Caruso Rosangela, Nanni Maria Giulia, Rodin Gary, Hales Sarah, Malfitano Carmine, De Padova Silvia, Bertelli Tatiana, Murri Martino Belvederi, Bovero Andrea, Miniotti Marco, Leombruni Paolo, Zerbinati Luigi, Sabato Silvana, Grassi Luigi
Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.
University Hospital Psychiatry Unit, Program on Psycho-Oncology and Psychiatry in Palliative Care, Integrated Department of Mental Health and Addictive Disorders, Health Trust and University S. Anna Hospital, Ferrara, Italy.
Contemp Clin Trials Commun. 2020 Oct 10;20:100661. doi: 10.1016/j.conctc.2020.100661. eCollection 2020 Dec.
Patients with advanced cancer suffer from psychosocial distress that may impair quality of life and that may be ameliorated by psychotherapeutic treatment. We describe here the methodology of a randomized controlled trial (RCT) to assess the effectiveness of a novel, brief, semi-structured psychotherapeutic intervention to reduce distress and increase well-being in patients with advanced or metastatic cancer. The intervention, called Managing Cancer and Living Meaningfully (CALM), was originally developed in Canada and we are now testing its Italian adaptation (CALM-IT). The study is a single-blinded phase III RCT with assessment at baseline, 3 and 6 months with two conditions: CALM-IT versus a nonspecific supportive intervention (SPI). Eligibility criteria include: ≥ 18 years of age; fluency in the Italian language; no cognitive deficit, and diagnosis of advanced or metastatic cancer with an expected survival of 12-18 months. CALM-IT includes up to 12 sessions, delivered over 6 months and covers 4 domains: i) Symptom Management and Communication with Health Care Providers; ii) Changes in Self and Relations with Close Others; iii) Sense of Meaning and Purpose; and iv) the Future and Mortality. The primary outcome is difference in severity of depressive symptoms between treatment arm and the primary endpoint is 6 months. The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, attachment security, posttraumatic growth, communication with partners, quality of life, and satisfaction with clinical care. If shown to be effective, CALM-IT can be implemented nationally to relieve distress and to promote psychological well-being in patients with advanced cancer.
晚期癌症患者会遭受心理社会困扰，这可能会损害生活质量，而心理治疗可能会改善这种情况。我们在此描述一项随机对照试验（RCT）的方法，以评估一种新型、简短、半结构化心理治疗干预措施对减轻晚期或转移性癌症患者的困扰并提高其幸福感的有效性。这种干预措施名为“有意义地管理癌症与生活”（CALM），最初在加拿大开发，我们现在正在测试其意大利语版本（CALM-IT）。该研究是一项单盲III期RCT，在基线、3个月和6个月时进行评估，分为两种情况：CALM-IT与非特异性支持性干预（SPI）。纳入标准包括：年龄≥18岁；意大利语流利；无认知缺陷，以及诊断为晚期或转移性癌症，预期生存期为12 - 18个月。CALM-IT包括最多12次疗程，在6个月内完成，涵盖4个领域：i）症状管理与与医疗保健提供者的沟通；ii）自我变化以及与亲密他人的关系；iii）意义和目的感；iv）未来与死亡。主要结局是治疗组之间抑郁症状严重程度的差异，主要终点是6个月。次要终点是3个月，次要结局包括：广泛性焦虑、对死亡的困扰、士气低落、精神幸福感、依恋安全性、创伤后成长、与伴侣的沟通、生活质量以及对临床护理的满意度。如果证明有效，CALM-IT可在全国范围内实施，以缓解晚期癌症患者的困扰并促进其心理健康。
