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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.

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. 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). 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). 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. 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.

BackgroundMedication 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.MethodsWe 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.ResultsMost 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.ConclusionsRealising 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.

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.

Background Chemotherapy is associated with a significant risk of toxicity, which often peaks between ambulatory visits to the cancer centre. Remote symptom management support is a tool to optimize self-management and healthcare utilization, including emergency department visits and hospitalizations (ED+H) during chemotherapy. We performed a single-arm pilot study to evaluate the feasibility, acceptability, and potential impact of a telephone symptom management intervention on healthcare utilization during chemotherapy for early stage breast cancer (EBC). Methods Women starting adjuvant or neoadjuvant chemotherapy for EBC at two cancer centres in Ontario, Canada, received standardized, nurse-led calls to assess common toxicities at two time points following each chemotherapy administration. Feasibility outcomes included patient enrollment, retention, RN adherence to delivering calls per the study schedule, and resource use associated with calls; acceptability was evaluated based on patient and provider feedback. Impact on acute care utilization was evaluated post hoc by linking individual patient records to provincial data holdings to examine ED+H patterns among participating patients compared to contemporaneous controls. Results Between September 2013 and December 2014, 77 women were enrolled (mean age 55 years). Most commonly used regimens were AC-paclitaxel (58%) and FEC-docetaxel (16%); 78% of patients received primary granulocyte colony-stimulating factor prophylaxis. 83.8% of calls were delivered per schedule; mean call duration was 9 min. The intervention was well received by both patients and clinicians. Comparison of ED+H rates among study participants versus controls showed that there were fewer ED visits in intervention patients [incidence rate ratio (IRR) (95% CI) = 0.54 (0.36, 0.81)] but no difference in the rate of hospitalizations [IRR (95% CI) = 1.02 (0.59, 1.77)]. Main implementation challenges included identifying eligible patients, fitting the calls into existing clinical responsibilities, and effective communication to the patient’s clinical team. Conclusions Telephone-based pro-active toxicity management during chemotherapy is feasible, perceived as valuable by clinicians and patients, and may be associated with lower rates of acute care use. However, attention must be paid to workflow issues for scalability. Larger scale evaluation of this approach is in progress.

IntroductionImproving the quality of self-management support (SMS) for treatment-related toxicities is a priority in cancer care. Successful implementation of SMS programmes depends on tailoring implementation strategies to organisational readiness factors and barriers/enablers, however, a systematic process for this is lacking. In this formative phase of our implementation-effectiveness trial, Self-Management and Activation to Reduce Treatment-Related Toxicities, we evaluated readiness based on constructs in the Consolidated Framework for Implementation Research (CFIR) and Normalisation Process Theory (NPT) and developed a process for mapping implementation strategies to local contexts.MethodsIn this convergent mixed-method study, surveys and interviews were used to assess readiness and barriers/enablers for SMS among stakeholders in 3 disease site groups at 3 regional cancer centres (RCCs) in Ontario, Canada. Median survey responses were classified as a barrier, enabler or neutral based on a priori cut-off values. Barriers/enablers at each centre were mapped to CFIR and then inputted into the CFIR-Expert Recommendations for Implementing Change Strategy Matching Tool V.1.0 (CFIR-ERIC) to identify centre-specific implementation strategies. Qualitative data were separately analysed and themes mapped to CFIR constructs to provide a deeper understanding of barriers/enablers.ResultsSMS in most of the RCCs was not systematically delivered, yet most stakeholders (n=78; respondent rate=50%) valued SMS. For centre 1, 7 barriers/12 enablers were identified, 14 barriers/9 enablers for centre 2 and 11 barriers/5 enablers for centre 3. Of the total 46 strategies identified, 30 (65%) were common across centres as core implementation strategies and 5 tailored implementation recommendations were identified for centres 1 and 3, and 4 for centre 2.ConclusionsThe CFIR and CFIR-ERIC were valuable tools for tailoring SMS implementation to readiness and barriers/enablers, whereas NPT helped to clarify the clinical work of implementation. Our approach to tailoring of implementation strategies may have relevance for other studies.

Virtual care is here to stay but there remains no comprehensive measurement framework to guide evaluation of its impacts, to inform policy decisions and optimization of practice. The aim of our study was to conduct a scoping review of reviews to synthesize measures related to virtual care evaluation across clinical conditions and contexts to identify gaps in current evaluation measures, and to inform the development of recommendations for future work. Citations published from 2015-2023 were retrieved from Medline, Cochrane Database of Systematic Reviews, Embase, Emcare, Scopus, CINAHL and Web of Science, utilizing search terms grouped by key concept (virtual care and evaluation/ quality measurement). Measures were defined as any quantitative or qualitative evaluation of performance or impact of virtual care on processes, outcomes or systems. Articles were excluded if they were not a literature review (primary results, commentaries, letters, protocols), dealt exclusively with pediatric populations, published in a language other than English, or were abstract only. Measures from retained articles (1,233) were thematically grouped against the Proctor Implementation Research Outcomes framework. The study was reported according to the PRISMA guideline extension for scoping reviews. There has been substantial growth in the virtual care literature, particularly since the start of the COVID-19 pandemic. The majority of articles (73.0%; 900/1233) evaluated client outcomes, including satisfaction with virtual care, usability or functionality of platforms, and/or clinical outcomes. Relative to the other domains of the Proctor framework, implementation measures were poorly defined, and many of the measures were proxy rather than direct measures. Despite the potential impacts of virtual care on health equity, most studies examining health equity were purely qualitative. Measures of safety, privacy and security of virtual care were sparse and poorly defined. Caregivers play an important role in facilitating virtual visits and providing informal technical support; however, few studies examined implementation or satisfaction with virtual care from the perspective of caregivers. Additionally, clinician experience and acceptance of virtual care has implications for availability and adoption; however, relative to patients, few articles examined the clinician perspective. Our study highlights gaps in current evaluations of virtual care. Work is needed to improve the quality and standardization of virtual care evaluation to ensure reproducibility, generalizability and comparability of findings. Additionally, better compliance with existing measure definitions and conventions should extend to virtual care. Finally, additional theoretical work is needed to standardize and conceptually frame future virtual care evaluations. Future studies should include both the caregiver and clinician as unique perspectives in evaluations, and should embed systematic evaluations of the impact of social determinants of health on virtual care access, adoption, and perspectives of care.

AbstractObjectiveTo evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer.DesignPragmatic, cluster randomised trial.Setting20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation to remote management of toxicities or routine care.ParticipantsAll patients starting adjuvant or neoadjuvant chemotherapy for early stage breast cancer at each centre. 25 patients from each centre completed patient reported outcome questionnaires.InterventionsProactive, standardised, nurse led telephone management of common toxicities at two time points after each chemotherapy cycle.Main outcome measuresThe 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.ResultsBaseline 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.ConclusionsProactive, 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 registrationClinicalTrials.gov NCT02485678.

Background: The impact of the COVID pandemic on the quality of cancer care delivered remains to be comprehensively evaluated. Objective: Evaluate the quality of cancer care delivered during the early phase of the pandemic at Princess Margaret Cancer Centre with a focus on gastrointestinal cancers. Design: Scoping literature review, cross-sectional survey and retrospective, comparative cohort study. Methods: A scoping review of COVID-related practice changes was undertaken. Patient perceptions of the quality of gastrointestinal cancer care they received during COVID were evaluated using an electronic survey (n=358). Clinical outcomes (all-cause mortality and disease progression) and quality measure performance for a cohort of newly diagnosed patients with colon, rectal or anal cancer during the early phase of the pandemic (02/20-12/20; n=294) were compared to those seen during the same period in the year prior (02/19-12/19; n=335). Results: Similar to the published literature, we found that during the early phase of the pandemic at PM there were fewer new consults, treatment interruptions were common, patient volumes were lower, a greater proportion of patients were diagnosed in the emergency department, fewer patients had surgery, and a greater proportion received short-course radiotherapy for rectal cancer. Most respondents, however, rated the overall quality of their cancer care as excellent or very good, and indicated that they were very likely to recommend PM to family or friends. COVID cohort performance was worse for quality measures related to receipt of appropriate oncology consultations for colon and anal cancer, and receipt of appropriate treatment for rectal and anal cancer, and more patients experienced a 30-day post-surgical readmission. The mean overall quality performance was lower in the COVID cohort than the comparator; however, only stage of disease was associated with score. No significant association between group and time to either all-cause mortality or disease progression was observed. Conclusion: While performance on some quality measures was impacted at the onset of the COVID pandemic, this has not translated into poor patient perceptions of their care, or poorer 2-year clinical outcomes. However, given the observed reduction in new patient consults, impacts of deferred cancer care on prognosis may be more distal.

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.