing of complex scientific databases, and the creation of public-private research partnerships. This audacious approach to cancer treatment is intended to alleviate the current burden of cancer within countries and across borders. At its core is the rapid development of safe drug therapies across different disciplines through the employment of genomics, targeted proteomics with predictive analytics, and other emerging drug therapies. It will use expansive patient registries and increase early access to clinical trials. The initiative is cocooned in forward-thinking drug policies that consider the specific needs of all oncology stakeholder groups both nationally and internationally.

Sepsis in Older Adults.

Sepsis disproportionally affects older adults with more than 60% of sepsis diagnoses attributed to adults aged 65 years and older. Identifying, diagnosing, and treating sepsis in older individuals remain a challenge for clinicians, and few studies focus specifically on older adults with multiple medical comorbidities. Principles guiding management of sepsis for older adults are generally the same as in younger adults; however, unique considerations particularly pertinent to the care older adults include antimicrobial selection and dosing, delirium management, and goals of care discussions. Other factors, such as medical comorbidities, cognitive impairment, and functional status, impact outcomes more than age alone.

NCCN Guidelines Insights: Older Adult Oncology, Version 2.2016.

Cancer is the leading cause of death in older adults aged 60 to 79 years. Older patients with good performance status are able to tolerate commonly used treatment modalities as well as younger patients, particularly when adequate supportive care is provided. For older patients who are able to tolerate curative treatment, options include surgery, radiation therapy (RT), chemotherapy, and targeted therapies. RT can be highly effective and well tolerated in carefully selected patients, and advanced age alone should not preclude the use of RT in older patients with cancer. Judicious application of advanced RT techniques that facilitate normal tissue sparing and reduce RT doses to organs at risk are important for all patients, and may help to assuage concerns about the risks of RT in older adults. These NCCN Guidelines Insights focus on the recent updates to the 2016 NCCN Guidelines for Older Adult Oncology specific to the use of RT in the management of older adults with cancer.

Survivorship care planning in a comprehensive cancer center using an implementation framework.

Cancer survivorship care plans (SCPs) have been recommended to improve clinical care and patient outcomes. Research is needed to establish their efficacy and identify best practices. Starting in 2015, centers accredited by the American College of Surgeons Commission on Cancer must deliver SCPs to patients completing primary cancer treatment with curative intent. We describe how we established routine SCP delivery at the Robert H Lurie Comprehensive Cancer Center in Chicago, Illinois, using the Quality Implementation Framework. We evaluated local practices, gathered clinician and patient stakeholder input, developed customized SCP templates within the electronic health record (EHR), and implemented 2 complementary delivery models. Clinician interviews (n = 41) and survey responses (n = 12), along with input from patients (n = 68) and a patient advisory board (n = 15), indicated support for SCPs and survivorship services. To promote feasible implementation and leverage existing workflows, we harmonized 2 SCP delivery models: integrated care within clinics where patients received treatment, and referral to a centralized survivorship clinic. We are implementing SCP delivery with prominent disease sites and will extend services to survivors of other cancers in the future. We developed four electronic disease-specific SCP templates for breast, colorectal, lung, and prostate cancers and a fifth, generic template that can be used for other malignancies. The templates reduced free-text clinician entry by auto-populating 20% of the fields from existing EHR data, and using drop-down menus for another 65%. Mean SCP completion time is 12 minutes (range, 10-15; n = 64). We designed our framework to facilitate ongoing evaluation of implementation and quality improvement. Funding/sponsorship Robert H Lurie Comprehensive Cancer Center, the Coleman Foundation, and the Lynn Sage Cancer Research Foundation.