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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040032
Receipt No. 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 2020/06/09

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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 Patient characteristics, 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
Email 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
Email semiyamoto-nhn@umin.org

Sponsor
Institute The University Tokyo Hospital
Institute
Department

Funding Source
Organization The University Tokyo Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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
Email 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

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
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 30 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

Management information
Registered date
2020 Year 04 Month 02 Day
Last modified on
2020 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045591

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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