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      Assessment of adverse events via a telephone consultation service for cancer patients receiving ambulatory chemotherapy

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          Abstract

          Background

          An increasing number of cancer patients are receiving ambulatory chemotherapy to improve their quality of life and reduce medical expenses. During outpatient chemotherapy, adverse events (AEs) occurring at home must be carefully monitored. We investigated the use of our institution’s telephone consultation service that is available to patients and their caregivers for advice on and the management of AEs and complications arising from cancer treatment.

          Patients and methods

          Telephone consultants assessed and graded AEs according to the Common Terminology Criteria for Adverse Events (CTCAE). All patient characteristics, AEs, and background factors were analyzed using logistic regression analyses.

          Results

          Between August 2011 and August 2012, we included 253 patients and 344 telephone consultations regarding AEs during chemotherapy for analysis in this study. Grade 1 AEs were assessed in 223 consultations (65%); grade 2 AEs, in 90 consultations (26%); and grade 3 AEs, in 31 consultations (9%). A multivariate logistic regression analysis revealed an association between a change in patient schedules and the occurrence of grade 2 or worse AEs (Hazard ratio = 6.58, P < 0.001). Changes in planned chemotherapy occurred more often in cases involving male patients (Hazard ratio = 2.70, P = 0.02) and in cases of grade 2 or worse AEs (Hazard ratio = 6.58, P < 0.001).

          Conclusion

          We found that AE assessment using CTCAE via a telephone consultation service is useful for both the triage of patients and the prediction of severe AEs that may change clinical schedules.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13104-015-1292-8) contains supplementary material, which is available to authorized users.

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          Most cited references8

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          Effect of telecare management on pain and depression in patients with cancer: a randomized trial.

          Pain and depression are 2 of the most prevalent and treatable cancer-related symptoms, yet they frequently go unrecognized, undertreated, or both. To determine whether centralized telephone-based care management coupled with automated symptom monitoring can improve depression and pain in patients with cancer. Randomized controlled trial conducted in 16 community-based urban and rural oncology practices involved in the Indiana Cancer Pain and Depression (INCPAD) trial. Recruitment occurred from March 2006 through August 2008 and follow-up concluded in August 2009. The participating patients had depression (Patient Health Questionnaire-9 score > or = 10), cancer-related pain (Brief Pain Inventory [BPI] worst pain score > or = 6), or both. The 202 patients randomly assigned to receive the intervention and 203 to receive usual care were stratified by symptom type. Patients in the intervention group received centralized telecare management by a nurse-physician specialist team coupled with automated home-based symptom monitoring by interactive voice recording or Internet. Blinded assessment at baseline and at months 1, 3, 6, and 12 for depression (20-item Hopkins Symptom Checklist [HSCL-20]) and pain (BPI) severity. Of the 405 participants enrolled in the study, 131 had depression only, 96 had pain only, and 178 had both depression and pain. Of the 274 patients with pain, 137 patients in the intervention group had greater improvements in BPI pain severity over the 12 months of the trial whether measured as a continuous severity score or as a categorical pain responder (> or = 30% decrease in BPI) than the 137 patients in the usual-care group (P or = 50% decrease in HSCL) than the 155 patients in the usual care group (P < .001 for both). The standardized effect size for between-group differences at 3 and 12 months was 0.67 (95% confidence interval [CI], 0.33-1.02) and 0.39 (95% CI, 0.01-0.77) for pain, and 0.42 (95% CI, 0.16-0.69) and 0.41 (95% CI, 0.08-0.72) for depression. Centralized telecare management coupled with automated symptom monitoring resulted in improved pain and depression outcomes in cancer patients receiving care in geographically dispersed urban and rural oncology practices. clinicaltrials.gov Identifier: NCT00313573.
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            Common terminology criteria for adverse events (CTCAE) version 4.0

            (2009)
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              Normal tissue effects: reporting and analysis.

              Any effective cancer therapy developed to date is associated with a spectrum of normal tissue effects of varying incidence and severity. With an increasing number of novel therapeutic approaches undergoing clinical testing and an increased effort to optimize the established treatment modalities, methods for reliable quantification of normal tissue effects have become a key element in advancing cancer care. Here, we present a review of many of the issues involved in reporting and analyzing clinical normal tissue effect data. A distinction is introduced between explorative (science-driven) and pragmatic (patient-centered) studies. The desirable properties of criteria for reporting and grading toxicity are discussed from a biological and clinical perspective. Validation of toxicity criteria and the statistical issues involved in analyzing this type of data are presented with special emphasis on descriptors of the time evolution of toxicity. Finally, we discuss surrogate markers for late effects, mechanistic studies, and the design of clinical studies with normal tissue endpoints as a primary outcome. It is concluded that a consensus is required on guidelines for the reporting of normal tissue effects to improve the comparability of published reports on treatment outcome.
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                Author and article information

                Contributors
                shkondo@ncc.go.jp
                sashiba@ncc.go.jp
                ryudagaw@east.ncc.go.jp
                yryshim@east.ncc.go.jp
                mhsuzuki@ncc.go.jp
                tmuehara@ncc.go.jp
                masanabe@ncc.go.jp
                ketamura@ncc.go.jp
                juhashim@ncc.go.jp
                Journal
                BMC Res Notes
                BMC Res Notes
                BMC Research Notes
                BioMed Central (London )
                1756-0500
                26 July 2015
                26 July 2015
                2015
                : 8
                : 315
                Affiliations
                Outpatient Treatment Center, National Cancer Center Hospital, 5-1-1 Tsukiji Chuo-ku, Tokyo, 104-0045 Japan
                Article
                1292
                10.1186/s13104-015-1292-8
                4514970
                aa60f8ed-f1a8-47ee-a2a8-748046044eb3
                © Kondo et al. 2015

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 20 May 2014
                : 22 July 2015
                Categories
                Research Article
                Custom metadata
                © The Author(s) 2015

                Medicine
                telephone consultation service,ambulatory chemotherapy,ctcae,triage
                Medicine
                telephone consultation service, ambulatory chemotherapy, ctcae, triage

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