BackgroundThe US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general.ResultsTwenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events.ConclusionsThe study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items.

Background:As the advent of genomic technology accelerates personalized medicine and complex care, multidisciplinary care is essential for management of breast cancer.Objectives:To assess whether healthcare delivery systems are related to patients’ perceptions of care in breast cancer treatment institutions.Methods:We conducted a cross-sectional nationwide study of breast cancer treatment institutions approved by the Japanese Breast Cancer Society in Japan. From 128 of the 457 institutions, 1,206 patients were included in the analysis. Each patient completed a questionnaire regarding perceptions of care that consisted of a multidisciplinary care subscale and a patient-centered care subscale.Results:Multiple regression analysis revealed that the multidisciplinary care subscale was significantly related to implementation of patient-based medical record system that was paper-based (p<0.05). The results of the secondary analysis showed a significant relationship between the interdepartmental medical record system and the patient’s perception of multidisciplinary care (p<0.05) and patient-centered care (p<0.05). When a multidisciplinary case conference took place regularly or multidisciplinary viewpoints were incorporated into the conference records, the conference had a significantly higher correlation with both subscales (p<0.001).Conclusions:Integrated patient-based information and regular multidisciplinary case conferences that include records of viewpoints from different professionals improve patients’ perceptions of comprehensive breast cancer care.

Results suggest that the stress management program has the potential to boost perimenopausal women's ability to cope with stress and improve their psychological well-being.

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