TOward a comPrehensive supportive Care intervention for Older men with metastatic Prostate cancer (TOPCOP3): A pilot randomized controlled trial and process evaluation.

INTRODUCTION: Current management of metastatic prostate cancer (mPC) includes androgen receptor axis-targeted therapy (ARATs), which is associated with substantial toxicity in older adults. Geriatric assessment and management and remote symptom monitoring have been shown to reduce toxicity and improve quality of life in patients undergoing chemotherapy, but their efficacy in patients being treated with ARATs has not been explored. The purpose of this study is to examine whether these interventions, alone or in combination, can improve treatment tolerability and quality of life (QOL) for older adults with metastatic prostate cancer on ARATs. MATERIALS AND METHODS: TOPCOP3 is a multi-centre, factorial pilot clinical trial coupled with an embedded process evaluation. The study includes four treatment arms: geriatric assessment and management (GA + M); remote symptom monitoring (RSM); geriatric assessment and management plus remote symptom monitoring; and usual care and will be followed for six months. The aim is to recruit 168 patients between two cancer centres in Toronto, Canada. Eligible participants will be randomized equally via REDCap. Participants in all arms will complete a comprehensive baseline assessment upon enrollment following the Geriatric Core dataset, as well as follow-up assessments at 1.5, 3, 4.5, and 6 months. The co-primary outcomes will be grade 3-5 toxicity and QOL. Toxicities will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. QOL will be measured by patient self-reporting using the EuroQol 5 dimensions of health questionnaire. Secondary outcomes include fatigue, insomnia, and depression. Finally, four process evaluation outcomes will also be observed, namely feasibility, fidelity, and acceptability, along with implementation barriers and facilitators. DISCUSSION: Data will be collected to observe the effects of GA + M and RSM on QOL and toxicities experienced by older adults receiving ARATs for metastatic prostate cancer. Data will also be collected to help the design and conduct of a definitive multicentre phase III randomized controlled trial. This study will extend supportive care interventions for older adults with cancer into new areas and inform the design of larger trials. TRIAL REGISTRATION: The trial is registered at clinicaltrials.gov (registration number: NCT05582772).

Socioeconomic Status, Palliative Care, and Death at Home Among Patients With Cancer Before and During COVID-19.

Importance: The COVID-19 pandemic had a profound impact on the delivery of cancer care, but less is known about its association with place of death and delivery of specialized palliative care (SPC) and potential disparities in these outcomes. Objective: To evaluate the association of the COVID-19 pandemic with death at home and SPC delivery at the end of life and to examine whether disparities in socioeconomic status exist for these outcomes. Design, Setting, and Participants: In this cohort study, an interrupted time series analysis was conducted using Ontario Cancer Registry data comprising adult patients aged 18 years or older who died with cancer between the pre-COVID-19 (March 16, 2015, to March 15, 2020) and COVID-19 (March 16, 2020, to March 15, 2021) periods. The data analysis was performed between March and November 2023. Exposure: COVID-19-related hospital restrictions starting March 16, 2020. Main Outcomes and Measures: Outcomes were death at home and SPC delivery at the end of life (last 30 days before death). Socioeconomic status was measured using Ontario Marginalization Index area-based material deprivation quintiles, with quintile 1 (Q1) indicating the least deprivation; Q3, intermediate deprivation; and Q5, the most deprivation. Segmented linear regression was used to estimate monthly trends in outcomes before, at the start of, and in the first year of the COVID-19 pandemic. Results: Of 173 915 patients in the study cohort (mean [SD] age, 72.1 [12.5] years; males, 54.1% [95% CI, 53.8%-54.3%]), 83.7% (95% CI, 83.6%-83.9%) died in the pre-COVID-19 period and 16.3% (95% CI, 16.1%-16.4%) died in the COVID-19 period, 54.5% (95% CI, 54.2%-54.7%) died at home during the entire study period, and 57.8% (95% CI, 57.5%-58.0%) received SPC at the end of life. In March 2020, home deaths increased by 8.3% (95% CI, 7.4%-9.1%); however, this increase was less marked in Q5 (6.1%; 95% CI, 4.4%-7.8%) than in Q1 (11.4%; 95% CI, 9.6%-13.2%) and Q3 (10.0%; 95% CI, 9.0%-11.1%). There was a simultaneous decrease of 5.3% (95% CI, -6.3% to -4.4%) in the rate of SPC at the end of life, with no significant difference among quintiles. Patients who received SPC at the end of life (vs no SPC) were more likely to die at home before and during the pandemic. However, there was a larger immediate increase in home deaths among those who received no SPC at the end of life vs those who received SPC (Q1, 17.5% [95% CI, 15.2%-19.8%] vs 7.6% [95% CI, 5.4%-9.7%]; Q3, 12.7% [95% CI, 10.8%-14.5%] vs 9.0% [95% CI, 7.2%-10.7%]). For Q5, the increase in home deaths was significant only for patients who did not receive SPC (13.9% [95% CI, 11.9%-15.8%] vs 1.2% [95% CI, -1.0% to 3.5%]). Conclusions and Relevance: These findings suggest that the COVID-19 pandemic was associated with amplified socioeconomic disparities in death at home and SPC delivery at the end of life. Future research should focus on the mechanisms of these disparities and on developing interventions to ensure equitable and consistent SPC access.

Machine Learning to Allocate Palliative Care Consultations During Cancer Treatment.

PURPOSE: For patients with advanced cancer, early consultations with palliative care (PC) specialists reduce costs, improve quality of life, and prolong survival. However, capacity limitations prevent all patients from receiving PC shortly after diagnosis. We evaluated whether a prognostic machine learning system could promote early PC, given existing capacity. METHODS: Using population-level administrative data in Ontario, Canada, we assembled a cohort of patients with incurable cancer who received palliative-intent systemic therapy between July 1, 2014, and December 30, 2019. We developed a machine learning system that predicted death within 1 year of each treatment using demographics, cancer characteristics, treatments, symptoms, laboratory values, and history of acute care admissions. We trained the system in patients who started treatment before July 1, 2017, and evaluated the potential impact of the system on PC in subsequent patients. RESULTS: Among 560,210 treatments received by 54,628 patients, death occurred within 1 year of 45.2% of treatments. The machine learning system recommended the same number of PC consultations observed with usual care at the 60.0% 1-year risk of death, with a first-alarm positive predictive value of 69.7% and an outcome-level sensitivity of 74.9%. Compared with usual care, system-guided care could increase early PC by 8.5% overall (95% CI, 7.5 to 9.5; P < .001) and by 15.3% (95% CI, 13.9 to 16.6; P < .001) among patients who live 6 months beyond their first treatment, without requiring more PC consultations in total or substantially increasing PC among patients with a prognosis exceeding 2 years. CONCLUSION: Prognostic machine learning systems could increase early PC despite existing resource constraints. These results demonstrate an urgent need to deploy and evaluate prognostic systems in real-time clinical practice to increase access to early PC.

Prevalence and drivers of nurse and physician distress in cardiovascular and oncology programmes at a Canadian quaternary hospital network during the COVID-19 pandemic: a quality improvement initiative.

OBJECTIVES: To assess the prevalence and drivers of distress, a composite of burnout, decreased meaning in work, severe fatigue, poor work-life integration and quality of life, and suicidal ideation, among nurses and physicians during the COVID-19 pandemic. DESIGN: Cross-sectional design to evaluate distress levels of nurses and physicians during the COVID-19 pandemic between June and August 2021. SETTING: Cardiovascular and oncology care settings at a Canadian quaternary hospital network. PARTICIPANTS: 261 nurses and 167 physicians working in cardiovascular or oncology care. Response rate was 29% (428 of 1480). OUTCOME MEASURES: Survey tool to measure clinician distress using the Well-Being Index (WBI) and additional questions about workplace-related and COVID-19 pandemic-related factors. RESULTS: Among 428 respondents, nurses (82%, 214 of 261) and physicians (62%, 104 of 167) reported high distress on the WBI survey. Higher WBI scores (≥2) in nurses were associated with perceived inadequate staffing (174 (86%) vs 28 (64%), p=0.003), unfair treatment, (105 (52%) vs 11 (25%), p=0.005), and pandemic-related impact at work (162 (80%) vs 22 (50%), p<0.001) and in their personal life (135 (67%) vs 11 (25%), p<0.001), interfering with job performance. Higher WBI scores (≥3) in physicians were associated with perceived inadequate staffing (81 (79%) vs 32 (52%), p=0.001), unfair treatment (44 (43%) vs 13 (21%), p=0.02), professional dissatisfaction (29 (28%) vs 5 (8%), p=0.008), and pandemic-related impact at work (84 (82%) vs 35 (56%), p=0.001) and in their personal life (56 (54%) vs 24 (39%), p=0.014), interfering with job performance. CONCLUSION: High distress was common among nurses and physicians working in cardiovascular and oncology care settings during the pandemic and linked to factors within and beyond the workplace. These results underscore the complex and contextual aspects of clinician distress, and the need to develop targeted approaches to effectively address this problem.

Virtual Cancer Care Beyond the COVID-19 Pandemic: Patient and Staff Perspectives and Recommendations.

PURPOSE: COVID-19 catalyzed rapid implementation of virtual cancer care (VC); however, work is needed to inform long-term adoption. We evaluated patient and staff experiences with VC at a large urban, tertiary cancer center to inform recommendations for postpandemic sustainment. METHODS: All physicians who had provided VC during the pandemic and all patients who had a valid e-mail address on file and at least one visit to the Princess Margaret Cancer Centre in Toronto, Canada, in the preceding year were invited to complete a survey. Interviews and focus groups with patients and staff across the cancer center were analyzed using qualitative descriptive analysis and triangulated with survey findings. RESULTS: Response rates for patients and physicians were 15% (2,343 of 15,169) and 41% (100 of 246), respectively. A greater proportion of patients than physicians were satisfied with VC (80.1 v 53.4%; P < .01). In addition, fewer patients than physicians felt that virtual visits were worse than those conducted in person (28.0 v 43.4%; P < .01) and that telephone and video visits negatively affected the human interaction that they valued (59.8% v 82.0%; P < .01). Major barriers to VC for patients were respect for care preferences and personal boundaries, accessibility, and equitable access. For staff, major barriers included a lack of role clarity, dedicated resources (space and technology), integration of nursing and allied health, support (administrative, clinical, and technical), and guidance on appropriateness of use. CONCLUSION: Patient and staff perceptions and barriers to virtual care are different. Moving forward, we need to pay attention to both staff and patient experiences with virtual care since this will have major implications for long-term adoption into clinical practice.

Interventions to Promote Safety Culture in Cancer Care: A Systematic Review.

OBJECTIVES: There is limited guidance on how to effectively promote safety culture in health care settings. We performed a systematic review to identify interventions to promote safety culture, specifically in oncology settings. METHODS: Medical Subject Headings and text words for "safety culture" and "cancer care" were combined to conduct structured searches of MEDLINE, EMBASE, CDSR, CINAHL, Cochrane CENTRAL, PsycINFO, Scopus, and Web of Science for peer-reviewed articles published from 1999 to 2021. To be included, articles had to evaluate a safety culture intervention in an oncology setting using a randomized or nonrandomized, pre-post (controlled or uncontrolled), interrupted time series, or repeated-measures study design. The review followed PRISMA guidelines; quality of included citations was assessed using the ROBINS-I risk of bias tool. RESULTS: Eighteen articles meeting the inclusion criteria were retained, reporting on interventions in radiation (14 of 18), medical (3 of 18), or general oncology (1 of 18) settings. Articles most commonly addressed incident learning systems (7 of 18), lean initiatives (4 of 18), or quality improvement programs (3 of 18). Although 72% of studies reported improvement in safety culture, there was substantial heterogeneity in the evaluation approach; rates of reporting of adverse events (9 of 18) or Agency for Healthcare Research and Quality Safety Culture survey results (9 of 18) were the most commonly used metrics. Most of the studies had moderate (28%) or severe (67%) risk of bias. CONCLUSIONS: Despite a growing evidence base describing interventions to promote safety culture in cancer care, definitive recommendations were difficult to make because of heterogeneity in study designs and outcomes. Implementation of incident learning systems seems to hold most promise.

Indolent lymphoma care delivery and outcomes during the COVID-19 pandemic in Ontario, Canada.

The treatment pattern and outcomes in patients with indolent B-cell lymphoma treated during the coronavirus disease 2019 (COVID-19) pandemic period compared to the prepandemic period are unclear. This was a retrospective population-based study using administrative databases in Ontario, Canada (follow-up to 31 March 2022). The primary outcome was treatment pattern; secondary outcomes were death, toxicities, healthcare utilization (emergency department [ED] visit, hospitalization) and SARS-CoV-2 outcomes. Adjusted hazard ratios (aHR) from Cox proportional hazards models were used to estimate associations. We identified 4143 patients (1079 pandemic, 3064 prepandemic), with a median age of 69 years. In both time periods, bendamustine (B) + rituximab (BR) was the most frequently prescribed regimen. During the pandemic, fewer patients received R maintenance or completed the full 2-year course (aHR 0.81, 95% CI 0.71-0.92, p = 0.001). Patients treated during the pandemic had less healthcare utilization (ED visit aHR 0.77, 95% CI 0.68, 0.88, p < 0.0001; hospitalization aHR 0.81, 95% CI 0.70-0.94, p = 0.0067) and complications (infection aHR 0.69, 95% CI 0.57-0.82, p < 0.0001; febrile neutropenia aHR 0.66, 95% CI 0.47-0.94, p = 0.020), with no difference in death. Independent of vaccination, active rituximab use was associated with a higher risk of COVID-19 complications. Despite similar front-line regimen use, healthcare utilization and admissions for infection were less in the pandemic cohort.

Machine Learning-Based Early Warning Systems for Acute Care Utilization During Systemic Therapy for Cancer.

BACKGROUND: Emergency department visits and hospitalizations frequently occur during systemic therapy for cancer. We developed and evaluated a longitudinal warning system for acute care use. METHODS: Using a retrospective population-based cohort of patients who started intravenous systemic therapy for nonhematologic cancers between July 1, 2014, and June 30, 2020, we randomly separated patients into cohorts for model training, hyperparameter tuning and model selection, and system testing. Predictive features included static features, such as demographics, cancer type, and treatment regimens, and dynamic features, such as patient-reported symptoms and laboratory values. The longitudinal warning system predicted the probability of acute care utilization within 30 days after each treatment session. Machine learning systems were developed in the training and tuning cohorts and evaluated in the testing cohort. Sensitivity analyses considered feature importance, other acute care endpoints, and performance within subgroups. RESULTS: The cohort included 105,129 patients who received 1,216,385 treatment sessions. Acute care followed 182,444 (15.0%) treatments within 30 days. The ensemble model achieved an area under the receiver operating characteristic curve of 0.742 (95% CI, 0.739-0.745) and was well calibrated in the test cohort. Important predictive features included prior acute care use, treatment regimen, and laboratory tests. If the system was set to alarm approximately once every 15 treatments, 25.5% of acute care events would be preceded by an alarm, and 47.4% of patients would experience acute care after an alarm. The system underestimated risk for some treatment regimens and potentially underserved populations such as females and non-English speakers. CONCLUSIONS: Machine learning warning systems can detect patients at risk for acute care utilization, which can aid in preventive intervention and facilitate tailored treatment. Future research should address potential biases and prospectively evaluate impact after system deployment.

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.

Daily physical activity monitoring in older adults with metastatic prostate cancer on active treatment: Feasibility and associations with toxicity.

INTRODUCTION: Physical activity may be associated with cancer treatment toxicity, but generalizability to geriatric oncology is unclear. As many older adults have low levels of physical activity and technology use, this area needs further exploration. We evaluated the feasibility of daily step count monitoring and the association between step counts and treatment-emergent symptoms. MATERIALS AND METHODS: Adults aged 65+ starting treatment (chemotherapy, enzalutamide/abiraterone, or radium-223) for metastatic prostate cancer were enrolled in a prospective cohort study. Participants reported step counts (measured via smartphone) and symptoms (Edmonton Symptom Assessment Scale) daily for one treatment cycle (i.e., 3-4 weeks). Embedded semi-structured interviews were performed upon completion of the study. The feasibility of daily monitoring was evaluated with descriptive statistics and thematic analysis. The predictive validity of a decline in daily steps (compared to pre-treatment baseline) for the emergence of symptoms was examined using sensitivity and positive predictive value (PPV). Associations between a 15% decline in steps and the emergence of moderate (4-6/10) to severe (7-10/10) symptoms and pain in the next 24 h were assessed using logistic regression. RESULTS: Of 90 participants, 47 engaged in step count monitoring (median age = 75, range = 65-88; 52.2% participation rate). Daily physical activity monitoring was found to be feasible (94% retention rate; 90.5% median response rate) with multiple patient-reported benefits including increased self-awareness and motivation to engage in physical activity. During the first treatment cycle, instances of a 15% decline in steps were common (n = 37, 78.7%), as was the emergence of moderate to severe symptoms overall (n = 40, 85.1%) and pain (n = 26, 55.3%). The predictive validity of a 15% decline in steps on the emergence of moderate to severe symptoms was good (sensitivity = 81.8%, 95% confidence interval [CI] = 68.7-95.0; PPV = 73.0%, 95% CI = 58.7-87.3), although the PPV for pain was poor (sensitivity = 77.8%, 95% CI = 58.6-97.0; PPV = 37.8%, 95% CI = 22.2-53.5). In the regression models, changes in daily physical activity were not associated with symptoms or pain. DISCUSSION: Changes in physical activity had modest ability to predict moderate to severe symptoms overall. Although participation was suboptimal, daily activity monitoring in older adults with cancer appears feasible and may have other uses such as improving physical activity levels. Further studies are warranted.

A Web-Based Cancer Self-Management Program (I-Can Manage) Targeting Treatment Toxicities and Health Behaviors: Human-Centered Co-design Approach and Cognitive Think-Aloud Usability Testing.

BACKGROUND: Patients with cancer require adequate preparation in self-management of treatment toxicities to reduce morbidity that can be achieved through well-designed digital technologies that are developed in co-design with patients and end users. OBJECTIVE: We undertook a user-centered co-design process in partnership with patients and other knowledge end users to develop and iteratively test an evidence-based and theoretically informed web-based cancer self-management program (I-Can Manage). The specific study aims addressed in 2 phases were to (1) identify from the perspective of patients with cancer and clinicians the desired content, features, and functionalities for an online self-management education and support (SMES) program to enable patient self-management of treatment toxicities (phase 1); (2) develop the SMES prototype based on human-centered, health literate design principles and co-design processes; and (3) evaluate usability of the I-Can Manage prototype through user-centered testing (phase 2). METHODS: We developed the I-Can Manage program using multiperspective data sources and based on humanistic and co-design principles with end users engaged through 5 phases of development. We recruited adult patients with lung, colorectal, and lymphoma cancer receiving systemic treatments from ambulatory clinics in 2 regional cancer programs for the qualitative inquiry phase. The design of the program was informed by data from qualitative interviews and focus groups, persona and journey mapping, theoretical underpinnings of social cognitive learning theory, and formalized usability testing using a cognitive think-aloud process and user satisfaction survey. A co-design team comprising key stakeholders (human design experts, patients/caregiver, clinicians, knowledge end users, and e-learning and digital design experts) was involved in the developmental process. We used a cognitive think-aloud process to test usability and participants completed the Post-Study System Usability Questionnaire (PSSUQ). RESULTS: In the initial qualitative inquiry phase, 16 patients participated in interviews and 19 clinicians participated in interviews or focus groups and 12 key stakeholders participated in a persona journey mapping workshop to inform development of the program prototype. The I-Can Manage program integrates evidence-based information and strategies for the self-management of treatment toxicities and health-promoting behaviors in 6 e-learning modules (lay termed "chapters"), starting with an orientation to self-management. Behavioral exercises, patient written and video stories, downloadable learning resources, and online completion of goals and action plans were integrated across chapters. Patient participants (n=5) with different cancers, gender, and age worked through the program in the human factors laboratory using a cognitive think-aloud process and all key stakeholders reviewed each chapter of the program and approved revisions. Results of the PSSUQ (mean total score: 3.75) completed following the cognitive think-aloud process (n=5) suggest patient satisfaction with the usability of I-Can Manage. CONCLUSIONS: The I-Can Manage program has the potential for activating patients in self-management of cancer and treatment toxicities but requires testing in a larger randomized controlled trial.

Drivers of Emergency Department Use Among Oncology Patients in the Era of Novel Cancer Therapeutics: A Systematic Review.

BACKGROUND: Patients diagnosed with cancer are frequent users of the emergency department (ED). While many visits are unavoidable, a significant portion may be potentially preventable ED visits (PPEDs). Cancer treatments have greatly advanced, whereby patients may present with unique toxicities from targeted therapies and are often living longer with advanced disease. Prior work focused on patients undergoing cytotoxic chemotherapy, and often excluded those on supportive care alone. Other contributors to ED visits in oncology, such as patient-level variables, are less well-established. Finally, prior studies focused on ED diagnoses to describe trends and did not evaluate PPEDs. An updated systematic review was completed to focus on PPEDs, novel cancer therapies, and patient-level variables, including those on supportive care alone. METHODS: Three online databases were used. Included publications were in English, from 2012-2022, with sample sizes of ≥50, and reported predictors of ED presentation or ED diagnoses in oncology. RESULTS: 45 studies were included. Six studies highlighted PPEDs with variable definitions. Common reasons for ED visits included pain (66%) or chemotherapy toxicities (69.1%). PPEDs were most frequent amongst breast cancer patients (13.4%) or patients receiving cytotoxic chemotherapy (20%). Three manuscripts included immunotherapy agents, and only one focused on end-of-life patients. CONCLUSION: This updated systematic review highlights variability in oncology ED visits during the last decade. There is limited work on the concept of PPEDs, patient-level variables and patients on supportive care alone. Overall, pain and chemotherapy toxicities remain key drivers of ED visits in cancer patients. Further work is needed in this realm.

Symptom screening with Targeted Early Palliative care (STEP) versus usual care for patients with advanced cancer: a mixed methods study.

PURPOSE: Although early palliative care is recommended, resource limitations prevent its routine implementation. We report on the preliminary findings of a mixed methods study involving a randomized controlled trial (RCT) of Symptom screening with Targeted Early Palliative care (STEP) and qualitative interviews. METHODS: Adults with advanced solid tumors and an oncologist-estimated prognosis of 6-36 months were randomized to STEP or symptom screening alone. STEP involved symptom screening at each outpatient oncology visit; moderate to severe scores triggered an email to a palliative care nurse, who offered referral to in-person outpatient palliative care. Patient-reported outcomes of quality of life (FACT-G7; primary outcome), depression (PHQ-9), symptom control (ESAS-r-CS), and satisfaction with care (FAMCARE P-16) were measured at baseline and 2, 4, and 6 months. Semi-structured interviews were conducted with a subset of participants. RESULTS: From Aug/2019 to Mar/2020 (trial halted due to COVID-19 pandemic), 69 participants were randomized to STEP (n = 33) or usual care (n = 36). At 6 months, 45% of STEP arm patients and 17% of screening alone participants had received palliative care (p = 0.009). Nonsignificant differences for all outcomes favored STEP: difference in change scores for FACT-G7 = 1.67 (95% CI: -1.43, 4.77); ESAS-r-CS = -5.51 (-14.29, 3.27); FAMCARE P-16 = 4.10 (-0.31, 8.51); PHQ-9 = -2.41 (-5.02, 0.20). Sixteen patients completed qualitative interviews, describing symptom screening as helpful to initiate communication; triggered referral as initially jarring but ultimately beneficial; and referral to palliative care as timely. CONCLUSION: Despite lack of power for this halted trial, preliminary results favored STEP and qualitative results demonstrated acceptability. Findings will inform an RCT of combined in-person and virtual STEP.

Association between the COVID-19 pandemic and first cancer treatment modality: a population-based cohort study.

BACKGROUND: Physicians were directed to prioritize using nonsurgical cancer treatment at the beginning of the COVID-19 pandemic. We sought to quantify the impact of this policy on the modality of first cancer treatment (surgery, chemotherapy, radiotherapy or no treatment). METHODS: In this population-based study using Ontario data from linked administrative databases, we identified adults diagnosed with cancer from January 2016 to November 2020 and their first cancer treatment received within 1 year postdiagnosis. Segmented Poisson regressions were applied to each modality to estimate the change in mean 1-year recipient volume per thousand patients (rate) at the start of the pandemic (the week of Mar. 15, 2020) and change in the weekly trend in rate during the pandemic (Mar. 15, 2020, to Nov. 7, 2020) relative to before the pandemic (Jan. 3, 2016, to Mar. 14, 2020). RESULTS: We included 321 535 people diagnosed with cancer. During the first week of the COVID-19 pandemic, the mean rate of receiving upfront surgery over the next year declined by 9% (rate ratio 0.91, 95% confidence interval [CI] 0.88-0.95), and chemotherapy and radiotherapy rates rose by 30% (rate ratio 1.30, 95% CI 1.23-1.36) and 13% (rate ratio 1.13, 95% CI 1.07-1.19), respectively. Subsequently, the 1-year rate of upfront surgery increased at 0.4% for each week (rate ratio 1.004, 95% CI 1.002-1.006), and chemotherapy and radiotherapy rates decreased by 0.9% (rate ratio 0.991, 95% CI 0.989-0.994) and 0.4% (rate ratio 0.996, 95% CI 0.994-0.998), respectively, per week. Rates of each modality resumed to prepandemic levels at 24-31 weeks into the pandemic. INTERPRETATION: An immediate and sustained increase in use of nonsurgical therapy as the first cancer treatment occurred during the first 8 months of the COVID-19 pandemic in Ontario. Further research is needed to understand the consequences.

Implementing Innovation: Informatics-Based Technologies to Improve Care Delivery and Clinical Research.

Improving technology has promised to improved health care delivery and the lives of patients. The realized benefits of technology, however, are delayed or less than anticipated. Three recent technology initiatives are reviewed: the Clinical Trials Rapid Activation Consortium (CTRAC), minimal Common Oncology Data Elements (mCODE), and electronic Patient-Reported Outcomes. Each initiative is at a different stage of maturity but promises to improve the delivery of cancer care. CTRAC is an ambitious initiative funded by the National Cancer Institute (NCI) to develop processes across multiple NCI-supported cancer centers to facilitate the development of centralized electronic health record (EHR) treatment plans. Facilitating interoperability of treatment regimens has the potential to improve sharing between centers and decrease the time to begin clinical trials. The mCODE initiative began in 2019 and is currently Standard for Trial Use version 2. This data standard provides an abstraction layer on top of EHR data and has been implemented across more than 60 organizations. Patient-reported outcomes have been shown to improve patient care in numerous studies. Best practices for how to leverage these in an oncology practice continue to evolve. These three examples show how innovative has diffused into practice and evolved cancer care delivery and highlight a movement toward patient-centered data and interoperability.

Early mortality in patients with cancer treated with immune checkpoint inhibitors in routine practice.

BACKGROUND: We sought to estimate the proportion of patients with cancer treated with immune checkpoint inhibitors (ICI) who die soon after starting ICI in the real world and examine factors associated with early mortality (EM). METHODS: We conducted a retrospective cohort study using linked health administrative data from Ontario, Canada. EM was defined as death from any cause within 60 days of ICI initiation. Patients with melanoma, lung, bladder, head and neck, or kidney cancer treated with ICI between 2012 and 2020 were included. RESULTS: A total of 7126 patients treated with ICI were evaluated. Fifteen percent (1075 of 7126) died within 60 days of initiating ICI. The highest mortality was observed in patients with bladder and head and neck tumors (approximately 21% each). In multivariable analysis, previous hospital admission or emergency department visit, prior chemotherapy or radiation therapy, stage 4 disease at diagnosis, lower hemoglobin, higher white blood cell count, and higher symptom burden were associated with higher risk of EM. Conversely, patients with lung and kidney cancer (compared with melanoma), lower neutrophil to lymphocytes ratio, and with higher body mass index were less likely to die within 60 days post ICI initiation. In a sensitivity analysis, 30-day and 90-day mortality were 7% (519 of 7126) and 22% (1582 of 7126), respectively, with comparable clinical factors associated with EM identified. CONCLUSIONS: EM is common among patients treated with ICI in the real-world setting and is associated with several patient and tumor characteristics. Development of a validated tool to predict EM may facilitate better patient selection for treatment with ICI in routine practice.

Implementation of medication reconciliation in outpatient cancer care.

BACKGROUND: Medication reconciliation (MedRec) is a process where providers work with patients to document and communicate comprehensive medication information by creating a complete medication list (best possible medication history (BPMH)) then reconciling it against what patient is actually taking to identify potential issues such as drug-drug interactions. We undertook an environmental scan of current MedRec practices in outpatient cancer care to inform a quality improvement project at our centre with the aim of 30% of patients having a BPMH or MedRec within 30 days of initiating treatment with systemic therapy. METHODS: We conducted semi-structured interviews with key stakeholders from 21 cancer centres across Canada, probing on current policies, and barriers and facilitators to MedRec. Guided by the findings of the scan, we then undertook a quality improvement project at our cancer centre, comprising six iterative improvement cycles. RESULTS: Most institutions interviewed had a process in place for collecting a BPMH (81%) and targeted patients initiating systemic therapy (59%); however, considerable practice variation was noted and completion of full MedRec was uncommon. Lack of resources, high patient volumes, lack of a common medical record spanning institutions and settings which limits access to medication records from external institutions and community pharmacies were identified as significant barriers. Despite navigating challenges related to the COVID-19 pandemic, we achieved 26.6% of eligible patients with a documented BPMH. However, uptake of full MedRec remained low whereby 4.7% of patients had a documented MedRec. CONCLUSIONS: Realising improvements to completion of MedRec in outpatient cancer care is possible but takes considerable time and iteration as the process is complex. Resource allocation and information sharing remain major barriers which need to be addressed in order to observe meaningful improvements in MedRec.

Early survival for patients newly diagnosed with cancer during COVID-19 in Ontario, Canada: A population-based cohort study.

BACKGROUND: Little is known about the association between the COVID-19 pandemic and early survival among newly diagnosed cancer patients. METHODS: This retrospective population-based cohort study used linked administrative datasets from Ontario, Canada. Adults (≥18 years) who received a cancer diagnosis between March 15 and December 31, 2020, were included in a pandemic cohort, while those diagnosed during the same dates in 2018/2019 were included in a pre-pandemic cohort. All patients were followed for one full year after the date of diagnosis. Cox proportional hazards regression models were used to assess survival in relation to the pandemic, patient characteristics at diagnosis, and the modality of first cancer treatment as a time-varying covariate. Interaction terms were explored to measure the pandemic association with survival for each cancer type. RESULTS: Among 179,746 patients, 53,387 (29.7%) were in the pandemic cohort and 37,741 (21.0%) died over the first post-diagnosis year. No association between the pandemic and survival was found when adjusting for patient characteristics at diagnosis (HR 0.99 [95% CI 0.96-1.01]), while marginally better survival was found for the pandemic cohort when the modality of treatment was additionally considered (HR 0.97 [95% CI 0.95-0.99]). When examining each cancer type, only a new melanoma diagnosis was associated with a worse survival in the pandemic cohort (HR 1.25 [95% CI 1.05-1.49]). CONCLUSIONS: Among patients able to receive a cancer diagnosis during the pandemic, one-year overall survival was not different than those diagnosed in the previous 2 years. This study highlights the complex nature of the COVID-19 pandemic impact on cancer care.

Promoting Self-management and Patient Activation Through eHealth: Protocol for a Systematic Literature Review and Meta-analysis.

BACKGROUND: Major advances in different cancer treatment modalities have been made, and people are now living longer with cancer. However, patients with cancer experience a range of physical and psychological symptoms during and beyond cancer treatment. New models of care are needed to combat this rising challenge. A growing body of evidence supports the effectiveness of eHealth interventions in the delivery of supportive care to people living with the complexities of chronic health conditions. However, reviews on the effects of eHealth interventions are scarce in the field of cancer-supportive care, particularly for interventions with the aim of empowering patients to manage cancer treatment-related symptoms. For this reason, this protocol has been developed to guide a systematic review and meta-analysis to assess the effectiveness of eHealth interventions for supporting patients with cancer in managing cancer-related symptoms. OBJECTIVE: This systematic review with meta-analysis is conducted with the aim of identifying eHealth-based self-management intervention studies for adult patients with cancer and evaluating the efficacy of eHealth-based self-management tools and platforms in order to synthesize the empirical evidence on self-management and patient activation through eHealth. METHODS: A systematic review with meta-analysis and methodological critique of randomized controlled trials is conducted following Cochrane Collaboration methods. Multiple data sources are used to identify all potential research sources for inclusion in the systematic review: (1) electronic databases such as MEDLINE, (2) forward reference searching, and (3) gray literature. The PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for conducting the review were followed. The PICOS (Population, Interventions, Comparators, Outcomes, and Study Design) framework is used to identify relevant studies. RESULTS: The literature search yielded 10,202 publications. The title and abstract screening were completed in May 2022. Data will be summarized, and if possible, meta-analyses will be performed. It is expected to finalize this review by Winter 2023. CONCLUSIONS: The results of this systematic review will provide the latest data on leveraging eHealth interventions and offering effective and sustainable eHealth care, both of which have the potential to improve quality and efficiency in cancer-related symptoms. TRIAL REGISTRATION: PROSPERO 325582; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=325582. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/38758.