L care alone. At the Princess Margaret Cancer Centre this includes routine remedy and follow-up in health-related, surgical andor radiation outpatient oncology clinics, in addition to a clinic-based distress screening plan, referred to as DART (Distress Assessment and Response Tool) [35], with benefits supplied in the time on the clinic take a look at to oncology clinic staff. Clinic employees may well refer any patient for specialized psychosocial oncology services (supplied by educated volunteers and by social operate, psychiatry and psychology employees) or to palliative care, primarily based on clinical judgment, patient requests andor distress screening scores. Within the event that a usual care participant reports suicidal intent, the principal investigators are contacted as well as the patient is assessed by a psychiatrist from the Department of Supportive Care. About a single third of sufferers with metastatic cancer are referred PubMed ID:http://www.ncbi.nlm.nih.gov/pubmed/2129593 for psychosocial care in the Princess Margaret, two thirds of whom are seen by a social worker [36]. Around 65 of social operate consultations involve provision of practical or instrumental care (e.g., urgent drug coverage, referral for admission to the Acute Palliative Care Unit, complex continuing care placement, etc.); 35 of consultations involve brief supportive interactions to alleviate emotional distress in patients andor family members. Control participants do not typically receive structured counseling from social perform as part of usual care. Of those referred to psychiatry or psychology, less than a single third receive a structured or semi-structured psychotherapy. Overall, less than 10 of individuals with metastatic cancer at the Princess Margaret Cancer Centre receive any form of semi-structured psychotherapy that is similar to CALM therapy. To avoid contamination of the control group in the event of a referral to the Division of Supportive Care, controls referred for psychosocial care will be seen, if possible, by therapists within the division who have not received prior training in CALM therapy (i.e., non-CALM-trained therapists). Contamination will be monitored and documented and is defined as having two or more sessions with a CALM-trained therapist.Lo et al. Trials (2015) 16:Page 4 ofTreatment integrityThe therapy integrity with the intervention arm is ensured by means of weekly group supervision of therapists with case presentations. CALM sessions are audio-recorded, and therapists document sessions in a written report. Senior clinicians (GR, SH) assess overall and topic-specific competencies using remedy integrity rating scales adapted from Spiegel and Spira’s [18] tools. Evaluations are discussed with each therapist to improve competencies.RandomizationPermuted block randomization is used to allocate participants to a trial condition with order A-804598 Stratification by PHQ-9 score ( or 10). Stratification ensures that highly depressed individuals will be balanced in both arms. The randomization process is managed by the Division of Biostatistics in the Princess Margaret Cancer Centre, which is independent on the trial team.Outcome measuresThe primary outcome measure is the Patient Health Questionnaire-9 (PHQ-9) [37], a reliable and valid 9item measure of depression that has been used widely with advanced cancer sufferers [38]. This brief measure is a subscale of your Patient Health Questionnaire (PHQ), a patient self-report version from the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used tool to screen for mental health.