Acute Genital Ulceration After Severe Acute Respiratory Syndrome Coronavirus 2 Vaccination and Infection.

Reactive, nonsexually related acute genital ulceration, also known as Lipschütz ulcer, is a nonsexually related ulceration involving the vulva, most commonly affecting girls and adolescent women in response to infection. Herein, we describe 3 female patients with acute genital ulceration occurring after severe acute respiratory syndrome coronavirus 2 vaccination or natural infection.

A randomized clinical trial comparing physician-directed or fixed-dose steroid replacement strategies for incomplete dexamethasone dosing prior to docetaxel chemotherapy.

PURPOSE: Prior to docetaxel chemotherapy, incomplete dosing of steroid premedication is common. The lack of standardized steroid replacement strategies can lead to variability in care and delays in starting docetaxel. METHODS: This randomized trial compared physician-directed with fixed-dose dexamethasone. Patients who had missed at least one dose of steroid premedication were randomized to physician-directed replacement (any choice of steroid, dose or route) or to dexamethasone 8 mg oral before starting docetaxel. The primary outcome was time from randomization to starting docetaxel. Secondary outcomes included rates of acute and delayed hypersensitivity reactions, fluid retention and skin toxicity. RESULTS: Of 60 eligible patients, 30 (50%) and 30 (50%) were randomized to physician-directed and fixed-dose arms, respectively. Overall tumour types: breast (42 [70%]), gastrointestinal (7 [12%]), prostate (7 [12%]) and lung (3 [7%]). Dexamethasone was most commonly incompletely taken with cycles 1 (28 [48%]) and 2 (13 [22%]) of docetaxel. Seven different replacement strategies were used in the physician-choice arm. Patients in the fixed-dose arm received docetaxel a mean of 21.2 (95% CI for the difference is 2.1 to 44.6) minutes earlier than the physician-choice arm (p = 0.033 Wilcoxon rank sum test or p = 0.073 two-sample t test). Median time to docetaxel was 47.5 vs 61 min (mean 62.2 vs 83.4 min) by arm, respectively. No significant difference in toxicity rates was observed. CONCLUSION: While not meeting our predefined criteria of improving the time from randomization to starting docetaxel by 30 min, the fixed-dose replacement strategy reduced both the time to starting docetaxel and treatment variability. Fixed dosing with oral dexamethasone 8 mg should be the preferred standard of care. REGISTRATION: www.clinicaltrials.gov NCT02815319 REGISTRATION DATE: June 28, 2016.

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.

National Survey Among Radiation Oncology Residents Related to Their Needs in Geriatric Oncology.

Currently, there is no formal curriculum addressing geriatric oncology within Canadian radiation oncology (RO) residency programs. Knowledge related to geriatric medicine may help radiation oncologists modify RT based on frailty status and geriatric considerations. Understanding specific learning needs allow program coordinators to align the current curriculum with residents' geriatric oncology learning needs. The purpose of this study is to determine the geriatric oncology educational needs of the Canadian RO residents and to inform Canadian RO residency training. A cross-sectional survey, with Likert, multiple choice, and open-ended questions, was pretested and distributed electronically by program directors to Canadian RO residents over 6 weeks. Responses were analyzed with descriptive statistics and common themes. One-hundred and thirty-five Canadian RO residents were contacted and 63 responded (47%). Half (49%) lacked confidence managing the elderly with multiple comorbidities, polypharmacy, functional and cognitive impairment, and challenging social circumstances;73% agreed additional training would be helpful. Forty-four percent lacked confidence regarding psychogeriatric referrals, fall prevention, palliative and hospice care, and community resources preventing re-hospitalization; 63% agreed additional training would be helpful. Seventy-six percent believed discussion groups, continuing education, geriatric oncology electives, and journal clubs would provide learning opportunities. Seventy-one percent agreed integrating geriatric assessment into RO curricula would improve care. Seventy-nine percent believed geriatric oncology principles have not been adequately integrated into radiation oncology curricula. There are significant gaps specific to geriatric assessment and management of older cancer patients in the current Canadian RO curricula. Most residents agreed that it is important to integrate geriatric oncology training to improve and personalize the care of older cancer patients.

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.

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.

The utility of abbreviated patient-reported outcomes for predicting survival in early stage colorectal cancer.

BACKGROUND: Patient-reported outcomes (PROs) are increasingly used in clinical settings. Prior research suggests that PROs collected at baseline may be associated with cancer survival, but most of those studies were conducted in patients with breast or lung cancer. The objective of this study was to determine the correlation between prospectively collected PROs and cancer-specific outcomes in patients with early stage colorectal cancer. METHODS: Patients who had newly diagnosed stage II or III colorectal cancer from 2009 to 2010 and had a consultation at the British Columbia Cancer Agency completed the brief Psychosocial Screen for Cancer (PSSCAN) questionnaire, which collects data on patients' perceived social supports, quality of life (QOL), anxiety and depression, and general health. PROs from the PSSCAN were linked with the Gastrointestinal Cancers Outcomes Database, which contains information on patient and tumor characteristics, treatment details, and cancer outcomes. Cox regression models were constructed for overall survival (OS), and Fine and Gray regression models were developed for disease-specific survival (DSS). RESULTS: In total, 692 patients were included. The median patient age was 67 years (range, 26-95 years), and the majority had colon cancer (61%), were diagnosed with stage III disease (54%), and received chemotherapy (58%). In general, patients felt well supported and reported good overall health and QOL. On multivariate analysis, increased fatigue was associated with worse OS (hazard ratio [HR], 1.99; P = .00007) and DSS (HR, 1.63; P = .03), as was lack of emotional support (OS: HR, 4.36; P = .0003; DSS: HR, 1.92; P = .02). CONCLUSIONS: Although most patients described good overall health and QOL and indicated that they were generally well supported, patients who experienced more pronounced fatigue or lacked emotional support had a higher likelihood of worse OS and DSS. These findings suggest that abbreviated PROs can inform and assist clinicians to identify patients who have a worse prognosis and may need more vigilant follow-up. Cancer 2017;123:1839-1847. © 2017 American Cancer Society.

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.

The Senior Toronto Oncology Panel (STOP) Study: Research Participation for Older Adults With Cancer and Caregivers.

Background: Patient engagement in research may lead to better-designed studies and improved health outcomes. The objectives of this study were to identify the research priorities of older adults with cancer (OAWCs) and their caregivers and examine how to engage these individuals in research teams and what supports are needed. Methods: We conducted 3 public meetings and 7 focus groups to delineate research priorities and the supports needed to facilitate integration of OAWCs and their caregivers on research teams. Results: A total of 33 older adults and 19 caregivers attended a public meeting and 27 older adults and 17 caregivers participated in a focus group. Most of the OAWCs and their caregivers had never participated in research before. Three themes were identified from the focus groups: (1) motivation to be on a team; (2) ability to make meaningful contributions; and (3) logistical considerations to facilitate engagement. Most participants were motivated to be a research team member and be involved in all steps of research if it could benefit them or future patients and caregivers. OAWCs and their caregivers were highly motivated to improve outcomes. Required logistics included flexibility regarding time and location, accessibility to computer technology, transportation support, materials worded in lay language, and attending/having short training sessions, as well as the presence of peer support. Conclusions: OAWCs and their caregivers are very motivated and willing to participate in research and to be research team members. Logistics and the social aspects of being on a team are important.

Factors associated with high burden in caregivers of older adults with cancer.

BACKGROUND: Older adults with cancer are vulnerable to functional decline, which places greater onus on caregivers. Few studies have prospectively examined burden in caregivers of older cancer patients. The objective of this study was to determine the factors associated with high caregiver burden. METHODS: In total, 100 caregivers of patients aged ≥65 years with cancer, who were recruited at a single institution, completed questionnaires gauging their perception of the patient's physical, emotional, and social health. The association between these items, cancer-related factors, sociodemographic factors, and caregiver burden (measured using the Caregiver Strain Index [CSI]) was determined through multivariate analysis. RESULTS: The median patient age was 70 years (range, 65-91 years), 70% of patients had advanced disease, and 98% were receiving treatment. Caregivers were mostly women (73%), spouses (68%), and lived with the patient (79%). The median amount of care provided was 10 hours per week. The mean CSI score (± standard deviation) was 3.1 ± 3.2. Most caregivers (75%) reported some burden, with 15% reporting high caregiver burden (CSI score, ≥7). In multivariate analysis, employed caregivers (odds ratio, 4.5; 95% confidence interval, 1.1-18.4; P = .04) and those caring for patients who required more help with instrumental activities of daily living (Older Americans Resources and Services-Instrumental Activities of Daily Living score, <12 of a possible 14; odds ratio, 12.4; 95% confidence interval, 2.4-62.5; P < .001) were more likely to experience high caregiver burden (CSI score, ≥7). CONCLUSIONS: Caregiver burden is common in those who care for older cancer patients. High burden is more likely in employed caregivers and in those who care for patients who require increased functional assistance. Further studies are needed to determine the unique challenges experienced by caregivers of older adults with cancer and potential interventions to alleviate burden in these caregivers.

Geriatric Oncology: A 5-Year Strategic Plan.

The increasing rate of the older adult population across the world over the next 20 years along with significant developments in the treatment of oncology will require a more granular understanding of the older adult population with cancer. The ASCO Geriatric Oncology Community of Practice (COP) herein provides an outline for the field along three fundamental pillars: education, research, and implementation, inspired by ASCO's 5-Year Strategic Plan. Fundamental to improving the understanding of geriatric oncology is research that intentionally includes older adults with clinically meaningful data supported by grants across all career stages. The increased knowledge base that is developed should be conveyed among health care providers through core competencies for trainees and continuing education for practicing oncologists. ASCO's infrastructure can serve as a resource for fellowship programs interested in acquiring geriatric oncology content and provide recommendations on developing training pathways for fellows interested in pursuing formalized training in geriatrics. Incorporating geriatric oncology into everyday practice is challenging as each clinical setting has unique operational workflows with barriers that limit implementation of valuable geriatric tools such as Geriatric Assessment. Partnerships among experts in quality improvement from the ASCO Geriatric Oncology COP, the Cancer and Aging Research Group, and ASCO's Quality Training Program can provide one such venue for implementation of geriatric oncology through a structured support mechanism. The field of geriatric oncology must continue to find innovative strategies using existing resources and partnerships to address the pressing needs of the older adult population with cancer to improve patient outcomes.

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.

Developing Sustainable Cancer and Aging Programs.

Geriatric assessment (GA) has been shown to decrease toxicity from systemic therapy, improve completion of chemotherapy, and reduce hospitalizations in older adults with cancer. Given the aging of the cancer population, this has the potential to have a positive impact on the care of a large swath of patients seen. Despite endorsement by several international societies, including the American Society of Clinical Oncology, uptake of GA has been low. Lack of knowledge, time, and resources has been cited as reasons for this. Although challenges to developing and implementing a cancer and aging program vary depending on the health care context, GA is adaptable to every health care context from low- to high-resource settings, as well as those in which geriatric oncology is a well-established or just emerging field. We provide an approach for clinicians and administrators to develop, implement, and sustain aging and cancer programs in a doable and sustainable way.

A Case Report of an Isolated Cardiac Metastasis in a Patient with Esophageal Carcinoma.

A 76-year-old Caucasian male presented with syncope, intermittent melena, anemia, and unexplained weight loss. Esophagogastroduodenoscopy revealed a friable non-obstructing esophageal tumor that appeared thickened on computed tomography (CT). Biopsies confirmed a poorly differentiated carcinoma. Fluorine-18 fluorodeoxyglucose positron emission tomography/CT (F-18 FDG PET/CT) showed intense FDG avidity with a maximum standardized uptake value (SUVmax) of 23. Although CT did not identify any lymphadenopathy or distant metastases, a mildly enhancing lobulated circumscribed mass with no internal calcification was incidentally identified in the left atrium. Cardiac magnetic resonance imaging (MRI) favored myxoma over thrombus given the signal characteristics and mild enhancement; however, F-18 FDG PET/CT showed an SUVmax of 18, more consistent with a metastasis. The cardiac mass was resected and shown to be a metastatic focus of poorly differentiated carcinoma, histologically identical to the esophageal mass. He received a single 8 Gray (Gy) fraction of urgent hemostatic radiotherapy for his primary tumor followed by palliative chemotherapy with cisplatin, capecitabine, and pembrolizumab. He was readmitted for transfusion due to recurrent bleeding from his primary tumor and given a second urgent hemostatic fraction of 8 Gy for stabilization. Systemic therapy was eventually discontinued due to declining performance status. He received consolidative palliative radiotherapy (20Gy in five fractions) but continued to deteriorate over the next three months and died in hospice, ten months from the time of his initial presentation.

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.

Key Considerations for the Treatment of Advanced Breast Cancer in Older Adults: An Expert Consensus of the Canadian Treatment Landscape.

The prevalence of breast cancer amongst older adults in Canada is increasing. This patient population faces unique challenges in the management of breast cancer, as older adults often have distinct biological, psychosocial, and treatment-related considerations. This paper presents an expert consensus of the Canadian treatment landscape, focusing on key considerations for optimizing selection of systemic therapy for advanced breast cancer in older adults. This paper aims to provide evidence-based recommendations and practical guidance for healthcare professionals involved in the care of older adults with breast cancer. By recognizing and addressing the specific needs of older adults, healthcare providers can optimize treatment outcomes and improve the overall quality of care for this population.

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.