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Completed

NCT Number: NCT07355153

Feasibility of CALM Therapy in Korean Cancer Patients

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kyungpook National University Chilgok Hospital, Daegu, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Managing Cancer and Living Meaningfully (CALM)

Behavioral

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.

Primary outcomes

  1. Feasibility: Recruitment Rate

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

    Recruitment of at least 51 patients over 2 years

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Collaborators

  • Kyungpook National University Chilgok Hospital
  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: CALM_Korea

Important dates

Study start
2019
Primary completion
2021
Study completion
2024
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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