Advancing Digital Health Innovation in Oncology: Priorities for High-Value Digital Transformation in Cancer Care.

Although health care delivery is becoming increasingly digitized, driven by the pursuit of improved access, equity, efficiency, and effectiveness, progress does not appear to be equally distributed across therapeutic areas. Oncology is renowned for leading innovation in research and in care; digital pathology, digital radiology, real-world data, next-generation sequencing, patient-reported outcomes, and precision approaches driven by complex data and biomarkers are hallmarks of the field. However, remote patient monitoring, decentralized approaches to care and research, "hospital at home," and machine learning techniques have yet to be broadly deployed to improve cancer care. In response, the Digital Medicine Society and Moffitt Cancer Center convened a multistakeholder roundtable discussion to bring together leading experts in cancer care and digital innovation. This viewpoint highlights the findings from these discussions, in which experts agreed that digital innovation is lagging in oncology relative to other therapeutic areas. It reports that this lag is most likely attributed to poor articulation of the challenges in cancer care and research best suited to digital solutions, lack of incentives and support, and missing standardized infrastructure to implement digital innovations. It concludes with suggestions for actions needed to bring the promise of digitization to cancer care to improve lives.

Oncology Medical Home: ASCO and COA Standards.

PURPOSE: To provide Standards on the basis of evidence and expert consensus for a pilot of the Oncology Medical Home (OMH) certification program. The OMH model is a system of care delivery that features coordinated, efficient, accessible, and evidence-based care and includes a process for measurement of outcomes to facilitate continuous quality improvement. The OMH pilot is intended to inform further refinement of Standards for OMH model implementation. METHODS: An Expert Panel was formed, and a systematic review of the literature on the topics of OMH, clinical pathways, and survivorship care plans was performed using PubMed and Google Scholar. Using this evidence base and an informal consensus process, the Expert Panel developed a set of OMH Standards. Public comments were solicited and considered in preparation of the final manuscript. RESULTS: Three comparative peer-reviewed studies of OMH met the inclusion criteria. In addition, the results from 16 studies of clinical pathways and one systematic review of survivorship care plans informed the evidence review. Limitations of the evidence base included the small number of studies of OMH and lack of longer-term outcomes data. More data were available to inform the specific Standards for pathways and survivorship care; however, outcomes were mixed for the latter intervention. The Expert Panel concluded that in the future, practices should be encouraged to publish the results of OMH interventions in peer-reviewed journals to improve the evidence base. STANDARDS: Standards are provided for OMH in the areas of patient engagement, availability and access to care, evidence-based medicine, equitable and comprehensive team-based care, quality improvement, goals of care, palliative and end-of-life care discussions, and chemotherapy safety. Additional information, including a Standards implementation manual, is available at www.asco.org/standards.

Integrating Somatic and Germline Next-Generation Sequencing Into Routine Clinical Oncology Practice.

Next-generation sequencing (NGS) is rapidly expanding into routine oncology practice. Genetic variations in both the cancer and inherited genomes are informative for hereditary cancer risk, prognosis, and treatment strategies. Herein, we focus on the clinical perspective of integrating NGS results into patient care to assist with therapeutic decision making. Five key considerations are addressed for operationalization of NGS testing and application of results to patient care as follows: (1) NGS test ordering and workflow design; (2) result reporting, curation, and storage; (3) clinical consultation services that provide test interpretations and identify opportunities for molecularly guided therapy; (4) presentation of genetic information within the electronic health record; and (5) education of providers and patients. Several of these key considerations center on informatics tools that support NGS test ordering and referencing back to the results for therapeutic purposes. Clinical decision support tools embedded within the electronic health record can assist with NGS test utilization and identifying opportunities for targeted therapy including clinical trial eligibility. Challenges for project and change management in operationalizing NGS-supported, evidence-based patient care in the context of current information technology systems with appropriate clinical data standards are discussed, and solutions for overcoming barriers are provided.

Transitioning Clinical Practice Guidelines into the Electronic Health Record through Clinical Pathways.

Clinical practice guidelines in oncology provide an evidence-based roadmap for most cancer care delivery but often lack directions for specific patient factors and disease conditions. Clinical pathways serve as a real-time clinical decision support system to translate guidelines to clinical practice. Pathways allow for the creation of a standardized, multidimensional roadmap for the continuum of care that can support clinical decision-making, maintain optimal outcomes, and limit unnecessary variation in cancer care. Here we describe the process to develop and implement clinical pathways in the electronic health record. This process includes building the appropriate foundation for a clinical pathways team with supports in the institutional ecosystem, creating visual representations of care paths, formalizing the pathway approval process, and translating clinical pathways into an electronic health record-integrated clinical decision support tool.

Phase I Study of Topotecan, Ifosfamide, and Etoposide (TIME) with autologous stem cell transplant in refractory cancer: pharmacokinetic and pharmacodynamic correlates.

PURPOSE: To determine the maximum tolerated dose (MTD) of topotecan in combination with ifosfamide, mesna, and etoposide (TIME), followed by autologous hematopoietic cell transplant (HCT), in patients with chemotherapy-refractory malignancies. EXPERIMENTAL DESIGN: Patients were treated with (in mg/m(2)/d) ifosfamide 3,333, mesna 3,333, and topotecan 3.3 to 28.3 during days -8 through -6 and etoposide 500 (days -5 through -3) followed by HCT on day 0. Once MTD was defined, we expanded this dosing cohort to include patients with high-risk lymphoma due to activity seen during dose escalation. Topotecan pharmacokinetic analyses were carried out, and topoisomerase I levels and activity were measured. RESULTS: The topotecan MTD in this regimen was 64 mg/m(2) (21.3 mg/m(2)/d). Mucositis was dose limiting and correlated with topotecan dose level and area under the curve (AUC). Dose level was also correlated with length of hospitalization, number of days of parenteral nutrition, and neutrophil and platelet engraftment. Topotecan AUC was significantly correlated with time to platelet recovery. The baseline peripheral blood mononuclear cell topoisomerase I level was found to be a significant positive predictor for overall and progression-free survival. Topotecan AUC was positively correlated with dose level, with a trend toward decreasing clearance with increasing dose. CONCLUSION: Topotecan can be a useful drug in the high-dose setting given its activity in some malignancies when given in standard dose. Pharmacokinetic monitoring may be a valuable tool for optimizing the use of topotecan and to avoid toxicity seen with high-systemic exposures. Baseline topoisomerase I levels may have an important role in predicting topotecan efficacy.

Changes in cognitive functioning in the year after hematopoietic stem cell transplantation.

BACKGROUND: The current study examined changes in multiple domains of cognitive functioning of hematopoietic stem cell transplantation (HSCT) candidates tested pretransplantation, 6 months posttransplantation, and 12 months posttransplantation. METHODS: Using a sequential longitudinal design, 476 patients were randomized to be tested at all 3 time points, at 6 and 12 months posttransplantation, or at only 12 months posttransplantation. Participants completed a comprehensive battery of neuropsychologic tests that indexed memory, psychomotor speed, attention, and executive functioning, and provided a total neuropsychologic performance score (TNP). RESULTS: The results indicate that performance on cognitive abilities, except for attention, significantly improved across the 1-year follow-up period after HSCT. Performance on the TNP and all cognitive domains was superior or equal to population normative values by the 12-month measurement point. The results also indicate that repeated exposure to tests led to better performance on motor speed and the TNP and that attrition influenced the TNP, such that those who remained in the longitudinal sample exhibited greater longitudinal improvement in scores as compared with patients who left the sample. CONCLUSIONS: The findings of the current study suggest that although patients undergoing HSCT experience cognitive deficits during the period just before transplantation, cognitive functioning returns to normative values within a year after transplantation.

Predictors of posttraumatic growth following bone marrow transplantation for cancer.

There is growing recognition that the experience of cancer can have a positive as well as a negative psychological impact. This longitudinal study sought to identify predictors of posttraumatic growth among cancer patients (N=72) undergoing bone marrow transplantation. Greater posttraumatic growth in the posttransplant period was related to younger age; less education; greater use of positive reinterpretation, problem solving, and seeking alternative rewards as coping strategies in the pretransplant period; more stressful appraisal of aspects of the transplant experience; and more negatively biased recall of pretransplant levels of psychological distress. Findings partially support J. A. Schaefer and R. H. Moos's (1992) model of life crises and personal growth and also suggest that temporal self-comparisons contribute to the experience of posttraumatic growth.

Preliminary evaluation of a clinical syndrome approach to assessing cancer-related fatigue.

The objectives of this study were to evaluate the reliability, validity, and utility of a newly developed clinical syndrome approach to assessing cancer-related fatigue. Fifty-one patients who underwent blood or marrow transplantation an average of 6.9 months previously were administered a standardized interview designed to identify the presence of a clinical syndrome of cancer-related fatigue. Patients also completed self-report measures of fatigue, depression, and health-related quality of life. Comparisons among independent raters demonstrated high rates of reliability for the presence or absence of a cancer-related fatigue syndrome and its symptoms. Twenty-one percent of patients (n = 11) were found to meet criteria for diagnosis of a cancer-related fatigue syndrome. Compared to patients not meeting the diagnostic criteria, patients meeting the criteria reported fatigue that was greater (P < or = 0.05) in its severity, frequency, pervasiveness, and interference with quality of life. Patients who met criteria also demonstrated poorer role functioning, less vitality, and more depressive symptomatology (P < or = 0.05). These findings provide preliminary evidence of the reliability and validity of the methods used to assess the proposed clinical syndrome and suggest their utility in identifying patients experiencing clinically significant cancer-related fatigue.

Predictors of posttraumatic stress disorder symptomatology following bone marrow transplantation for cancer.

This study examined the prevalence and predictors of posttraumatic stress disorder (PTSD) symptoms in 70 men and women treated with bone marrow transplantation for cancer. Findings indicated that the number of symptoms present ranged from 0 to a possible high of 17 (M = 3.0, SD = 3.9). As predicted. lower social support and higher avoidance coping I month pretransplant predicted greater PTSD symptom severity an average of 7 months posttransplant. These variables remained significant predictors of symptom severity even after accounting for pretransplant levels of psychological distress. Additional analyses indicated the presence of a significant interaction between social support and avoidance coping, with patients high in avoidance coping and low in social support reporting the most severe symptoms. These findings identify patients at risk for psychological disturbance posttransplant and can serve to guide future intervention efforts.