CALM Psychotherapy in Patients With Metastatic Cancer in Chile

NCT ID: NCT06501261

Last Updated: 2024-07-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2025-10-31

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.

Conditions

Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CALM arm

patients receiving CALM sessions

Group Type: EXPERIMENTAL

CALM psychotherapy

Intervention Type: BEHAVIORAL

psychotherapy sessions

Interventions

CALM psychotherapy

psychotherapy sessions

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

Fundacion Arturo Lopez Perez

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Loreto Fernandez-Gonzalez

Role: PRINCIPAL_INVESTIGATOR

Fundacion Arturo Lopez Perez

Locations

Fundacion Arturo Lopez Perez

Providencia, Santiago Metropolitan, Chile

Site Status: RECRUITING

Countries

Chile

Facility Contacts

Christian Caglevic, md

Role: primary

christian.caglevic@falp.org

2 2420 5100

Other Identifiers

FALP 001-2022

Identifier Type: -

Identifier Source: org_study_id