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 2023/04/07 16:00:07

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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

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 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

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

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

2023 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name