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NCT Number: NCT06501261

CALM Psychotherapy in Patients With Metastatic Cancer in Chile

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion Arturo Lopez Perez

Providencia, Santiago Metropolitan, 7500921, Chile

Location status: Recruiting

Location contact

Christian Caglevic, md

CONTACT

[email protected]

2 2420 5100

Loreto Fernandez-Gonzalez, PhD(c)

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CALM psychotherapy

Behavioral

psychotherapy sessions

Primary outcomes

  1. depressive symptoms

    Time frame: 3 months

    Patient Health Questionnaire 9- Higher score means higher depression

  2. depressive symptoms

    Time frame: 6 months

    Patient Health Questionnaire 9- Higher score means higher depression

  3. Death anxiety

    Time frame: 3 months

    Death and Dying Distress Scale- Higher score means higher depression

  4. Death anxiety

    Time frame: 6 months

    Death and Dying Distress Scale- Higher score means higher depression

Sponsors and collaborators

Lead sponsor

Fundacion Arturo Lopez Perez

Other

Collaborators

  • University of Toronto

Registry information

Official study title

Preliminary Efficacy and Acceptability of CALM Psychotherapy in Chile

Acronym: CALM-Ch

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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