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Background: Studies found that treatment symptoms of concern to oncology/hematology patients were greatly under-identified in medical records. On average, 11.0 symptoms were reported of concern to patients compared to 1.5 symptoms identified in their medical records. A solution to this problem is use of an electronic symptom checklist that can be easily accessed by patients prior to clinical consultations., Purpose: Describe the oncology Therapy-Related Symptom Checklists for Adults (TRSC) and Children (TRSC-C), which are validated bases for e-Health symptom documentation and management. The TRSC has 25 items/symptoms; the TRSC-C has 30 items/symptoms. These items capture up to 80% of the variance of patient symptoms. Measurement properties and applications with outpatients are presented. E-Health applications are indicated., Methods: The TRSC was developed for adults (N = 282) then modified for children (N = 385). Statistical analyses have been done using correlational, epidemiologic, and qualitative methods. Extensive validation of measurement properties has been reported., Results: Research has found high levels of patient/clinician satisfaction, no increase in clinic costs, and strong correlations of TRSC/TRSC-C with medical outcomes. A recently published sequential cohort trial with adult outpatients at a Mayo Clinic community cancer center found TRSC use produced a 7.2% higher patient quality of life, 116% more symptoms identified/managed, and higher functional status., Discussion, Implications, and Follow-Up: An electronic system has been built to collect TRSC symptoms, reassure patients, and enhance patient-clinician communications. This report discusses system design and efforts made to provide an electronic system comfortable to patients. Methods used by clinicians to promote comfort and patient engagement were examined and incorporated into system design. These methods included (a) conversational data collection as opposed to survey style or standardized questionnaires, (b) short response phrases indicating understanding of the reported symptom, (c) use of open-ended questions to reduce long lists of symptoms, (d) directed questions that ask for confirmation of expected symptoms, (e) review of symptoms at designated stages, and (d) alerting patients when the computer has informed clinicians about patient-reported symptoms., Conclusions: An e-Health symptom checklist (TRSC/TRSC-C) can facilitate identification, monitoring, and management of symptoms; enhance patient-clinician communications; and contribute to improved patient outcomes.

Background: Cancer treatment efficacy has improved with therapies at high or sustained dosages. However, there is increasing concern about symptom management and patients' quality of life., Objective: The objective of this study was to assess whether use of a Therapy-Related Symptom Checklist (TRSC) with oncology outpatients increases the number of symptoms documented and managed and whether this improves patients' health-related quality of life (HRQOL)., Methods: This was a sequential cohort trial. Fifty-five oncology outpatients in treatment received standard of care (group 1, G1). Afterward, another 58 patients (group 2, G2) received standard of care at the same clinic; however, these patients additionally answered the TRSC immediately prior to each consultation. The TRSC results were then shared with clinicians. Repeated measures (2-11 visits) were obtained of the number of patient treatment symptoms documented (medical records G1 and TRSC G2), HRQOL, and Karnofsky scores, n = 696 observations (328 G1 and 368 G2). The number of symptoms reported and HRQOL were covariate adjusted using population averaged generalized estimating equations., Results: G2 patients had a 7.2% higher population averaged covariate-adjusted HRQOL than G1 patients (3.3 more points on HRQOL, P = .012). One hundred sixteen percent more covariate- and non-covariate-adjusted symptoms were documented/managed in G2 than G1 (6.14 symptoms vs 2.84, P < .0001). The HRQOL, TRSC, and Karnofsky scores correlated r > 0.40., Conclusion: Use of patient-reported TRSC improves symptom documentation/management and patient HRQOL., Implications for Practice: Study findings were consistent with recent research that has shown that use of checklists can have powerful influences on both quality and safety of healthcare services and patient outcomes.

Purpose: To establish the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), safety, and pharmacokinetic profile of ispinesib when administered as a 1-h intravenous infusion weekly for three consecutive weeks of a 28 day treatment period to patients with advanced solid tumors., Experimental Design: Thirty patients were enrolled using an initial accelerated dose-escalation phase followed by a standard dose-escalation phase at doses ranging from 1-8 mg/m(2)/week. Pharmacokinetic samples, skin punch biopsies, and tumor biopsies (in patients with accessible tumor) were obtained during cycle 1 of treatment. Disease assessment was performed every two treatment cycles., Results: The MTD was defined as 7 mg/m(2) administered as a 1-h infusion weekly for three consecutive weeks of a 28 day schedule. The MTD was exceeded at 8 mg/m(2) due to DLTs of grade 2 (one patient) and grade 3 neutropenia (one patient) that resulted in the inability to administer the Day 15 dose in Cycle 1. The neutrophil nadir occurred at approximately Day 8 with a 3-7 day recovery period. The most common toxicities were nausea, diarrhea, fatigue, and neutropenia. Alopecia, mucositis, and neuropathy were not observed. Stable disease was reported as the best response to treatment in nine patients., Conclusion: The recommended dose of ispinesib is 7 mg/m(2) over 1 h weekly for three consecutive weeks of a 28 day treatment cycle.

The aim of this study is to define the maximum tolerated dose (MTD), safety, pharmacokinetics (PKs) and efficacy of ispinesib (SB-715992) in combination with docetaxel. Patients with advanced solid tumours were treated with ispinesib (6-12 mg m(-2)) and docetaxel (50-75 mg m(-2)). Docetaxel was administered over 1 h followed by a 1-h infusion of ispinesib on day 1 of a 21-day schedule. At least three patients were treated at each dose level. Blood samples were collected during cycle 1 for PK analysis. Clinical response assessments were performed every two cycles using RECIST guidelines. Twenty-four patients were treated at four dose levels. Prolonged neutropaenia and febrile neutropaenia were dose limiting in six and two patients, respectively. The MTD was ispinesib 10 mg m(-2) with docetaxel 60 mg m(-2). Pharmacokinetic assessment demonstrated concentrations of ispinesib and docetaxel, consistent with published data from single agent studies of the drugs. Seven patients (six hormone refractory prostate cancer (HRPC), one renal cancer) had a best response of stable disease (>or=18 weeks). One patient with HRPC had a confirmed >50% prostatic-specific antigen decrease. The MTD for ispinesib and docetaxel was defined and the combination demonstrated an acceptable toxicity profile. Preliminary PK data suggest no interaction between ispinesib and docetaxel.