Clinical trial NCT06501261: CALM Psychotherapy in Patients With Metastatic Cancer in Chile
Official title: Preliminary Efficacy and Acceptability of CALM Psychotherapy in Chile
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Cancer
Keywords: psychotherapy
palliative care
Lead sponsor: Fundacion Arturo Lopez Perez
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2024-07-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_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.

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

Primary outcomes:
measure: depressive symptoms
timeFrame: 3 months
measure: depressive symptoms
timeFrame: 6 months
measure: Death anxiety
timeFrame: 3 months
measure: Death anxiety
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Providencia
country: Chile
facility: Fundacion Arturo Lopez Perez
state: Santiago
Study officials:
affiliation: Fundacion Arturo Lopez Perez
name: Loreto Fernandez-Gonzalez
role: PRINCIPAL_INVESTIGATOR
References: