Feasibility and Effectiveness of Self-Management Education and Coaching on Patient Activation for Managing Cancer Treatment Toxicities.

BACKGROUND: Poorly managed cancer treatment toxicities negatively impact quality of life, but little research has examined patient activation in self-management (SM) early in cancer treatment. METHODS: We undertook a pilot randomized trial to evaluate the feasibility, acceptability, and preliminary effectiveness of the SMARTCare (Self-Management and Activation to Reduce Treatment Toxicities) intervention. This intervention included an online SM education program (I-Can Manage) plus 5 sessions of telephone cancer coaching in patients initiating systemic therapy for lymphoma or colorectal or lung cancer at 3 centers in Ontario, Canada, relative to a usual care control group. Patient-reported outcomes included patient activation (Patient Activation Measure [PAM]), symptom or emotional distress, self-efficacy, and quality of life. Descriptive statistics and Wilcoxon rank-sum tests were used to examine changes over time (baseline and at 2, 4, and 6 months) within and between groups. We used general estimating equations to compare outcomes between groups over time. The intervention group completed an acceptability survey and qualitative interviews. RESULTS: Of 90 patients approached, 62 (68.9%) were enrolled. Mean age of the sample was 60.5 years. Most patients were married (77.1%), were university educated (71%), had colorectal cancer (41.9%) or lymphoma (42.0%), and had stage III or IV disease (75.8%). Attrition was higher in the intervention group than among control subjects (36.7% vs 25%, respectively). Adherence to I-Can Manage was low; 30% of intervention patients completed all 5 coaching calls, but 87% completed ≥1. Both the continuous PAM total score (P<.001) and categorical PAM levels (3/4 vs 1/2) (P=.002) were significantly improved in the intervention group. CONCLUSIONS: SM education and coaching early during cancer treatment may improve patient activation, but a larger trial is needed. CLINICALTRIALS: gov Identifier: NCT03849950.

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.

Considerations for Virtual Care Following the Pandemic.

The pandemic has served as an impetus for rapid uptake of virtual care into clinical practice, creating new patient and clinician needs and a willingness to adopt new technologies. It is obvious that healthcare will not return to pre-pandemic levels of in-person care and that patients expect virtual care to remain an option. However, the underlying structural and behavioural barriers related to equity, access, infrastructure, provider licensing and remuneration structures that limited pre-pandemic use of virtual care still persist. Herein, we provide recommendations and tangible next steps to sustain virtual care moving forward.

Impact of the early phase of the COVID pandemic on cancer treatment delivery and the quality of cancer care: a scoping review and conceptual model.

BACKGROUND: The disruption of health services due to coronavirus disease (COVID) is expected to dramatically alter cancer care; however, the implications for care quality and outcomes remain poorly understood. OBJECTIVE: 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 (from 1 January 2019 to 28 October 2020), utilizing search terms grouped by the 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 (ST) 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%; ST: 55.8% and 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 was the quality domains found to be the 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 the quality of care and patient outcomes.

Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol.

BACKGROUND: Population-based studies suggest that emergency department visits and hospitalizations are common among patients receiving chemotherapy and that rates in routine practice are higher than expected from clinical trials. Chemotherapy-related toxicities are often predictable and, consequently, acute care visits may be preventable with adequate treatment planning and support between visits to the cancer centre. We will evaluate the impact of proactive telephone-based toxicity management on emergency department visits and hospitalizations in women with early stage breast cancer receiving chemotherapy. METHODS: In this pragmatic covariate constraint-based cluster randomized trial, 20 centres in Ontario, Canada are randomly allocated to either proactive telephone toxicity management (intervention) or routine care (control). The primary outcome is the cluster-level mean number of ED + H visits per patient evaluated using Ontario administrative healthcare data. Participants are all patients with early stage (I-III) breast cancer commencing adjuvant or neo-adjuvant chemotherapy at participating institutions during the intervention period. At least 25 patients at each centre participate in a patient reported outcomes sub-study involving the collection of standardized questionnaires to measure: severity of treatment toxicities, self-care, self-efficacy, quality of life, and coordination of care. Patients participating in the patient reported outcomes (PRO) sub-study are asked to provide written consent to link their PRO data to administrative data. Unit costs will be applied to each per person resource utilized, and a total cost per population and patient will be generated. An incremental cost-effectiveness analysis will be undertaken to compare the incremental costs and outcomes between the intervention and control groups from the health system perspective. DISCUSSION: This study evaluates the effectiveness of a proactive toxicity management intervention in a routine care setting. The use of administrative healthcare data to evaluate the primary outcome enables an evaluation in a real world setting and at a much larger scale than previous studies. TRIAL REGISTRATION: Clinicaltrials.gov , NCT02485678. Registered 30 June 2015.

Hospitalisations and emergency department visits in cancer patients receiving systemic therapy: Systematic review and meta-analysis.

Emergency department visits and hospitalisations (ED+H) during systemic therapy are undesirable for both patients and the health system. We undertook a systematic literature review and meta-analysis to evaluate the frequency of unplanned all-cause and treatment-related ED+H among adults receiving adjuvant or palliative-intent systemic therapy for all cancers. Randomised controlled trials (RCT) and observational studies (OS) reporting ED+H were identified from Medline and EMBASE from inception to June 2016. Quality was assessed using modified STROBE, CONSORT or PRISMA guidelines, depending on study type. A total of 112 OS (308,662 patients) and 26 RCTs (16,081 patients) met inclusion criteria. Most articles focused on palliative treatment (59%) delivered as first-line, in breast, lung and colorectal cancers. Only 20 articles reported ED frequency. Treatment-related and all-cause hospitalisations were more common in routine practice than in RCTs (29% vs. 16% and 42% vs. 28% respectively); frequency varied by treatment intent and tumour site. Methodological issues were common, particularly poor definition of the at-risk period. Hospitalisations are common, especially in unselected populations, but few articles report this and do so poorly. Routine, standardised reporting of ED+H during chemotherapy should be included in RCT reports and evaluated in routine care following adoption of new treatments.

User-Centered Design of a Web-Based Tool to Support Management of Chemotherapy-Related Toxicities in Cancer Patients.

BACKGROUND: Cancer patients receiving chemotherapy have high symptom needs that can negatively impact quality of life and result in high rates of unplanned acute care visits. Remote monitoring tools may improve symptom management in this patient population. OBJECTIVE: This study aimed to design a prototype tool to facilitate remote management of chemotherapy-related toxicities. METHODS: User needs were assessed using a participatory, user-centered design methodology that included field observation, interviews, and focus groups, and then analyzed using affinity diagramming. Participants included oncology patients, caregivers, and health care providers (HCPs) including medical oncologists, oncology nurses, primary care physicians, and pharmacists in Ontario, Canada. Overarching themes informed development of a Web-based prototype, which was further refined over 2 rounds of usability testing with end users. RESULTS: Overarching themes were derived from needs assessments, which included 14 patients, 1 caregiver, and 12 HCPs. Themes common to both patients and HCPs included gaps and barriers in current systems, need for decision aids, improved communication and options in care delivery, secure access to credible and timely information, and integration into existing systems. In addition, patients identified missed opportunities, care not meeting their needs, feeling overwhelmed and anxious, and wanting to be more empowered. HCPs identified accountability for patient management as an issue. These themes informed development of a Web-based prototype (bridges), which included toxicity tracking, self-management advice, and HCP communication functionalities. Usability testing with 11 patients and 11 HCPs was generally positive; however, identified challenges included tool integration into existing workflows, need for standardized toxicity self-management advice, issues of privacy and consent, and patient-tailored information. CONCLUSIONS: Web-based tools integrating just-in-time self-management advice and HCP support into routine care may address gaps in systems for managing chemotherapy-related toxicities. Attention to the integration of new electronic tools into self-care by patients and practice was a strong theme for both patients and HCP participants and is a key issue that needs to be addressed for wide-scale adoption.

Establishing achievable benchmarks for quality improvement in systemic therapy for early-stage breast cancer.

BACKGROUND: Setting realistic targets for performance is a consistent challenge in quality improvement. In the current study, the authors used administrative data to define achievable targets for a panel of 15 previously developed quality indicators (QIs) focusing on systemic therapy in patients with early-stage breast cancer. METHODS: Deterministically linked administrative databases were used to identify patients with TNM stage I to stage III breast cancer who were diagnosed between 2006 and 2010 in Ontario, Canada. For each individual indicator, data-driven empirical benchmarks were calculated using the pared-mean benchmark approach. Variation in institution-level performance for each indicator was examined through the construction of funnel plots. RESULTS: A total of 28,303 patients with early-stage breast cancer were identified, 43% of whom received adjuvant chemotherapy. For the 9 QIs for which receiving the service or outcome was desirable (ie, consultation with a medical oncologist), the benchmark varied from 40.9% to 100%. For the 6 indicators for which not receiving the service or outcome was desirable (ie, incidence of febrile neutropenia), the benchmark varied from 0% to 49.0%. There was substantial variation noted with regard to the number of institutions meeting the target and the amount of interinstitution variation between the QIs. Top performing institutions varied by indicator, with no individual institution meeting the benchmark for all indicators. For the majority of indicators, institution size was not found to be correlated with performance. CONCLUSIONS: Data-derived benchmarking can be used to facilitate quality improvement by identifying areas of both good as well as suboptimal performance while defining an achievable target for which to strive. Cancer 2017;123:3772-3780. © 2017 American Cancer Society.

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.

The Impact of the Pandemic on the Quality of Colorectal and Anal Cancer Care, and 2-Year Clinical Outcomes.

We undertook a retrospective study to compare the quality of care delivered to a cohort of newly diagnosed adults with colon, rectal or anal cancer during the early phase of COVID-19 (02/20-12/20) relative to the same period in the year prior (the comparator cohort), and examine the impact of the pandemic on 2-year disease progression and all-cause mortality. We observed poorer performance on a number of quality measures, such as approximately three times as many patients in the COVID-19 cohort experienced 30-day post-surgical readmission (10.5% vs. 3.6%; SD:0.27). Despite these differences, we observed no statistically significant adjusted associations between COVID-19 and time to either all-cause mortality (HR: 0.88, 95% CI: 0.61-1.27, p = 0.50) or disease progression (HR: 1.16, 95% CI: 0.82-1.64, p = 0.41). However, there was a substantial reduction in new patient consults during the early phase of COVID-19 (12.2% decrease), which appeared to disproportionally impact patients who traditionally experience sociodemographic disparities in access to care, given that the COVID-19 cohort skewed younger and there were fewer patients from neighborhoods with the highest Housing and Dwelling, ands Age and Labour Force marginalization quintiles. Future work is needed to understand the more downstream effects of COVID-19 related changes on cancer care to inform planning for future disruptions in care.

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.

Survivorship care for patients curatively treated for Hodgkin's and non-Hodgkin's lymphoma: a scoping review.

PURPOSE: We undertook a scoping review of the literature to synthesize what is known about lymphoma survivorship and develop a comprehensive set of lymphoma-specific survivorship recommendations. METHODS: We searched the peer-reviewed literature from January 1995 to April 2022, focused on topics relevant to survivorship care in patients ≥ 18 years of age, treated curatively for non-Hodgkin's and Hodgkin's lymphoma, and in remission for at least 2 years. RESULTS: We retained 92 articles; themes included late effects of treatment (53.3%, 49/92), particularly fatigue and sleep disturbances, and fertility, as well as psychosocial considerations of survivors (27.2%; 25/92), screening for secondary malignancies (22.8%; 21/92), outcomes of interventions to improve survivorship care (10.9%; 10/92), and best practices and elements for survivorship plans (8.7%; 8/92). While there were published guidelines for screening for recurrence and secondary malignancies, despite the considerable number of articles on the psychosocial aspects of survivorship care, there remains limited guidance on screening frequency and management strategies for anxiety and depression, sleep disturbances, and treatment-related fatigue within the lymphoma population. CONCLUSION: We have developed a comprehensive set of lymphoma-survivorship recommendations; however, work is needed to adapt them to local healthcare contexts. IMPLICATIONS FOR SURVIVORS: While there is a focus in the literature on the long-term psychosocial impacts of cancer and its treatment on lymphoma survivors, there remains no concrete recommendations on effective screening and management of detriments to quality of life such as anxiety, depression, fatigue, and distress, and availability of local resources vary widely.

Staff Experiences With Remote Work in a Comprehensive Cancer Center During the COVID-19 Pandemic and Recommendations for Long-Term Adoption.

BACKGROUND: The COVID-19 pandemic led to the rapid implementation of remote work, but few studies have examined the impact. We evaluated clinical staff experience with working remotely at a large, urban comprehensive cancer center in Toronto, Canada. METHODS: An electronic survey was disseminated between June 2021, and August 2021, via e-mail to staff who had completed at least some remote work during the COVID-19 pandemic. Factors associated with a negative experience were examined with binary logistic regression. Barriers were derived from a thematic analysis of open-text fields. RESULTS: Most respondents (N = 333; response rate, 33.2%) were age 40-69 years (46.2%), female (61.3%), and physicians (24.6%). Although the majority of respondents wished to continue remote work (85.6%), relative to administrative staff (admin), physicians (odds ratio [OR], 16.6; 95% CI, 1.45 to 190.14) and pharmacists (OR, 12.6; 95% CI, 1.0 to 158.9) were more likely to want to return on-site. Physicians were approximately eight times more likely to report dissatisfaction with remote work (OR, 8.4; 95% CI, 1.4 to 51.6) and 24 times more likely to report that remote work negatively affected efficiency (OR, 24.0; 95% CI, 2.7 to 213.0); nurses were approximately seven times more likely to report the need for additional resources (OR, 6.5; 95% CI, 1.71 to 24.48) and/or training (OR, 7.02; 95% CI, 1.78 to 27.62). The most common barriers were the absence of fair processes for allocation of remote work, poor integration of digital applications and connectivity, and poor role clarity. CONCLUSION: Although overall satisfaction with working remotely was high, work is needed to overcome barriers to implementation of remote and hybrid work models in the health care setting.

Factors associated with timely COVID-19 vaccination in a population-based cohort of patients with cancer.

BACKGROUND: In many jurisdictions, cancer patients were prioritized for COVID-19 vaccination because of increased risk of infection and death. To understand sociodemographic disparities that affected timely receipt of COVID-19 vaccination among cancer patients, we undertook a population-based study in Ontario, Canada. METHODS: Patients older than 18 years and diagnosed with cancer January 2010 to September 2020 were identified using administrative data; vaccination administration was captured between approval (December 2020) up to February 2022. Factors associated with time to vaccination were evaluated using multivariable Cox proportional hazards regression. RESULTS: The cohort consisted of 356 535 patients, the majority of whom had solid tumor cancers (85.9%) and were not on active treatment (74.1%); 86.8% had received at least 2 doses. The rate of vaccination was 25% lower in recent (hazard ratio [HR] = 0.74, 95% confidence interval [CI] = 0.72 to 0.76) and nonrecent immigrants (HR = 0.80, 95% CI = 0.79 to 0.81). A greater proportion of unvaccinated patients were from neighborhoods with a high concentration of new immigrants or self-reported members of racialized groups (26.0% vs 21.3%, standardized difference = 0.111, P < .001), residential instability (27.1% vs 23.0%, standardized difference = 0.094, P < .001), or material deprivation (22.1% vs 16.8%, standardized difference = 0.134, P < .001) and low socioeconomic status (20.9% vs 16.0%, standardized difference = 0.041, P < .001). The rate of vaccination was 20% lower in patients from neighborhoods with the lowest socioeconomic status (HR = 0.82, 95% CI = 0.81 to 0.84) and highest material deprivation (HR = 0.80, 95% CI = 0.78 to 0.81) relative to those in more advantaged neighborhoods. CONCLUSIONS: Despite funding of vaccines and prioritization of high-risk populations, marginalized patients were less likely to be vaccinated. Differences are likely due to the interplay between systemic barriers to access and cultural or social influences affecting uptake.

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.

Impact of a Training Program on Oncology Nurses' Confidence in the Provision of Self-Management Support and 5As Behavioral Counseling Skills.

BACKGROUND: Cancer patients and their families play a central role in the self-management of the medical, emotional, and lifestyle consequences of cancer. Nurses with training in self-management support can enable cancer patients to better manage the effects of cancer and treatment. METHODS: As part of a randomized controlled trial, we developed a training program to build nurses' confidence in the provision of self-management support (SMS). The SMS skills taught were adapted from the Stanford Peer Support training programs and embedded within the 5As (Assess, Advise, Agree, Assist, and Arrange) behavioral counseling process. We evaluated the impact of the training program on oncology nurses' and coaches' confidence using a Student's t-test for paired samples in a nonrandomized, one-group pre/postsurvey. RESULTS: Participants were experienced oncology nurses from three participating cancer centers. A two-tailed Student's t-test for paired samples showed a significant improvement in nurses' confidence for the 15 SMS microskills targeted in the training between the pretest and post-test as follows: for Center 1, a mean difference of 0.79 (t = 7.18, p ≤ 0.00001); for Center 2, a mean difference of 0.73 (t = 8.4, p ≤ 0.00001); for Center 3, a mean difference of 1.57 (t = 11.45, p ≤ 0.00001); and for coaches, a mean difference of 0.52 (t = 7.6, p ≤ 0.00001). CONCLUSIONS: Our training program improved oncology staff nurses' and cancer coaches' confidence in 15 SMS microskills and has potential for SMS training of nurses in routine care.

Patient Perceptions of the Impact of the COVID Pandemic on the Quality of Their Gastrointestinal Cancer Care.

We surveyed patients who had a received care for a gastrointestinal cancer between 03/2020 and 05/2021 to understand their perceptions of the impact of the Covid pandemic on cancer care delivery and quality of care. Three-hundred fifty-eight respondents provided evaluable responses (response rate: 17.3%). Approximately half of respondents (46.4%) perceived that they had experienced a pandemic-related cancer care modification; most changes were initiated by a clinician or the cancer center (44.6%). Relative to White patients those from Racialized Groups (OR: 1.91, 95% CI: 1.03-3.54) were more likely to report a cancer treatment change. Additionally, relative to patients in follow-up, those who were newly diagnosed (OR: 2.39; 95% CI: 1.21-4.71) were more likely to report a change. Compared to White patients, patients from Racialized Groups were approximately twice as likely to report perceiving that virtual visits during Covid negatively impacted the quality of their care (OR: 2.21; 95% CI: 0.96-5.08). These findings potentially reflect pre-existing systemic disparities in quality of and access to care, as well as differences in how care is experienced by patients from Racialized Groups.

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.

Impact of Antibiotic Exposure Before Immune Checkpoint Inhibitor Treatment on Overall Survival in Older Adults With Cancer: A Population-Based Study.

PURPOSE: Antibiotic exposure before immune checkpoint inhibitor (ICI) treatment can negatively affect outcomes through alteration in the gut microbiome, but large-scale evaluations are lacking. We performed a population-level retrospective cohort study to evaluate the impact of antibiotic exposure before starting ICI on overall survival (OS). PATIENT AND METHODS: Patients with cancer, age 65 years or older, who initiated treatment with ICIs between June 2012 and October 2018 in Ontario, Canada, were identified using systemic therapy administration data. The cohort was deterministically linked to other health care databases to obtain covariates and antibiotic prescription claim data at both 1 year and 60 days before ICI therapy. Multivariable Cox models evaluated the association between exposure and OS. RESULTS: Among the 2,737 patients with cancer who received ICIs, 59% and 19% of patients received antibiotics 1 year and 60 days before ICI therapy, respectively. Median OS was 306 days. Any antibiotic exposure within 1 year before ICI was associated with worse OS (adjusted hazard ratio [aHR], 1.12; 95% CI, 1.12 to 1.23; P = .03). In antibiotic class analysis, exposure to fluoroquinolones within 1 year (aHR, 1.26; 95% CI, 1.13 to 1.40; P < .001) or 60 days before ICI (aHR, 1.20; 95% CI, 0.99 to 1.45; P = .06) was associated with worse OS, with a dose effect seen on the basis of total weeks of exposure over 1 year (aHR, 1.07 per week; 95% CI, 1.03 to 1.11; P < .001) and 60 days (aHR, 1.12 per week; 95% CI, 1.03 to 1.23; P = .01). CONCLUSION: In this population-level study, exposure to antibiotics and specifically fluoroquinolones before ICI therapy was observed to be associated with worse OS among older adults with cancer. Interventions aimed at altering the gut microbiome to boost immunogenicity may help improve outcomes for patients receiving ICIs with prior antibiotic exposure.

Association of COVID-19 Vaccination With Breakthrough Infections and Complications in Patients With Cancer.

Importance: Patients with cancer are known to have increased risk of COVID-19 complications, including death. Objective: To determine the association of COVID-19 vaccination with breakthrough infections and complications in patients with cancer compared to noncancer controls. Design, Setting, and Participants: Retrospective population-based cohort study using linked administrative databases in Ontario, Canada, in residents 18 years and older who received COVID-19 vaccination. Three matched groups were identified (based on age, sex, type of vaccine, date of vaccine): 1:4 match for patients with hematologic and solid cancer to noncancer controls (hematologic and solid cancers separately analyzed), 1:1 match between patients with hematologic and patients with solid cancer. Exposures: Cancer diagnosis. Main Outcomes and Measures: Outcomes occurring 14 days after receipt of second COVID-19 vaccination dose: primary outcome was SARS-CoV-2 breakthrough infection; secondary outcomes were emergency department visit, hospitalization, and death within 4 weeks of SARS-CoV-2 infection (end of follow-up March 31, 2022). Multivariable cumulative incidence function models were used to obtain adjusted hazard ratio (aHR) and 95% CIs. Results: A total of 289 400 vaccinated patients with cancer (39 880 hematologic; 249 520 solid) with 1 157 600 matched noncancer controls were identified; the cohort was 65.4% female, and mean (SD) age was 66 (14.0) years. SARS-CoV-2 breakthrough infection was higher in patients with hematologic cancer (aHR, 1.33; 95% CI, 1.20-1.46; P < .001) but not in patients with solid cancer (aHR, 1.00; 95% CI, 0.96-1.05; P = .87). COVID-19 severe outcomes (composite of hospitalization and death) were significantly higher in patients with cancer compared to patients without cancer (aHR, 1.52; 95% CI, 1.42-1.63; P < .001). Risk of severe outcomes was higher among patients with hematologic cancer (aHR, 2.51; 95% CI, 2.21-2.85; P < .001) than patients with solid cancer (aHR, 1.43; 95% CI, 1.24-1.64; P < .001). Patients receiving active treatment had a further heightened risk for COVID-19 severe outcomes, particularly those who received anti-CD20 therapy. Third vaccination dose was associated with lower infection and COVID-19 complications, except for patients receiving anti-CD20 therapy. Conclusions and Relevance: In this large population-based cohort study, patients with cancer had greater risk of SARS-CoV-2 infection and worse outcomes than patients without cancer, and the risk was highest for patients with hematologic cancer and any patients with cancer receiving active treatment. Triple vaccination was associated with lower risk of poor outcomes.