UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040032 |
|---|---|
| Receipt number | R000045591 |
| Scientific Title | Managing Cancer And Living Meaningfully (CALM) in Japanese cancer patients: Phase 2 trial |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2025/04/07 16:10:07 |
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Basic information
Public title
An examination of the feasibility and preliminary effectiveness of Managing Cancer And Living Meaningfully (CALM) in Japanese cancer patients
Acronym
CALM-J
Scientific Title
Managing Cancer And Living Meaningfully (CALM) in Japanese cancer patients:
Phase 2 trial
Scientific Title:Acronym
CALM-J
Region
| Japan |
Condition
Condition
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.
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examining the feasibility and effectiveness of CALM in Japan.
Basic objectives2
Others
Basic objectives -Others
Nothing in particular
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Improvement rate of depressive symptoms using the PHQ-9 and completion rate
Key secondary outcomes
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)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
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 circumstances). Participants will be asked to complete additional questionnaires at 3 and 6 months in the session room, waiting room, or their home.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Yoshiuchi |
Organization
The University Tokyo Hospital
Division name
Department of Psychosomatic Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9764
kyoshiuc-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Seraki |
| Middle name | |
| Last name | Miyamoto |
Organization
The University Tokyo Hospital
Division name
Department of Psychosomatic Medicine
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5800-9764
Homepage URL
semiyamoto-nhn@umin.org
Sponsor or person
Institute
The University Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University Tokyo Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
the Cancer Institute Hospital of Japanese Foundation for Cancer Research, and Yamaguchi University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Research Ethics Committee of The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医学部附属病院（東京都）、がん研究会有明病院（東京都）、山口大学医学部付属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
The datasets will be available from the corresponding author on reasonable request.
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants who were recruited at the Department of Respiratory Medicine in The University of Tokyo Hospital; the outpatient clinic for Psycho-oncology at the Department of Stress Sciences and Psychosomatic Medicine in The University of Tokyo Hospital; the Department of Psycho-Oncology in the Cancer Institute Hospital of Japanese Foundation for Cancer Research; and at the Department of Neuropsychiatry in Yamaguchi University Hospital are receiving CALM intervention now. They are in the process of responding to the t2 (6 months after baseline) assessment.
Management information
Registered date
| 2020 | Year | 04 | Month | 02 | Day |
Last modified on
| 2025 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045591
