• Rosangela Caruso, Maria Giulia Nanni, Gary Rodin, Sarah Hales, Carmine Malfitano, Silvia De Padova, Tatiana Bertelli, Martino Belvederi Murri, Andrea Bovero, Marco Miniotti, Paolo Leombruni, Luigi Zerbinati, Silvana Sabato, Luigi Grassi, and CALM-Italian Study.
• Institute of Psychiatry, Department of Biomedical and Specialty Surgical Sciences, University of Ferrara, Ferrara, Italy.
• Contemp Clin Trials Commun. 2020 Dec 1; 20: 100661.

AbstractPatients 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.© 2020 The Authors. Published by Elsevier Inc.

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