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CompletedNCT07355153CALM_KoreaUpdated Jan 21, 2026

Feasibility of CALM Therapy in Korean Cancer Patients

An interventional study of Managing Cancer and Living Meaningfully (CALM) in Depression, sponsored by Kyungpook National University Hospital. Completed at 2 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Kyungpook National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Depression

Keywords

  • Quality of life
  • Depression
  • Cancer
  • Psychotherapy
  • Behavioral symptoms
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    CALM Therapy

    Participants receive 3-6 individual CALM therapy sessions over 3-6 months

    Behavioral: Managing Cancer and Living Meaningfully (CALM)

Interventions

  • BehavioralManaging 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.

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What researchers measure

Primary outcomes

  1. Feasibility: Recruitment Rate

    Recruitment of at least 51 patients over 2 years

    Time frame: 2 years (June 2019 - June 2021)

  2. Feasibility: Outcome Measure Completion Rate

    At least 66% of patients complete the outcome measures at least 50% of the time

    Time frame: Through study completion, up to 6 months per participant

  3. Feasibility: Therapy Completion Rate

    At least 50% of patients complete at least 3 CALM sessions

    Time frame: Through study completion, up to 6 months per participant

Secondary outcomes

  1. Depression Symptoms (PHQ-9)

    Patient Health Questionnaire-9, a 9-item measure of depression. Scores range 0-27, with higher scores indicating more severe depressive symptoms.

    Time frame: Baseline, 3 months, and 6 months

  2. Death-Related Distress (DADDS)

    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.

    Time frame: Baseline, 3 months, and 6 months

  3. Attachment Security (ECR-M16)

    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.

    Time frame: Baseline, 3 months, and 6 months

  4. Quality of Life (QUAL-EC)

    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.

    Time frame: Baseline, 3 months, and 6 months

  5. Treatment Evaluation (CEQ)

    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.

    Time frame: 3 months and 6 months

  6. Generalized Anxiety (GAD-7)

    Generalized Anxiety Disorder-7, a 7-item measure of anxiety symptoms. Scores range 0-21, with higher scores indicating more severe anxiety.

    Time frame: Baseline, 3 months, and 6 months

06

Study locations

2 sites
  • Kyungpook National University Chilgok Hospital
    Daegu, 41404, South Korea
  • Kyungpook National University Hospital
    Daegu, 41944, South Korea
07

References and documents

Publications

  • Rodin G, Lo C, Rydall A, Shnall J, Malfitano C, Chiu A, Panday T, Watt S, An E, Nissim R, Li M, Zimmermann C, Hales S. Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer. J Clin Oncol. 2018 Aug 10;36(23):2422-2432. doi: 10.1200/JCO.2017.77.1097. Epub 2018 Jun 29. PubMed 29958037 ↗

Individual participant data

Plan to share: Yes

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Registry details

Key details

Study ID
NCT07355153
Lead sponsor
Kyungpook National University Hospital
Collaborators
Kyungpook National University Chilgok Hospital, University Health Network, Toronto
Responsible party
Jungmin Woo (Professor, Kyungpook National University Hospital) — Principal investigator
First posted
Jan 21, 2026
Start date
Jun 12, 2019
Primary completion
Jun 12, 2021
Completion
Dec 31, 2024
Last update
Jan 21, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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