DepressionCALM_KoreaNCT07355153
Feasibility of CALM Therapy in Korean Cancer Patients
A study testing Managing Cancer and Living Meaningfully (CALM) in people with Depression, run by Kyungpook National University Hospital at 2 sites in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Managing Cancer and Living Meaningfully (CALM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 12 Jun 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Kyungpook National University Chilgok Hospital
Daegu, 41404
Kyungpook National University Hospital
Daegu, 41944
About this study
Official title: 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.
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.
- Conditions
- Depression
- Being tested
- Managing Cancer and Living Meaningfully (CALM)
- Keywords
- Quality of life, Depression, Cancer, Psychotherapy, Behavioral symptoms
- Medical subject headings
- Depression, Neoplasms, Behavioral Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Cancer and Living Meaningfully (CALM)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CALM Therapy | Experimental | Participants receive 3-6 individual CALM therapy sessions over 3-6 months Receives: Behavioral: Managing Cancer and Living Meaningfully (CALM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment Rate
Recruitment of at least 51 patients over 2 years
Measured: 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
Measured: Through study completion, up to 6 months per participant
Feasibility: Therapy Completion Rate
At least 50% of patients complete at least 3 CALM sessions
Measured: Through study completion, up to 6 months per participant
Secondary outcomes (6)
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.
Measured: Baseline, 3 months, and 6 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start12 Jun 2019
- Primary completion12 Jun 2021
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm feasibility study with mixed-methods evaluation
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, University Health Network, Toronto
- Responsible party
- Principal investigator, Jungmin Woo, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355153
- Sponsor's protocol ID
- KNUH 2019-05-028
- Other IDs
- KNUCH 2019-04-026-001
- Acronym
- CALM_Korea
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Effectiveness of 'Managing Cancer and Living Meaningfully'
- ClinicalTrials.gov ID
- NCT07355153
- Acronym / sponsor ID
- CALM_Korea / KNUH 2019-05-028
- Conditions
- Depression
- Keywords
- Quality of life, Depression, Cancer, Psychotherapy, Behavioral symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, University Health Network, Toronto
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 12 Jun 2021 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm feasibility study with mixed-methods evaluation
| Arm | Type | Receives |
|---|---|---|
| CALM Therapy | Experimental | Behavioral: Managing Cancer and Living Meaningfully (CALM)Participants receive 3-6 individual CALM therapy sessions over 3-6 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥19 years
- Fluent in Korean
- Able to provide informed consent
- Diagnosis of advanced or metastatic solid-tumor cancer, including:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CALM Therapy |
Primary outcome
Feasibility: Recruitment Rate
Time frame: 2 years (June 2019 - June 2021)
Recruitment of at least 51 patients over 2 years
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
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
6 secondary outcomes
Depression Symptoms (PHQ-9)
Time frame: Baseline, 3 months, and 6 months
Death-Related Distress (DADDS)
Time frame: Baseline, 3 months, and 6 months
Attachment Security (ECR-M16)
Time frame: Baseline, 3 months, and 6 months
Quality of Life (QUAL-EC)
Time frame: Baseline, 3 months, and 6 months
Treatment Evaluation (CEQ)
Time frame: 3 months and 6 months
Generalized Anxiety (GAD-7)
Time frame: Baseline, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 29958037Rodin 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Cancer and Living Meaningfully (CALM) in people with Depression, run by Kyungpook National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment Rate (time frame: 2 years (June 2019 - June 2021)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07355153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.