CALM Psychotherapy in Patients With Metastatic Cancer in Chile

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacion Arturo Lopez Perez

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Design model

Single group

Treatments tested in this trial

  • CALM psychotherapy

    Behavioral

    psychotherapy sessions

Treatment groups

34 Participants
are divided into 1 treatment group
Group A: CALM armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

depressive symptoms

Patient Health Questionnaire 9- Higher score means higher depression

Time frame
3 months
2

depressive symptoms

Patient Health Questionnaire 9- Higher score means higher depression

Time frame
6 months
3

Death anxiety

Death and Dying Distress Scale- Higher score means higher depression

Time frame
3 months
4

Death anxiety

Death and Dying Distress Scale- Higher score means higher depression

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Arturo Lopez Perez

Lead sponsor

University of Toronto

Collaborator