Preliminary Efficacy and Acceptability of CALM Psychotherapy in Chile
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metastatic Cancer
- Sponsor
- Fundacion Arturo Lopez Perez
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- depressive symptoms
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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. Sample size 34 participants. Sessions will be online, 45 to 50 minutes long. Sessions can be recorded for supervision and training purposes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •significant verbal communication difficulties;
- •cognitive impairment indicated by the clinical team or in the patient's file.
- •Patients currently in psychotherapy.
- •Active suicidal ideation
Outcomes
Primary Outcomes
depressive symptoms
Time Frame: 6 months
Patient Health Questionnaire 9- Higher score means higher depression
Death anxiety
Time Frame: 6 months
Death and Dying Distress Scale- Higher score means higher depression