Objective To evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer. Design Pragmatic, cluster randomised trial. Setting 20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care. Participants All patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires. Interventions Proactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle. Main outcome measures The primary outcome, cluster level mean number of visits to the emergency department or admissions to hospital per patient during the whole course of chemotherapy treatment, was evaluated with routinely available administrative healthcare data. Secondary patient reported outcomes included toxicity, self-efficacy, and quality of life. Results Baseline characteristics of participants were similar in the intervention (n=944) and control arms (n=1214); 22% were older than 65 years. Penetration (that is, the percentage of patients who received the intervention at each centre) was 50-86%. Mean number of visits to the emergency department or admissions to hospital per patient was 0.91 (standard deviation 0.28) in the intervention arm and 0.94 (0.40) in the control arm (P=0.94); 47% (1014 of 2158 patients) had at least one visit to the emergency department or a hospital admission during chemotherapy. Among 580 participants who completed the patient reported outcome questionnaires, at least one grade 3 toxicity was reported by 48% (134 of 278 patients) in the intervention arm and by 58% (163 of 283) in the control arm. No differences in self-efficacy, anxiety, or depression were found. Compared with baseline, the functional assessment of cancer therapy trial outcome index decreased by 6.1 and 9.0 points in the intervention and control participants, respectively. Conclusions Proactive, telephone based management of toxicities during chemotherapy did not result in fewer visits to the emergency department or hospital admissions. With the rapid rise in remote care because of the covid-19 pandemic, identifying scalable strategies for remote management of patients during cancer treatment is particularly relevant. Trial registration ClinicalTrials.gov NCT02485678 .

IMPORTANCE Emergency department visits and hospitalizations after starting systemic therapy for cancer are frequent, undesirable, and costly. A score to quantify the risk of needing acute care can inform decision-making and facilitate the development of preventive interventions. OBJECTIVE To develop and validate a score to predict early use of acute care after initiating systemic therapy for cancer. DESIGN, SETTING, AND PARTICIPANTS A retrospective population-based cohort study was conducted between July 1, 2014, and June 30, 2015. Patients with cancer were eligible if they started a new systemic therapy for cancer, regardless of line of therapy. A total of 12 162 patients in Southwestern Ontario, Canada, formed the development cohort and 15 845 patients in Northeastern Ontario formed the validation cohort. Data analysis was conducted from December 1, 2016, to August 10, 2019. EXPOSURES The Prediction of Acute Care Use During Cancer Treatment (PROACCT) score was created based on logistic regression in the development cohort. Combinations of cancer type and regimens were grouped into quintiles based on risk of needing acute care. The score was assessed in the validation cohort. MAIN OUTCOMES AND MEASURES At least 1 emergency department visit or hospitalization within 30 days after starting systemic therapy for cancer identified from administrative databases. RESULTS Among the 12 162 patients in the development cohort, 6903 were women and 5259 were men (mean [SD] age, 62.9 [12.6] years); among the 15 845 patients in the validation cohort, 9025 were women and 6820 were men (mean [SD] age, 62.9 [12.6] years). Use of acute care occurred within 30 days after initiation of systemic therapy in 3039 patients (25.0%) in the development cohort and 4212 patients (26.6%) in the validation cohort. Three characteristics predicted early use of acute care and formed the PROACCT score: combination of cancer type and treatment regimen, age, and emergency department visits in the prior year (C statistic, 0.67; 95% CI, 0.66-0.69; P < .001). Other characteristics including patient-reported symptoms did not improve performance. In the validation cohort, the PROACCT score was associated with use of acute care (odds ratio per point increase, 1.22; 95% CI, 1.20-1.24; P < .001), had a C statistic of 0.61 (95% CI, 0.60-0.62; P < .001), was reasonably calibrated, and provided net benefit in decision curve analysis. CONCLUSIONS AND RELEVANCE The PROACCT score predicted the risk of early use of acute care in patients starting systemic treatment for cancer and could be incorporated at the point of care to select patients for preventive interventions. Future studies should validate the PROACCT score in other settings.

Background The disruption of health services due coronavirus disease (COVID) is expected to dramatically alter cancer care; however, the implications for care quality and outcomes remain poorly understood. We undertook a scoping review to evaluate what is known in the literature about how cancer treatment has been modified as a result of the COVID pandemic in patients receiving treatment for solid tumours, and what domains of quality of care are most impacted. Methods Citations were retrieved from MEDLINE and EMBASE (1 Jan 2019 to 28 Oct 2020), utilizing search terms grouped by key concept (oncology, treatment, treatment modifications and COVID). Articles were excluded if they dealt exclusively with management of COVID-positive patients, modifications to cancer screening, diagnosis or supportive care, or were not in English. Articles reporting on guidelines, consensus statements, recommendations, literature reviews, simulations or predictive models, or opinions in the absence of accompanying information on experience with treatment modifications in practice were excluded. Treatment modifications derived from the literature were stratified by modality (surgery, systemic therapy and radiotherapy) and thematically grouped. To understand what areas of quality were most impacted, modifications were mapped against the Institute of Medicine’s quality domains. Where reported, barriers and facilitators were abstracted and thematically grouped to understand drivers of treatment modifications. Findings were synthesized into a logic model to conceptualize the inter-relationships between different modifications, as well as their downstream impacts on outcomes. Results In the 87 retained articles, reductions in outpatients visits (26.4%), and delays/deferrals were commonly reported across all treatment modalities (surgery: 50%; systemic therapy: 55.8%; radiotherapy: 56.7%); as were reductions in surgical capacity (57.1%), alternate systemic regimens with longer treatment intervals or use of oral agents (19.2%), and the use of hypofractionated radiotherapy regimens (40.0%). Delivery of effective, timely and equitable care were the quality domains found to be most impacted. The most commonly reported facilitator of maintaining cancer care delivery levels was the shift to virtual models of care (62.1%), while patient-initiated deferrals and cancellations (34.8%), often due to fear of contracting COVID (60.9%), was a commonly reported barrier. Conclusions As it will take a considerable amount of time for the cancer system to resume capacity and adjust models of care in response to the pandemic, these treatment delays and modifications will likely be prolonged, and will negatively impact quality of care and patient outcomes.