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Trial Title:
CALM Psychotherapy in Patients With Metastatic Cancer in Chile
NCT ID:
NCT06501261
Condition:
Metastatic Cancer
Conditions: Official terms:
Neoplasm Metastasis
Conditions: Keywords:
psychotherapy
palliative care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CALM psychotherapy
Description:
psychotherapy sessions
Arm group label:
CALM arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fundacion Arturo Lopez Perez
Address:
City:
Providencia
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Christian Caglevic, md
Phone:
2 2420 5100
Email:
christian.caglevic@falp.org
Investigator:
Last name:
Loreto Fernandez-Gonzalez, PhD(c)
Email:
Principal Investigator
Start date:
October 14, 2022
Completion date:
October 31, 2025
Lead sponsor:
Agency:
Fundacion Arturo Lopez Perez
Agency class:
Other
Collaborator:
Agency:
University of Toronto
Agency class:
Other
Source:
Fundacion Arturo Lopez Perez
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06501261
