Access to cancer clinical trials for racialised older adults: an equity-focused rapid scoping review protocol.

BACKGROUND: The intersection of race and older age compounds existing health disparities experienced by historically marginalised communities. Therefore, racialised older adults with cancer are more disadvantaged in their access to cancer clinical trials compared with age-matched counterparts. To determine what has already been published in this area, the rapid scoping review question are: what are the barriers, facilitators and potential solutions for enhancing access to cancer clinical trials among racialised older adults? METHODS: We will use a rapid scoping review methodology in which we follow the six-step framework of Arksey and O'Malley, including a systematic search of the literature with abstract and full-text screening to be conducted by two independent reviewers, data abstraction by one reviewer and verification by a second reviewer using an Excel data abstraction sheet. Articles focusing on persons aged 18 and over who identify as a racialised person with cancer, that describe therapies/therapeutic interventions/prevention/outcomes related to barriers, facilitators and solutions to enhancing access to and equity in cancer clinical trials will be eligible for inclusion in this rapid scoping review. ETHICS AND DISSEMINATION: All data will be extracted from published literature. Hence, ethical approval and patient informed consent are not required. The findings of the scoping review will be submitted for publication in a peer-reviewed journal and presentation at international conferences.

Predictors and effects of toxicity experienced by older adults with cancer receiving systemic therapy in a randomized clinical trial of geriatric assessment.

INTRODUCTION: Older adults represent a large segment of the oncology population, however, they remain underrepresented in clinical research. Treatment of older adults is often extrapolated using data from younger and fitter patients, which may not be appropriate. Furthermore the implications of toxicity from treatment can be greater for this population. Predicting toxicity from treatment and its effect on quality of life and functional status for older adults therefore is important. MATERIALS AND METHODS: We analyzed data from a clinical trial of geriatric assessment and management for Canadian elders with cancer (5C study). We assessed whether the baseline Cancer and Aging Research Group (CARG) toxicity score, G8 score, and Eastern Cooperative Oncology Group (ECOG) performance predicted grade 3-5 toxicity using logistic regression and pattern mixture models. We also assessed the impact of toxicity on quality of life and functional decline. Patients were followed for six months. RESULTS: Three hundred sixteen patients were included. Mean age was 76 years old and 40% of patients were female. One hundred nineteen patients (38%) experienced at least one grade 3-5 toxicity. Neither the CARG toxicity score, G8, or ECOG were predictive of grade 3-5 toxicity. Patients who experienced grade 3-5 toxicity were more likely to have functional impairments over time (odds ratio 3.71, p = 0.03). However, they maintained their quality of life. DISCUSSION: In this secondary analysis of a randomized controlled trial of geriatric assessment and management we did not find any predictors of grade 3-5 toxicity. Patients who did experience toxicity were more likely to report functional decline over time. Older adults who do experience treatment related toxicity may benefit from increased supports. CLINICAL TRIAL INFORMATION: NCT0315467.

Implementing geriatric assessment and management for older Canadians with cancer: Adherence to and satisfaction with the intervention, results of the 5C study.

INTRODUCTION: Geriatric assessment and management (GAM) is recommended by professional organizations and recently several randomized controlled trials (RCTs) demonstrated benefits in multiple health outcomes. GAM typically leads to one or more recommendations for the older adult on how to optimize their health. However, little is known about how well recommendations are adhered to. Understanding these issues is vital to designing GAM trials and clinical programs. Therefore, the aim of this study was to examine the number of GAM recommendations made and adherence to and satisfaction with the intervention in a multicentre RCT of GAM for older adults with cancer. MATERIALS AND METHODS: The 5C study was a two-group parallel RCT conducted in eight hospitals across Canada. Each centre kept a detailed recruitment and retention log. The intervention teams documented adherence to their recommendations. Medical records were also reviewed to assess which recommendations were adhered to. Twenty-three semi-structured interviews were conducted with 12 members of the intervention teams and 11 oncology team members to assess implementation of the study and the intervention. RESULTS: Of the 350 participants who were enrolled, 173 were randomized to the intervention arm. Median number of recommendations was seven. Mean adherence to recommendations based on the GAM was 69%, but it varied by type of recommendation, ranging from 98% for laboratory tests to 28% for psychosocial/psychiatry oncology referrals. There was no difference in the number of recommendations or non-adherence to recommendations by sex, level of frailty, or functional status. Oncologists and intervention team members were satisfied with the study implementation and intervention delivery. DISCUSSION: Adherence to recommendations was variable. Adherence to laboratory investigations and further imaging were generally high but much lower for recommendations regarding psychosocial support. Further collaborative work with older adults with cancer is needed to understand how to optimize the intervention to be consistent with patient goals, priorities, and values to ensure maximal impact on health outcomes.

Impact of Geriatric Assessment and Management on Quality of Life, Unplanned Hospitalizations, Toxicity, and Survival for Older Adults With Cancer: The Randomized 5C Trial.

PURPOSE: American Society of Clinical Oncology recommends that older adults with cancer being considered for chemotherapy receive geriatric assessment (GA) and management (GAM), but few randomized controlled trials have examined its impact on quality of life (QOL). PATIENTS AND METHODS: The 5C study was a two-group parallel 1:1 single-blind multicenter randomized controlled trial of GAM for 6 months versus usual oncologic care. Eligible patients were age 70+ years, diagnosed with a solid tumor, lymphoma, or myeloma, referred for first-/second-line chemotherapy or immunotherapy or targeted therapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary outcome QOL was measured with the global health scale of the European Organisation for the Research and Treatment of Cancer QOL questionnaire and analyzed with a pattern mixture model using an intent-to-treat approach (at 6 and 12 months). Secondary outcomes included functional status, grade 3-5 treatment toxicity; health care use; satisfaction; cancer treatment plan modification; and overall survival. RESULTS: From March 2018 to March 2020, 350 participants were enrolled. Mean age was 76 years and 40.3% were female. Fifty-four percent started treatment with palliative intent. Eighty-one (23.1%) patients died. GAM did not improve QOL (global QOL of 4.4 points [95% CI, 0.9 to 8.0] favoring the control arm). There was also no difference in survival, change in treatment plan, unplanned hospitalization/emergency department visits, and treatment toxicity between groups. CONCLUSION: GAM did not improve QOL. Most intervention group participants received GA on or after treatment initiation per patient request. Considering recent completed trials, GA may have benefit if completed before treatment selection. The COVID-19 pandemic may have affected our QOL outcome and intervention delivery for some participants.

The Evolution of Geriatric Oncology and Geriatric Assessment over the Past Decade.

Cancer is predominantly a disease of aging, and older adults represent the majority of cancer diagnoses and deaths. Older adults with cancer differ significantly from younger patients, leading to important distinctions in cancer treatment planning and decision-making. As a consequence, the field of geriatric oncology has blossomed and evolved over recent decades, as the need to bring personalized cancer care to older adults has been increasingly recognized and a focus of study. The geriatric assessment (GA) has become the cornerstone of geriatric oncology research, and the past year has yielded promising results regarding the implementation of GA into routine cancer treatment decisions and outcomes for older adults. In this article, we provide an overview of the field of geriatric oncology and highlight recent breakthroughs with the use of GA in cancer care. Further work is needed to continue to provide personalized, evidence-based care for each older adult with cancer.

Geriatric assessment-informed treatment decision making and downstream outcomes: what are the research priorities?

PURPOSE OF REVIEW: Geriatric assessment (GA) can predict outcomes relevant to patients and clinicians but is not widely used. The objective of this review is to summarize the evidence supporting use of GA to facilitate decision making and improve outcomes and identify gaps that need to be addressed to further bolster the rationale for the use of GA. RECENT FINDINGS: Recently several randomized controlled studies exploring the impact of GA-directed care have been reported. Although GA-directed care has not been shown to improve survival, it can decrease moderate to severe toxicity from chemotherapy, increase the likelihood of completing planned chemotherapy and improve quality of life without adversely affecting survival. In the surgical setting, GA-directed care may decrease duration of hospitalization, but does not affect rates of re-hospitalization. SUMMARY: GA-directed care can improve patient-important outcomes compared to usual care. However, more research on whether these findings apply to other contexts and whether GA-directed care can improve other outcomes important to patients, such as function and cognition, is needed. Also more clarity about how oncologic treatments should be modified based on results of a GA are needed if oncologists are to utilize this information effectively to obtain the reported results.

Integration of geriatric assessment into clinical oncology practice: A scoping review.

Sixty percent of newly diagnosed cancers occur in older adults and more complex planning is required to sustain quality care for older populations. Individualized care incorporating geriatric assessment can predict early mortality and treatment toxicity for older cancer patients. We mapped and summarized the available evidence on the integration of geriatric assessment into clinical oncology practice, and ascertained which domains have been implemented. We systematically searched bibliographic databases and trial registries for reports of clinical studies, clinical practice guidelines, systematic and non-systematic reviews, and grey literature published in English. We gathered data on study characteristics, geriatric domains and strategies evaluated, and relevant study objectives and findings. From a total of 10,124 identified citations, 38 articles met our eligibility criteria, 3 of which were clinical practice guidelines. Nearly half of these articles came from the United States. Domains of the geriatric assessment implemented in studies ranged from 1 to 12, with varied combinations. We identified 27 studies on strategies for implementing geriatric assessment and 24 studies on feasibility of implementing geriatric assessment, into clinical oncology practice. We also identified 3 main geriatric assessment models: 2 from the United States and 1 from Australia. Furthermore, we identified 2 reviews that reported varied components of geriatric assessment models. There is increasingly robust evidence to implement formal geriatric assessment in oncology practice. There remains a great deal of variation in the tools recommended to address each of the domains in a geriatric assessment, with only 1 guideline (American Society of Clinical Oncology guideline) settling on a specific best practice. Protocol registration: Open Science Framework osf.io/mec93.

Clinical and Cost-effectiveness of a Comprehensive geriatric assessment and management for Canadian elders with Cancer-the 5C study: a study protocol for a randomised controlled phase III trial.

INTRODUCTION: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting. TRIAL DESIGN: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation. PARTICIPANTS: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months. INTERVENTION: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months. OBJECTIVE: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care. RANDOMISATION: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other). OUTCOME: Quality of life. SECONDARY OUTCOMES: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival. PLANNED ANALYSIS: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods. ETHICS AND DISSEMINATION: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings. TRIAL REGISTRATION NUMBER: NCT03154671.

What Every Oncologist Should Know About Geriatric Assessment for Older Patients With Cancer: Young International Society of Geriatric Oncology Position Paper.

Aging is a heterogeneous process. Most newly diagnosed cancers occur in older adults, and it is important to understand a patient's underlying health status when making treatment decisions. A geriatric assessment provides a detailed evaluation of medical, psychosocial, and functional problems in older patients with cancer. Specifically, it can identify areas of vulnerability, predict survival and toxicity, assist in clinical treatment decisions, and guide interventions in routine oncology practice; however, the uptake is hampered by limitations in both time and resources, as well as by a lack of expert interpretation. In this review, we describe the utility of geriatric assessment by using an illustrative case and provide a practical approach to geriatric assessment in oncology.

Geriatrics fellowship training and the role of geriatricians in older adult cancer care: A survey of geriatrics fellowship directors.

The number of older adults with cancer is growing, necessitating more collaborative training in geriatric principles and cancer care. The authors administered a web-based survey to U.S. geriatrics program directors (PDs) addressing cancer-specific training and perspectives on optimal training content and roles for geriatricians in cancer care. Of 140 PDs contacted, 67 (48%) responded. Topics considered very important in training included cancer screening (79%) and cancer-related pain management (70%). Respondents strongly agreed that some of the geriatrician's roles in cancer care included assessing functional status (64%) and assessing physical/cognitive function for goals of care (64%). About one half (54%) agreed that having a standardized geriatric oncology curriculum overall was important. The presence of a geriatric oncologist, requiring cancer-based rotations, being affiliated with a cancer center, or being internal versus family medicine-based did not affect this response. Despite this high level of support, cancer-related skills and knowledge warrant better definition and integration into current geriatrics training. This survey establishes potential areas for future educational collaborations between geriatrics and oncology training programs.

A multi-center pragmatic, randomized, feasibility trial comparing standard of care schedules of filgrastim administration for primary febrile neutropenia prophylaxis in early-stage breast cancer.

INTRODUCTION: The most effective duration of filgrastim as primary febrile neutropenia (FN) prophylaxis in early breast cancer (EBC) patients is unknown. Despite significant differences in cost and toxicity, no prospective trial has been performed to optimize practice. We assessed the feasibility of using a novel pragmatic trial model to compare the most commonly used schedules of filgrastim. METHODS: Early breast cancer patients receiving chemotherapy were randomized to 5, 7, or 10 days of filgrastim as primary FN prophylaxis. The trial methodology integrated broad eligibility criteria, simply defined endpoints, an integrated consent model incorporating oral consent, and web-based randomization in the clinic. Feasibility was reflected through a combination of primary endpoints including patient and physician engagement (if > 50% of appropriate patients approached agree to participate, and if > 50% of physicians approached patients for the study). Secondary endpoints included the first occurrence rates of FN, treatment-related hospital admission, or chemotherapy dose reductions/delays/discontinuation. RESULTS: From May 2015 to August 2016, 142/149 (95.3%) patients approached agreed to participate and were randomized. Seventeen of 24 (70.8%) medical oncologists approached and randomized patients. The 142 patients received a total of 495 cycles of chemotherapy. Aggregate incidences of a first event by patient were FN (8/142, 5.6%), treatment-related hospitalization (6/142, 4.2%), chemotherapy discontinuation (7/142, 4.9%), chemotherapy delays (5/142, 3.5%), and chemotherapy dose reduction (18/142, 12.7%). Overall, 31.7% (45/142) of patients and 9.0% (45/495) of chemotherapy cycles were associated with one of these first events. CONCLUSION: This study met its feasibility endpoints. This novel pragmatic trial approach offers a means of comparing standard of care treatments in a practical and cost-effective manner. The trial will now be expanded to compare rates of FN between the three filgrastim schedules. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02428114.

Are Disagreements in Caregiver and Patient Assessment of Patient Health Associated with Increased Caregiver Burden in Caregivers of Older Adults with Cancer?

BACKGROUND: As patients age, caregivers increasingly provide essential support and patient information. We sought to determine if patient-caregiver assessments of patient health differ and if differences contribute to burden in caregivers of older adults with cancer. MATERIALS AND METHODS: One hundred patients, aged ≥65, and their caregivers independently assessed patient function, comorbidity, nutrition, social activity, social support, and mental health. Caregivers completed the Caregiver Strain Index (CSI). Patient-caregiver assessments were compared using the Wilcoxon signed rank test and paired t test. Association between caregiver burden and differences between patient-caregiver assessments was examined using generalized linear regression. RESULTS: Median patient age was 70 (range 65-91) and 70% had advanced disease. Sixty percent of patients reported requiring help with instrumental activities of daily living (IADLs); most had good social support (median Medical Outcomes Study [MOS]-Social Support Survey score 92) and mental health (median Mental Health Inventory score 85).Caregivers were a median age of 66 (range 28-85), 73% female, 68% spousal caregivers, and 79% lived with the patient. Caregivers rated patients as having poorer physical function (more IADLs dependency [p = .008], lower Karnofsky Performance Status [p = .02], lower MOS-Physical Function [p < .0001]), poorer mental health (p = .0002), and having more social support (p = .03) than patients themselves. Three-quarters of caregivers experienced some caregiver burden (mean CSI score 3.1). Only differences in patient-caregiver assessment of the patient's need for help with IADLs were associated with increased caregiver burden (p = .03). CONCLUSION: Patient-caregiver assessments of patient function, mental health, and social support differ. However, only differences in assessment of IADLs dependency were associated with increased caregiver burden. IMPLICATIONS FOR PRACTICE: As patients age, there is a higher incidence of frailty and cognitive impairments. As a result, caregivers play an increasingly vital role in providing information about patient health to healthcare providers, which is used to help healthcare providers tailor treatments and optimize patient health. These findings highlight that caregiver reporting in older adults with cancer may not replace patient reporting in those older adults who are otherwise able to self-report. Furthermore, clinicians should check for caregiver burden in caregivers who report providing more help with instrumental activities of daily living than patients themselves report and provide appropriate support as needed.

Global geriatric oncology: Achievements and challenges.

The aging of the population is a global challenge. The number of older adults is rapidly growing, leading to an increase in the prevalence of noncommunicable diseases associated with aging, such as cancer. Worldwide, older adults account for approximately half of all cancer cases, and this proportion is projected to increase globally. Furthermore, the majority of older adults live in less developed regions, where health systems are generally ill-equipped to provide care for complex chronic conditions. Worldwide, there is paucity of geriatric training, and most of the oncology workforce lacks the skills and knowledge to provide comprehensive care for older patients. Various initiatives aimed at providing adequate clinical care for older adults, increasing the geriatric skills and knowledge of healthcare professionals, and developing geriatric oncology research, have been successfully implemented. However, most developments in geriatric oncology have taken place in high-income countries, and there are still large inequalities in the availability of clinical, educational, and research initiatives across different regions of the world. This article provides an overview of geriatric oncology initiatives in Asia, Europe, Australia and New Zealand, Latin America, and the United States and Canada. Understanding the achievements and challenges of geriatric oncology around the world, and fostering international collaboration in research and training are essential for improving the care of all older adults with cancer.

Comprehensive Geriatric Assessment in the Older Adult with Cancer: A Review.

CONTEXT: The number of older adults with cancer is expected to increase rapidly in the upcoming decades. Aging is heterogeneous and chronological age is often not reflective of biological age. A comprehensive geriatric assessment (CGA) is an in-depth assessment of multiple domains of health that results in better assessment of a patient's overall health and fitness and allows directed intervention to improve patient outcomes. OBJECTIVE: To review the value of CGA for older adults with cancer, CGA composition and tools that can be utilized, and the feasibility of including CGA in oncologic practice. EVIDENCE ACQUISITION: The currently available evidence on CGA for older adults with cancer was reviewed. EVIDENCE SYNTHESIS: A CGA can highlight unidentified health problems and identify patients at higher risk of mortality, functional decline, surgical complications, chemotherapy intolerance, and chemotherapy toxicity. It has been shown that CGA is feasible in the oncology clinic, but geriatric screening tools may be useful to specifically identify patients who would benefit from a full CGA. CONCLUSIONS: CGA is feasible and can identify patients at higher risk of adverse events such as mortality, functional decline, surgical complications, and chemotherapy toxicity. Clinicians should consider incorporating CGA when assessing and caring for older adults with cancer. PATIENT SUMMARY: In this report, we review the benefits of a comprehensive geriatric assessment (CGA), a detailed in-depth assessment that identifies health problems not typically identified during routine assessments, for older adults with cancer. We describe the different domains of the CGA and suggest tools to utilize, as well as ways to incorporate CGA into the cancer care setting.