L care alone. In the Princess Margaret Cancer Centre this includes routine remedy and follow-up in healthcare, surgical andor radiation outpatient oncology clinics, together with a clinic-based distress screening program, known as DART (Distress Assessment and Response Tool) [35], with final results offered in the time of your clinic take a look at to oncology clinic staff. Clinic employees could refer any patient for specialized psychosocial oncology services (offered by educated volunteers and by social work, psychiatry and psychology employees) or to palliative care, primarily based on clinical judgment, patient requests andor distress screening scores. In the event that a usual care participant reports suicidal intent, the principal investigators are contacted along with the patient is assessed by a psychiatrist from the Division of Phillygenin chemical information supportive Care. Around one third of individuals with metastatic cancer are referred PubMed ID:http://www.ncbi.nlm.nih.gov/pubmed/2129593 for psychosocial care at the Princess Margaret, two thirds of whom are seen by a social worker [36]. About 65 of social perform 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 sufferers 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 one particular third receive a structured or semi-structured psychotherapy. Overall, less than 10 of patients with metastatic cancer in the Princess Margaret Cancer Centre receive any form of semi-structured psychotherapy that is similar to CALM therapy. To avoid contamination of your control group inside the event of a referral to the Department of Supportive Care, controls referred for psychosocial care will be seen, if possible, by therapists within the department 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 in 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 treatment 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 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 Department of Biostatistics in the Princess Margaret Cancer Centre, which is independent of 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 individuals [38]. This brief measure is a subscale from the Patient Health Questionnaire (PHQ), a patient self-report version in the Primary Care Evaluation of Mental Disorders (PRIME-MD), a widely used tool to screen for mental health.