Depression
Conditions
Keywords
Quality of life, Depression, Cancer, Psychotherapy, Behavioral symptoms
Brief 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.
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.
Interventions
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.
Sponsors
Kyungpook National University Hospital
Kyungpook National University Chilgok Hospital
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm feasibility study with mixed-methods evaluation
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Therapy Completion Rate | Through study completion, up to 6 months per participant | At least 50% of patients complete at least 3 CALM sessions |
| Feasibility: Recruitment Rate | 2 years (June 2019 - June 2021) | Recruitment of at least 51 patients over 2 years |
| Feasibility: Outcome Measure Completion Rate | Through study completion, up to 6 months per participant | At least 66% of patients complete the outcome measures at least 50% of the time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (QUAL-EC) | 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. |
| Treatment Evaluation (CEQ) | 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. |
| Depression Symptoms (PHQ-9) | 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. |
| Generalized Anxiety (GAD-7) | 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. |
| Death-Related Distress (DADDS) | 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. |
| Attachment Security (ECR-M16) | 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. |
Countries
South Korea
Outcome results
None listed