Feasibility of CALM Therapy in Korean Cancer Patients (CALM_Korea)

January 12, 2026 updated by: Jungmin Woo, Kyungpook National University Hospital

Feasibility and Preliminary Effectiveness of 'Managing Cancer and Living Meaningfully'

This feasibility study examined the cultural adaptation and implementation of Managing Cancer and Living Meaningfully (CALM) therapy for advanced cancer patients in Korea. CALM is a brief manualized individual psychotherapy designed to address psychological distress and existential concerns in patients with advanced disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This single-arm feasibility study evaluated the acceptability, tolerability, and preliminary effectiveness of CALM therapy in the Korean cultural and healthcare context. Patients with advanced or metastatic solid-tumor cancers received 3-6 individual therapy sessions over 3-6 months, delivered by trained psychiatrists.

The study assessed feasibility through recruitment rates, therapy completion rates, and outcome measure completion. A mixed-methods approach included quantitative outcome measures (depression, death anxiety, attachment, quality of life, anxiety) and qualitative interviews with patients and caregivers to evaluate implementation barriers and facilitators.

This study was conducted in collaboration with the developers of CALM therapy at Princess Margaret Cancer Centre, Toronto, Canada. Therapists were trained through the international CALM training program, including workshop attendance and supervised training cases under the supervision of the intervention developers.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
      • Daegu, South Korea, 41944
        • Kyungpook National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥19 years
  • Fluent in Korean
  • Able to provide informed consent

  • Diagnosis of advanced or metastatic solid-tumor cancer, including:

    • Stage III or IV lung or ovarian cancer
    • Any stage of pancreatic cancer
    • Stage IV gastrointestinal, gynecological, breast, genitourinary, sarcoma, melanoma, or endocrine cancer
    • Unresectable cholangiocarcinoma, liver, ampullary, or peri-ampullary cancer

Exclusion Criteria:

  • Major communication difficulties
  • Inability to commit to 3-6 psychotherapy sessions (e.g., too ill to participate, lack of transportation, insufficient motivation)
  • Cognitive impairment as indicated by clinical team or patient chart

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CALM Therapy
Participants receive 3-6 individual CALM therapy sessions over 3-6 months
Behavioral: Managing Cancer and Living Meaningfully (CALM)

CALM (Managing Cancer and Living Meaningfully) is a semi-structured, manualized individual psychotherapy designed for patients with advanced cancer, grounded in relational, attachment, and existential theory.

CALM consists of 3-6 individual sessions (45-60 minutes each) delivered over 3-6 months by specially trained therapists. The therapy addresses four core domains: (1) symptom management and communication with healthcare providers; (2) changes in self and relations with close others; (3) sense of meaning and purpose; and (4) the future and mortality. All domains are addressed with each patient, with sequencing and emphasis tailored to individual concerns.

Patients' caregivers or family members are encouraged to participate in sessions as appropriate. CALM can be delivered by trained therapists from various disciplines including psychiatry, psychology, social work, nursing, and medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Recruitment Rate
Time Frame: 2 years (June 2019 - June 2021)
Recruitment of at least 51 patients over 2 years
2 years (June 2019 - June 2021)
Feasibility: Outcome Measure Completion Rate
Time Frame: Through study completion, up to 6 months per participant
At least 66% of patients complete the outcome measures at least 50% of the time
Through study completion, up to 6 months per participant
Feasibility: Therapy Completion Rate
Time Frame: Through study completion, up to 6 months per participant
At least 50% of patients complete at least 3 CALM sessions
Through study completion, up to 6 months per participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Symptoms (PHQ-9)
Time Frame: Baseline, 3 months, and 6 months
Patient Health Questionnaire-9, a 9-item measure of depression. Scores range 0-27, with higher scores indicating more severe depressive symptoms.
Baseline, 3 months, and 6 months
Death-Related Distress (DADDS)
Time Frame: Baseline, 3 months, and 6 months
Death and Dying Distress Scale, a validated 15-item scale measuring death anxiety in advanced cancer patients, addressing fears about the dying process and distress about lost opportunities and self-perceived burden.
Baseline, 3 months, and 6 months
Attachment Security (ECR-M16)
Time Frame: Baseline, 3 months, and 6 months
Modified and brief Experiences in Close Relationships scale, a 16-item measure of attachment security assessing attachment anxiety (fear of abandonment) and avoidance (defensive independence). Lower scores indicate greater attachment security.
Baseline, 3 months, and 6 months
Quality of Life (QUAL-EC)
Time Frame: Baseline, 3 months, and 6 months
Quality of Life at the End of Life-Cancer Scale, measuring quality of life in patients near end of life. Includes 4 subscales: Symptom Impact, Preparation for End-of-Life, Relationship with Healthcare Providers, and Life Completion.
Baseline, 3 months, and 6 months
Treatment Evaluation (CEQ)
Time Frame: 3 months and 6 months
Modified Clinical Evaluation Questionnaire, a 15-item measure (7 original + 8 added items) evaluating the extent to which patients felt supported by their CALM therapist and how CALM therapy helps patients cope with the future, discuss important things with loved ones, and increase double awareness.
3 months and 6 months
Generalized Anxiety (GAD-7)
Time Frame: Baseline, 3 months, and 6 months
Generalized Anxiety Disorder-7, a 7-item measure of anxiety symptoms. Scores range 0-21, with higher scores indicating more severe anxiety.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyungpook National University Hospital

Collaborators

University Health Network, Toronto
Kyungpook National University Chilgok Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Actual)

June 12, 2021

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KNUH 2019-05-028
  • KNUCH 2019-04-026-001 (Other Identifier: Kyungpook National University Chilgok Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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