NCT06501261

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 14, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2023

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

July 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

January 17, 2023

Last Update Submit

July 8, 2024

Conditions

Metastatic Cancer

Keywords

psychotherapypalliative care

Outcome Measures

Primary Outcomes (4)

  • depressive symptoms

    Patient Health Questionnaire 9- Higher score means higher depression

    3 months

  • depressive symptoms

    Patient Health Questionnaire 9- Higher score means higher depression

    6 months

  • Death anxiety

    Death and Dying Distress Scale- Higher score means higher depression

    3 months

  • Death anxiety

    Death and Dying Distress Scale- Higher score means higher depression

    6 months

Study Arms (1)

CALM arm

EXPERIMENTAL

patients receiving CALM sessions

Behavioral: CALM psychotherapy

Interventions

CALM psychotherapyBEHAVIORAL

psychotherapy sessions

CALM arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • significant verbal communication difficulties;
  • cognitive impairment indicated by the clinical team or in the patient's file.
  • Patients currently in psychotherapy.
  • Active suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion Arturo Lopez Perez

Providencia, Santiago Metropolitan, 7500921, Chile

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Loreto Fernandez-Gonzalez

    Fundacion Arturo Lopez Perez

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2023

First Posted

July 15, 2024

Study Start

October 14, 2022

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

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.

Time Frame
Session recordings will become available during scheduled supervision meetings and will only be watched once.
Access Criteria
GIPPEC faculty and team members

Locations

CL(1)