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An examination of the feasibility and preliminary effectiveness of Managing Cancer And Living Meaningfully (CALM) in Japanese cancer patients

Managing Cancer And Living Meaningfully (CALM) in Japanese cancer patients: Phase 2 trial - CALM-J

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040032
Enrollment
46
Registered
2020-06-30
Start date
2020-04-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stage III or IV lung cancer, any-stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer or other stage IV gastrointestinal cancer, stage III or IV ovarian and fallopian tube cancers or other stage IV gynecologic cancer, stage IV breast cancer, genitourinary cancer, sarcoma, melanoma, or endocrine cancer.

Interventions

Participants and therapists will have 3-6 individual therapy sessions, each approximately 45-60 minutes in length, delivered over 3-6 months (the number of sessions may vary, depending on the clinical

Sponsors

The University Tokyo Hospital
Lead Sponsor
the Cancer Institute Hospital of Japanese Foundation for Cancer Research, and Yamaguchi University Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The following inclusion criteria must be fulfilled among outpatients who will receive CALM therapy as their usual treatment. 1.Aged 18 and over 2.be fluent in spoken Japanese 3.be able to provide informed consent 4.have received a diagnosis of stage III or IV lung cancer, any-stage pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary or peri-ampullary cancer or other stage IV gastrointestinal cancer, stage III or IV ovarian and fallopian tube cancers or other stage IV gynecologic cancer, stage IV breast cancer, genitourinary cancer, sarcoma, melanoma, or endocrine cancer, and have an understanding of their diagnosis. 5.Expected survival is 6 months or more.

Exclusion criteria

Exclusion criteria: 1.Major communication difficulties with therapist 2.Inability to commit to the required 3-6 psychotherapy sessions, for example, too ill to participate, lack of transportation, insufficient motivation to participate, etc. 3.Cognitive impairment as indicated by the clinical team or in the patient's chart 4.Cases in which the therapist indicates pharmacotherapy as a priority treatment for the patient during the first interview.

Design outcomes

Primary

MeasureTime frame
Improvement rate of depressive symptoms using the PHQ-9 and completion rate

Secondary

MeasureTime frame
The Quality of Life at the End of Life-Cancer Scale (QUAL-EC), The Death and Dying Distress Scale (DADDS), Experiences in Close Relationships (ECR-M16), The Clinical Evaluation Questionnaire (CEQ)

Countries

Japan

Contacts

Public ContactSeraki Miyamoto

The University Tokyo Hospital Department of Psychosomatic Medicine

semiyamoto-nhn@umin.org03-5800-9764

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026