Development of a Japanese Version of the Quality of Life at the End of Life-Cancer Scale.

CONTEXT: The Quality of Life at the End of Life-Cancer Scale (QUAL-EC) is a self-reported instrument to assesses the quality of life of patients with cancer near the end of life. OBJECTIVE: To test the reliability and validity of the QUAL-EC-J, a Japanese translated version of the QUAL-EC. METHODS: A total of 179 Japanese patients with advanced cancer completed the QUAL-EC-J, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Rosenberg Self-Esteem Scale, Multidimensional Scale of Perceived Social Support, Functional Assessment of Cancer Therapy-General Scale, and Functional Assessment of Chronic Illness Therapy-Spiritual questionnaires. We performed confirmatory factor analysis of the four structures of the QUAL-EC and exploratory factor analysis of the QUAL-EC-J. Internal consistency was assessed using Cronbach's α coefficient and validity was examined by calculating correlations with relevant scales. RESULTS: Confirmatory factor analysis showed an inadequate fit to the original QUAL-EC structure. Exploratory factor analysis revealed a three-factor structure of the QUAL-EC-J, with Cronbach's α values of 0.68-0.88. All subscales were negatively correlated with depression and anxiety. Each subscale was correlated with related measures: "symptom control" with "physical well-being"; "acceptance of disease and life" with "social and family well-being" and "meaning/peace"; and "preparation for end of life" with "emotional well-being" and "meaning/peace." CONCLUSIONS: The QUAL-EC-J has a three-factor structure with acceptable reliability and sufficient validity. Differences in the factor structure between the QUAL-EC-J and the QUAL-EC may be due to cultural factors. Study findings suggest that utilization of the QUAL-EC-J could help to improve research and clinical care in advanced cancer in Japan.

Brief, manualised and semistructured individual psychotherapy programme for patients with advanced cancer in Japan: study protocol for Managing Cancer and Living Meaningfully (CALM) phase 2 trial.

INTRODUCTION: Managing Cancer and Living Meaningfully (CALM) is a novel, brief and manualised psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced cancer. This phase 2 trial aims to assess the feasibility and preliminary efficacy of CALM in Japanese patients with cancer. METHODS AND ANALYSIS: This study is a single-arm clinical trial. All patients involved in the study are ≥18 years of age, have been diagnosed with advanced or metastatic solid-tumour cancer, and their expected survival is at least 6 months. CALM comprises three to six individual therapy sessions, each lasting approximately 45-60 min, provided over 3- 6 months. The participants will be asked to complete questionnaires at baseline (t0), 3 months (t1) and 6 months (t2). The primary outcomes are rates of completion of the intervention and of the outcome measures and improvement of depressive symptoms measured using the Patient Health Questionnaire-9 between t0 and t2. The criteria for the successful rate of completion is that at least 70% participants who participate in at least three sessions will complete measures at t2. The secondary outcomes are the improvement in scores on: (1) the Quality of Life at the End of Life-Cancer Scale, (2) the Experiences in Close Relationships scale, (3) the Death and Dying Distress Scale and (4) the Clinical Evaluation Questionnaire. ETHICS AND DISSEMINATION: This study was approved by the Research Ethics Committee of The University of Tokyo, Cancer Institute Hospital of Japanese Foundation for Cancer Research and Yamaguchi University. We will conduct the study in accordance with the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects. The results of this study will be submitted for peer-reviewed publication and presentation at local, national and international scientific meetings and conferences. TRAIL REGISTRATION NUMBER: UMIN000040032; Pre-results.