Metastatic CancerCALM-ChNCT06501261
CALM Psychotherapy in Patients With Metastatic Cancer in Chile
A study testing CALM psychotherapy in people with Metastatic Cancer, run by Fundacion Arturo Lopez Perez at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Cancer
- What is being tested?
- CALM psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChile
- Study dates
- 14 Oct 2022to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Fundacion Arturo Lopez Perez
Providencia, Santiago Metropolitan, 7500921
Christian Caglevic, md, 2 2420 5100, christian.caglevic@falp.org
Loreto Fernandez-Gonzalez, PhD(c)
About this study
Official title: 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.
Read the 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.
- Conditions
- Metastatic Cancer
- Being tested
- CALM psychotherapy
- Keywords
- psychotherapy, palliative care
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CALM psychotherapyBehavioural
psychotherapy sessions
| Study group | Role | What they receive |
|---|---|---|
| CALM arm | Experimental | patients receiving CALM sessions Receives: Behavioral: CALM psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive symptoms
Patient Health Questionnaire 9- Higher score means higher depression
Measured: 3 months
depressive symptoms
Patient Health Questionnaire 9- Higher score means higher depression
Measured: 6 months
Death anxiety
Death and Dying Distress Scale- Higher score means higher depression
Measured: 3 months
Death anxiety
Death and Dying Distress Scale- Higher score means higher depression
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start14 Oct 2022
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Arturo Lopez Perez
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Loreto Fernandez-Gonzalez, Principal investigator, Fundacion Arturo Lopez Perez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501261
- Sponsor's protocol ID
- FALP 001-2022
- Acronym
- CALM-Ch
- Status last verified
- Jul 2024
- First submitted
- 17 Jan 2023
- Last updated
- 15 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Efficacy and Acceptability of CALM Psychotherapy in Chile
- ClinicalTrials.gov ID
- NCT06501261
- Acronym / sponsor ID
- CALM-Ch / FALP 001-2022
- Conditions
- Metastatic Cancer
- Keywords
- psychotherapy, palliative care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fundacion Arturo Lopez PerezUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CALM arm | Experimental | Behavioral: CALM psychotherapypatients receiving CALM sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- significant verbal communication difficulties;
- cognitive impairment indicated by the clinical team or in the patient's file.
- Patients currently in psychotherapy.
- Active suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CALM psychotherapypsychotherapy sessions | Behavioural | CALM arm |
Primary outcome
depressive symptoms
Time frame: 3 months
Patient Health Questionnaire 9- Higher score means higher depression
depressive symptoms
Time frame: 6 months
Patient Health Questionnaire 9- Higher score means higher depression
Death anxiety
Time frame: 3 months
Death and Dying Distress Scale- Higher score means higher depression
Death anxiety
Time frame: 6 months
Death and Dying Distress Scale- Higher score means higher depression
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreto Fernandez-Gonzalez principal investigator
Fundacion Arturo Lopez Perez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CALM psychotherapy in people with Metastatic Cancer, run by Fundacion Arturo Lopez Perez at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depressive symptoms (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.