Montemurro et al 2015 Adverse Effects Jama Oncology (original) (raw)
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Self-Evaluation of Adjuvant Chemotherapy-Related Adverse Effects by Patients With Breast Cancer
JAMA Oncology, 2015
ranging from 0.10 for anorexia to 0.51 for vomiting (Cohen's kappa statistic). There was a strong and significant positive correlation between the magnitude of the discrepancy in the frequency of reporting side effects and the number of patients enrolled at each site. Conclusions and relevance: Adherence to reporting adjuvant chemotherapy-related side effects using the CTCAE system is high in women undergoing adjuvant chemotherapy for breast cancer. Workload may contribute to agreement discrepancies by limiting the doctorpatient relationship.
Cancer medicine, 2018
We recently reported that self-evaluation of the incidence and severity of treatment-related side effects (TSEs) using a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0-based questionnaire was feasible and more informative than doctor reports in patients undergoing standard adjuvant chemotherapy for operable breast cancer. Here, we compare self- and doctor-evaluated day of onset and duration of TSEs in the same population. Six hundred and four patients were enrolled at 11 sites in Italy. CTCAE v4.0 definitions of grade of severity of nausea, vomiting, constipation, anorexia, dysgeusia, diarrhea, fatigue, pain, paresthesia, and dyspnea were translated into Italian and rephrased. Questionnaires were administered after the first and third chemotherapy cycles. At each time-point, information on TSEs was extracted from the medical charts and compared to patient questionnaires. A total of 594 and 573 paired patient and doctor questionnaires were...
Oncology and Therapy, 2018
Introduction: Systematic documentation of chemotoxicities in outpatient clinics is challenging. Incorporating patient-reported outcome (PRO) measures in clinical workflows can be an efficient strategy to strengthen the assessment of symptomatic treatment toxicities in oncology clinical practice. We compared the adequateness, feasibility, and acceptability of toxicity documentation using systematic, prospective, application of the PRO Common Toxicity Criteria for Adverse Events (PRO-CTCAE) tool. Methods: At a comprehensive cancer center, data abstraction of electronic health record reviews elucidated current methods and degree of chemotoxicity documentation. Web-based 32-item PRO-CTCAE questionnaires, administered in ambulatory clinics of patients receiving chemotherapy, captured chemotoxicities and respective severities. Patient telephone surveys assessed whether healthcare providers had addressed chemotoxicities to the patients' satisfaction. Results: Over a broad demographic of 497 patients receiving chemotherapy, 90% (95% CI 84-96%) with significant chemotoxicities (n = 107) reported that their providers had discussed toxicities with them; of these, 70% received a therapy management change, while among the rest, 17% desired a change in management. Of patients surveyed, 91% (95% CI 82-99%) were satisfied with their current chemotoxicity management. Clinician chart documentation varied greatly; descriptors rather than numerical grading scales were typically used. Although 93% of patients were willing to complete the PRO survey, only 50% thought that it would be acceptable to complete this survey at routine clinic visits. Conclusion: Use of PRO-CTCAE in routine clinical practice promotes systematic evaluation of symptomatic toxicities and improves the clarity, consistency, and efficiency of clinician documentation; however, methods to improve patient willingness to complete this tool routinely are needed.
Patient Online Self-Reporting of Toxicity Symptoms During Chemotherapy
Journal of Clinical Oncology, 2005
Purpose Tracking symptoms related to treatment toxicity is standard practice in routine care and during clinical trials. Currently, clinicians collect symptom information via complex and often inefficient mechanisms, but there is growing interest in collecting outcome information directly from patients. Patients and Methods The National Cancer Institute Common Terminology Criteria for Adverse Events schema for seven common symptoms was adapted into a Web-based patient-reporting system, accessible from desktop computers in outpatient clinics and from home computers. Eighty patients with gynecologic malignancies beginning standard chemotherapy regimens were enrolled between April and September 2004. During an 8-week observation period, participants were encouraged to log in and report symptoms at each follow-up visit, or alternatively, to access the system from home. Results All patients completed an initial log in. At each subsequent appointment, most enrollees (80% to 85%) reported ...
2010
Patients with breast cancer receiving chemotherapy are at risk of developing toxicities which can be severe or life threatening. The aim of this study was to develop and test a side effect risk modeling tool (ASyMS © -SERAT) for use in patients with breast cancer undergoing adjuvant chemotherapy. The study was conducted in two phases. Phase 1 entailed the development of the ASyMS © -SERAT tool using a secondary data set and in collaboration with an expert group of clinicians and an advisory group of patients. In phase 2, the predictive accuracy of the tool was measured using a prospective data set of 24 patients with breast cancer undergoing adjuvant chemotherapy. A high level of accuracy was reported for four of the six symptoms measured (>70%) supporting the future development and application of ASyMS © -SERAT in the prediction of chemotherapy-related toxicity. For patients, such information can be used to target information on side effects that they are likely to experience thereby facilitating the provision of tailored information based on their individual needs. For clinicians, knowing the likelihood of potential side effects can assist them in identifying patients who are at greater risk of developing certain toxicities, facilitating more targeted and cost-effective interventions.
Journal of Clinical Oncology, 2015
Purpose Information about symptomatic toxicities of anticancer treatments is not based on direct report by patients, but rather on reports by clinicians in trials. Given the potential for under-reporting, our aim was to compare reporting by patients and physicians of six toxicities (anorexia, nausea, vomiting, constipation, diarrhea, and hair loss) within three randomized trials. Patients and Methods In one trial, elderly patients with breast cancer received adjuvant chemotherapy; in two trials, patients with advanced non–small-cell lung cancer received first-line treatment. Toxicity was prospectively collected by investigators (graded by National Cancer Institute Common Toxicity Criteria [version 2.0] or Common Terminology Criteria for Adverse Events [version 3]). At the end of each cycle, patients completed the European Organisation for Research and Treatment of Cancer quality-of-life questionnaires, including toxicity-related symptom items. Possible answers were “not at all,” “a ...
American Society of Clinical Oncology Educational Book, 2016
Systematic capture of the patient perspective can inform the development of new cancer therapies. Patient-reported outcomes (PROs) are commonly included in cancer clinical trials; however, there is heterogeneity in the constructs, measures, and analytic approaches that have been used making these endpoints challenging to interpret. There is renewed effort to identify rigorous methods to obtain high-quality and informative PRO data from cancer clinical trials. In this setting, PROs are used to address specific research objectives, and an important objective that spans the product development life cycle is the assessment of safety and tolerability. The U.S. Food and Drug Administration's (FDA) Office of Hematology and Oncology Products (OHOP) has identified symptomatic adverse events (AEs) as a central PRO concept, and a systematic assessment of patient-reported symptomatic AEs can provide data to complement clinician reporting. The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being evaluated by multiple stakeholders, including the FDA, and is considered a promising tool to provide a standard yet flexible method to assess symptomatic AEs from the patient perspective. In this article, we briefly review the FDA OHOP's perspective on PROs in cancer trials submitted to the FDA and focus on the assessment of symptomatic AEs using PRO-CTCAE. We conclude by discussing further work that must be done to broaden the use of PRO-CTCAE as a method to provide patient-centered data that can complement existing safety and tolerability assessments across cancer clinical trials.
Journal of Research in Nursing, 2009
Patients with breast cancer receiving chemotherapy are at risk of developing toxicities which can be severe or life threatening. The aim of this study was to develop and test a side effect risk modeling tool (ASyMS © -SERAT) for use in patients with breast cancer undergoing adjuvant chemotherapy. The study was conducted in two phases. Phase 1 entailed the development of the ASyMS © -SERAT tool using a secondary data set and in collaboration with an expert group of clinicians and an advisory group of patients. In phase 2, the predictive accuracy of the tool was measured using a prospective data set of 24 patients with breast cancer undergoing adjuvant chemotherapy. A high level of accuracy was reported for four of the six symptoms measured (>70%) supporting the future development and application of ASyMS © -SERAT in the prediction of chemotherapy-related toxicity. For patients, such information can be used to target information on side effects that they are likely to experience thereby facilitating the provision of tailored information based on their individual needs. For clinicians, knowing the likelihood of potential side effects can assist them in identifying patients who are at greater risk of developing certain toxicities, facilitating more targeted and cost-effective interventions.
Breast Cancer Research and Treatment, 2006
Background Adjuvant chemotherapy for primary breast cancer is associated with significant side effects. The aims of this study were (1) to compare healthrelated quality of life (HRQL) in patients undergoing adjuvant chemotherapy to patients not on chemother-apy and (2) to compare these results against a survey investigating health-care professionals' knowledge of HRQL. Methods Patients on adjuvant cyclophosphamide, methotrexate, fluoracil chemotherapy were compared to 'low-risk' patients not on chemotherapy ('control group'). A questionnaire including the EORTC QLQ-C30, the Hospital Anxiety and Depression Scale (HADS), and the DBCG 89 Questionnaire was administered six times during a 2-year period. Forty-six experienced health-care professionals were asked which quality-of-life issues they thought were affected by adjuvant chemotherapy. Results After 2 years, 159 of 242 patients on chemotherapy and 148 of 199 patients in the control group were alive and recurrence-free and had completed all questionnaires. Worse HRQL during chemotherapy was seen, as had been previously suggested, for 23 of 30 variables. A number of the health-care professionals had not indicated patients to have these side effects. Several side effects persisted after the chemotherapy. Conclusions This study provides the most comprehensive description of HRQL in adjuvant therapy to date. The discrepancy between patients and doctors/ nurses suggests that patients have been insufficiently informed about the impact of chemotherapy on quality of life. The results of this study provide a basis for information that can be given to patients, and indicate that the care offered to patients in chemotherapy should seek to prevent, identify, and alleviate a very broad range of problems.