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

July 8, 2024 updated by: Fundacion Arturo Lopez Perez

Preliminary Efficacy and Acceptability of CALM Psychotherapy 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Santiago
      • Providencia, Santiago, Chile, 7500921
        • Recruiting
        • Fundacion Arturo Lopez Perez
        • Contact:
        • Principal Investigator:
          • Loreto Fernandez-Gonzalez, PhD(c)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CALM arm
patients receiving CALM sessions
Behavioral: CALM psychotherapy
psychotherapy sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depressive symptoms
Time Frame: 3 months
Patient Health Questionnaire 9- Higher score means higher depression
3 months
depressive symptoms
Time Frame: 6 months
Patient Health Questionnaire 9- Higher score means higher depression
6 months
Death anxiety
Time Frame: 3 months
Death and Dying Distress Scale- Higher score means higher depression
3 months
Death anxiety
Time Frame: 6 months
Death and Dying Distress Scale- Higher score means higher depression
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Arturo Lopez Perez

Collaborators

University of Toronto

Investigators

  • Principal Investigator: Loreto Fernandez-Gonzalez, Fundacion Arturo Lopez Perez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2022

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

January 17, 2023

First Submitted That Met QC Criteria

July 8, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FALP 001-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Supervision Meetings. CALM therapists (IP, co-IP) and the co-investigator team will attend in-person or online supervision meetings offered periodically by GIPPEC and the local research team. To ensure the quality of therapy, compliance with the CALM treatment manual, and delivery of best practices (especially in a diseased population), it is vital that therapists submit audio or video recorded session excerpts. Since CALM developers are located in Toronto, Canada, case discussions and audio or video presentation will be done through online platforms (Teams or Google Meet). These online platforms use secure protocols and are already in use at GIPPEC with other Global CALM participating centers. The videos will not be stored on online platforms. The identification data of the participating patients will not be disseminated in this instance, using only the study ID.

IPD Sharing Time Frame

Session recordings will become available during scheduled supervision meetings and will only be watched once.

IPD Sharing Access Criteria

GIPPEC faculty and team members

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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