About this trial
Patients with metastatic cancer experience multidimensional challenges that increase the risk of emotional distress, which must be addressed by the health team. Chile lacks evidence on effective therapeutic interventions in this population. CALM is a brief, individual (with the presence of a caregiver in one or more sessions) and evidence-based psychotherapy developed at The Princess Margaret Cancer Center. It consists of an intervention of 3 to 6 psychotherapy sessions over a period of 3 to 6 months. The Global CALM program aims to expand CALM research around the world, a program to which FALP has subscribed. Objective: To evaluate the preliminary efficacy of CALM in a sample of patients with metastatic cancer in Chile.
Phase 2 study of preliminary, pseudo-experimental efficacy, without a control group. The study will be carried out in Falp and Corporación Valientes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
be ≥18 years of age;
be fluent in Spanish;
be able to give informed consent; and
have received a diagnosis of advanced or metastatic solid tumor cancer with a reduced life expectancy but greater than six months.
Disqualifiers
significant verbal communication difficulties;
cognitive impairment indicated by the clinical team or in the patient's file.
Patients currently in psychotherapy.
Active suicidal ideation
Trial design
Single group
Treatments tested in this trial
CALM psychotherapy
Behavioralpsychotherapy sessions
Treatment groups
Trial outcomes
Primary outcomes
depressive symptoms
Patient Health Questionnaire 9- Higher score means higher depression
depressive symptoms
Patient Health Questionnaire 9- Higher score means higher depression
Death anxiety
Death and Dying Distress Scale- Higher score means higher depression
Death anxiety
Death and Dying Distress Scale- Higher score means higher depression
Sponsors and contacts
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Fundacion Arturo Lopez Perez
Lead sponsor
University of Toronto
Collaborator