CALM Psychotherapy in Patients With Metastatic Cancer in Chile

Not Applicable

Recruiting

• Conditions: Metastatic Cancer
• Interventions: Behavioral: CALM psychotherapy

• Registration Number: NCT06501261
• Lead Sponsor: Fundacion Arturo Lopez Perez

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.

Study Timeline

• Study Start: 2022-10-14
• Study First Submitted: 2023-01-17
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CALM arm	CALM psychotherapy	patients receiving CALM sessions

Primary Outcome Measures

Name	Time	Method
depressive symptoms	6 months	Patient Health Questionnaire 9- Higher score means higher depression
Death anxiety	6 months	Death and Dying Distress Scale- Higher score means higher depression

Trial Locations

Locations (1)

Fundacion Arturo Lopez Perez; 🇨🇱 Providencia, Santiago, Chile