Clauser, Steven B.

9047 Background: Symptomatic adverse events (AE) in cancer trials are reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective into AE reporting, NCI contracted (HHSN261201000043C) to create a patient-reported outcomes companion tool (PRO-CTCAE). We report the validity and reliability of PRO-CTCAE’s 124 items reflecting 78 symptomatic AEs. Methods: English-speaking subjects (n=869; 44% male; median [mdn] age 59; 32% racial/ethnic minority; 34% high school or less; 17% ECOG Performance Status [PS] 2-4) receiving treatment for a range of cancers at 4 NCI-designated cancer centers and 5 sites in NCI's Community Cancer Centers Program completed a web-based survey in clinic including PRO-CTCAE and EORTC QLQ-C30. Pearson correlations were computed between PRO-CTCAE items and QLQ-C30 scales. Differences in PRO-CTCAE item scores between clinician-reported ECOG PS (0-1 vs 2-4) groups were computed. Test-retest reliability of 48 prespecified items was evaluated in a subset (n=79). Results: Correlations in the expected direction were observed for 116/124 PRO-CTCAE items with the QLQ-C30 global health scale (mdn r=-.21; range .08 to -.57). Stronger correlations were seen for PRO-CTCAE items with conceptually related QLQ-C30 domains: fatigue with physical, role and social functioning (-.54 to -.66); anxiety and depression with emotional functioning (-.54 to -.70); and concentration and memory problems with cognitive functioning (-.62 to -.72) [all p <0.001]. Fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation and diarrhea items strongly correlated with corresponding QLQ-C30 symptom scales (.69 to .79, all p <0.001). Scores for 98/124 PRO-CTCAE items were higher in the ECOG PS 2-4 vs 0-1 group (mdn effect size .3). Test-retest reliability was observed across all tested items (mdn intraclass correlation coeff .77; range .53 to .96). Conclusions: Results demonstrate favorable validity and reliability of PRO-CTCAE in a large, heterogeneous sample of patients undergoing cancer treatment. Further testing in multicenter treatment trials is underway.

BACKGROUNDThe current study was performed to determine whether patient characteristics, including race/ethnicity, were associated with patient‐reported care coordination for patients with colorectal cancer (CRC) who were treated in the Veterans Affairs (VA) health care system, with the goal of better understanding potential goals of quality improvement efforts aimed at improving coordination.METHODSThe nationwide Cancer Care Assessment and Responsive Evaluation Studies survey involved VA patients with CRC who were diagnosed in 2008 (response rate, 67%). The survey included a 4‐item scale of patient‐reported frequency (“never,” “sometimes,” “usually,” and “always”) of care coordination activities (scale score range, 1‐4). Among 913 patients with CRC who provided information regarding care coordination, demographics, and symptoms, multivariable logistic regression was used to examine odds of patients reporting optimal care coordination.RESULTSVA patients with CRC were found to report high levels of care coordination (mean scale score, 3.50 [standard deviation, 0.61]). Approximately 85% of patients reported a high level of coordination, including the 43% reporting optimal/highest‐level coordination. There was no difference observed in the odds of reporting optimal coordination by race/ethnicity. Patients with early‐stage disease (odds ratio [OR], 0.60; 95% confidence interval [95% CI], 0.45‐0.81), greater pain (OR, 0.97 for a 1‐point increase in pain scale; 95% CI, 0.96‐0.99), and greater levels of depression (OR, 0.97 for a 1‐point increase in depression scale; 95% CI, 0.96‐0.99) were less likely to report optimal coordination.CONCLUSIONSPatients with CRC in the VA reported high levels of care coordination. Unlike what has been reported in settings outside the VA, there appears to be no racial/ethnic disparity in reported coordination. However, challenges remain in ensuring coordination of care for patients with less advanced disease and a high symptom burden. Cancer 2015;121:2207–2213. © 2015 American Cancer Society.

Purpose High-quality supportive care is an essential component of comprehensive cancer care. We implemented a patient-centered quality of cancer care survey to examine and identify predictors of quality of supportive care for bowel problems, pain, fatigue, depression, and other symptoms among 1,109 patients with colorectal cancer. Patients and Methods Patients with new diagnosis of colorectal cancer at any Veterans Health Administration medical center nationwide in 2008 were ascertained through the Veterans Affairs Central Cancer Registry and sent questionnaires assessing a variety of aspects of patient-centered cancer care. We received questionnaires from 63% of eligible patients (N = 1,109). Descriptive analyses characterizing patient experiences with supportive care and binary logistic regression models were used to examine predictors of receipt of help wanted for each of the five symptom categories. Results There were significant gaps in patient-centered quality of supportive care, beginning with symptom assessment. In multivariable modeling, the impact of clinical factors and patient race on odds of receiving wanted help varied by symptom. Coordination of care quality predicted receipt of wanted help for all symptoms, independent of patient demographic or clinical characteristics. Conclusion This study revealed substantial gaps in patient-centered quality of care, difficult to characterize through quality measurement relying on medical record review alone. It established the feasibility of collecting patient-reported quality measures. Improving quality measurement of supportive care and implementing patient-reported outcomes in quality-measurement systems are high priorities for improving the processes and outcomes of care for patients with cancer.