Effectiveness of a brief manualized intervention, Managing Cancer and Living Meaningfully (CALM), adapted to the Italian cancer care setting: Study protocol for a single-blinded randomized controlled trial

Abstract

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.

Mental state of demoralisation across diverse clinical settings: A systematic review, meta-analysis and proposal for its use as a ‘specifier’ in mental illness

“…In addition to cognitively oriented and existential therapies, meaning-centred therapy has been identified as a targeted treatment for demoralisation (Kissane, 2017). The semi-structured intervention, 'Managing Cancer and Living Meaningfully' (Nissim et al, 2012), has shown a moderate effect size in ameliorating demoralisation in patients with high baseline death anxiety (Caruso et al, 2020;Rodin et al, 2018). Additionally, logotherapy, a therapy developed based on individuating life and existential meaning, has been demonstrated to be effective in the reduction of demoralisation in breast and gynaecological cancer patients (Sun et al, 2021).…”

Systematic Review of Interventions for Demoralization in Patients With Cancer

“…They are both designed to help patients with cancer continue to find meaning in their lives after their illness and to maintain a sense of meaning at the end of life. CALM therapy, a semistructured, individualized, manualized psychological intervention, is specifically designed for patients with advanced cancer to reduce their suffering and increase their sense of well-being (Caruso et al, 2020a). CALM therapy can be understood simply as a combination of meaning-centered psychotherapy and active symptom management and has commonalities with meaning therapy (Lo et al, 2015).…”

“…Active research on CALM has been conducted in several countries. However, unfortunately, most of the published articles on CALM are protocol studies (Caruso et al, 2020a; Lo et al, 2015), which do not allow access to the effect of CALM interventions on demoralization. Moreover, some national CALM protocols do not include demoralization as a measure (Caruso et al, 2020b).…”

Feasibility of online managing cancer and living meaningfully (CALM) in Chinese patients with metastatic breast cancer: a pilot randomized control trial

“…As a pilot trial, the key objectives were to examine the feasibility of implementing the online CALM therapy in Chinese patients with metastatic breast cancer, while also allowing pilot test of potential treatment effects. Thus, a smaller sample size was selected similar as a former pilot study 23 . Mean difference (D) and standard deviation (SD) of efficacy evaluation results were often used as parameters for sample size calculations in randomized controlled studies.…”