CALM Psychotherapy in Patients With Metastatic Cancer in Chile (CALM-Ch)

Fundacion Arturo Lopez Perez

Status: Enrolling

Conditions: Metastatic Cancer

Treatments: Behavioral: CALM psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06501261

FALP 001-2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

CALM arm

Experimental group

Description:

patients receiving CALM sessions

Treatment:

Behavioral: CALM psychotherapy