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| ID | Type | Description | Link |
|---|---|---|---|
| KNUCH 2019-04-026-001 | Other Identifier | Kyungpook National University Chilgok Hospital |
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| Name | Class |
|---|---|
| Kyungpook National University Chilgok Hospital | OTHER |
| University Health Network, Toronto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CALM Therapy | Experimental | Participants receive 3-6 individual CALM therapy sessions over 3-6 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Recruitment Rate | Recruitment of at least 51 patients over 2 years | 2 years (June 2019 - June 2021) |
| Feasibility: Outcome Measure Completion Rate | 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 | At least 50% of patients complete at least 3 CALM sessions | Through study completion, up to 6 months per participant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months, and 6 months |
| Death-Related Distress (DADDS) |
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Inclusion Criteria:
Age ≥19 years
Fluent in Korean
Able to provide informed consent
Diagnosis of advanced or metastatic solid-tumor cancer, including:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyungpook National University Chilgok Hospital | Daegu | 41404 | South Korea | |||
| Kyungpook National University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29958037 | Result | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D009369 | Neoplasms |
| D001526 | Behavioral Symptoms |
| ID | Term |
|---|---|
| D001519 | Behavior |
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Single-arm feasibility study with mixed-methods evaluation
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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) | 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) | 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) | 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) | 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 |
| Daegu |
| 41944 |
| South Korea |