SPARC 2017 MBC Challenge: Validation of CALM Therapy Model in MBC Patients in Portugal: An Intervention to Address Patients' Psychosocial Needs

Abstract

Background: Psychological distress is common in patients with metastatic cancer and the progression of disease brings multiple predictable challenges. However, there are very few cost-effective evidence-based interventions that address these specific needs of this population. CALM (Managing Cancer and Living Meaningfully) is a brief intervention model recently developed in Canada for this purpose. CALM includes 3-6 individual sessions, each approximately 45 minutes in length, delivered over 3 months, that cover 4 critical domains for this population: 1) symptom management and communication with health care providers; 2) changes in self and relations with close others; 3) spiritual well-being, or sense of meaning and purpose; 4) preparing for the future, sustaining hope and facing mortality. CALM has been successfully tested in Canada and other countries, showing significant reductions in depressive symptoms and death anxiety in therapy participants and a significant improvement in spiritual well-being over time. In Portugal there are no available short cost-effective psychotherapeutic interventions to address psychosocial needs of advanced cancer patients. Aims: (i) Translate and adapt the original CALM therapy manual for Portuguese patients with metastatic breast cancer (MBC) for its application and dissemination in Portugal and in other Portuguese speaking countries; (ii) Test the feasibility of the CALM therapy intervention in Portuguese patients with MBC; (iii) Test the effectiveness of CALM in reducing depression and other psychological distress in this population; (iv) Increase the availability of psychosocial resources to address the specific psychosocial needs of MBC patients and to reduce the current gap of psychosocial care for this population in Portugal and Portuguese speaking countries. Methods: Conduct a Phase II single-arm, intervention-only study, with assessments at baseline, 3 months and 6 months; Site Champalimaud Clinical Centre, Lisbon, PT; Primary outcome: depressive symptoms assessed by PHQ-9; Secondary outcome measures include: FACIT-Sp, measure of spiritual well-being in palliative care; Death and Dying Distress Scale (DADDS); Experiences in Close Relationships Inventory (ECR-M16); and the Clinical Evaluation Questionnaire (CEQ). We will also collect additional information including demographics and relevant medical data. We plan to recruit 35 patients over an 18-month period at the Breast Unit. Eligible participants will receive the CALM individual semistructured psychotherapy. The Canadian CALM team is closely monitoring and supporting the study. Results: In progress.