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CALM Psychotherapy in Patients With Metastatic Cancer in Chile

Preliminary Efficacy and Acceptability of CALM Psychotherapy in Chile

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06501261
Acronym
CALM-Ch
Enrollment
34
Registered
2024-07-15
Start date
2022-10-14
Completion date
2025-10-31
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Cancer

Keywords

psychotherapy, palliative care

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.

Interventions

BEHAVIORALCALM psychotherapy

psychotherapy sessions

Sponsors

University of Toronto
CollaboratorOTHER
Fundacion Arturo Lopez Perez
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
depressive symptoms3 monthsPatient Health Questionnaire 9- Higher score means higher depression
Death anxiety3 monthsDeath and Dying Distress Scale- Higher score means higher depression

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026