NCT07355153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 12, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2021

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

Depression

Keywords

Quality of lifeDepressionCancerPsychotherapyBehavioral symptoms

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (6)

  • Depression Symptoms (PHQ-9)

    Baseline, 3 months, and 6 months

  • Death-Related Distress (DADDS)

    Baseline, 3 months, and 6 months

  • Attachment Security (ECR-M16)

    Baseline, 3 months, and 6 months

  • Quality of Life (QUAL-EC)

    Baseline, 3 months, and 6 months

  • Treatment Evaluation (CEQ)

    3 months and 6 months

  • +1 more secondary outcomes

Study Arms (1)

CALM Therapy

EXPERIMENTAL

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

Behavioral: Managing Cancer and Living Meaningfully (CALM)

Interventions

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.

CALM Therapy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 29958037RESULT

MeSH Terms

Conditions

DepressionNeoplasmsBehavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-arm feasibility study with mixed-methods evaluation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start

June 12, 2019

Primary Completion

June 12, 2021

Study Completion

December 31, 2024

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations

KR(2)