Department of Stress Sciences and Psychosomatic Medicine, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Department of Psycho-Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
BMJ Open. 2022 Mar 11;12(3):e056136. doi: 10.1136/bmjopen-2021-056136.
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.
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.
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.
UMIN000040032; Pre-results.
管理癌症和有意义地生活（CALM）是一种新颖的、简短的、手册化的心理治疗干预措施，旨在治疗和预防晚期癌症患者的抑郁和生命末期困扰。本 2 期试验旨在评估 CALM 在日本癌症患者中的可行性和初步疗效。
这是一项单臂临床试验。所有参与研究的患者年龄均≥18 岁，被诊断为晚期或转移性实体瘤癌症，预计生存期至少为 6 个月。CALM 包括三到六次个体治疗，每次持续约 45-60 分钟，在 3-6 个月内提供。参与者将被要求在基线（t0）、3 个月（t1）和 6 个月（t2）时完成问卷。主要结局是干预和结局测量的完成率，以及使用患者健康问卷-9 测量的抑郁症状在 t0 到 t2 之间的改善。完成率的成功标准是至少 70%参加至少三次治疗的参与者将在 t2 时完成测量。次要结局是生活质量末期癌症量表、亲密关系体验量表、死亡和临终困扰量表和临床评估问卷的评分改善。
本研究得到了东京大学、日本癌症研究所医院癌症基金会和山口大学研究伦理委员会的批准。我们将按照《赫尔辛基宣言》和《涉及人体的医学和健康研究伦理准则》进行研究。本研究的结果将提交同行评议发表，并在当地、国家和国际科学会议和研讨会上展示。
UMIN000040032；预结果。
