UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031889
Receipt number R000036406
Scientific Title Prospective study on chemical coping
Date of disclosure of the study information 2018/03/25
Last modified on 2019/09/29 14:56:45

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Basic information

Public title

Prospective study on chemical coping

Acronym

Prospective study on chemical coping

Scientific Title

Prospective study on chemical coping

Scientific Title:Acronym

Prospective study on chemical coping

Region

Japan


Condition

Condition

Patients receiving palliative care

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Psychosomatic Internal Medicine Infectious disease
Geriatrics Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Endocrine surgery Breast surgery Obstetrics and Gynecology
Dermatology Psychiatry Oto-rhino-laryngology
Orthopedics Urology Radiology
Anesthesiology Oral surgery Neurosurgery
Cardiovascular surgery Emergency medicine Dental medicine
Nursing Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Prospectively consider the frequency and risk factor of chemical coping.

Basic objectives2

Others

Basic objectives -Others

Prospectively consider percentage to shift to opioid dependence in patient with chemical coping.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the frequency and risk factor of chemical coping (CC)

Key secondary outcomes

Percentage to shift to opioid dependence


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1,All patients undergoing intervention by the Palliative Medical Department at the time of this study registration.
2,Patients over 20 years old

Key exclusion criteria

1,Patients judged to be unable to receive interview.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Takaomi
Middle name
Last name Kessoku

Organization

Yokohama city university hospotal

Division name

Palliative care

Zip code

236-0004

Address

3-9, Fukuura, Kanazawa-ku

TEL

0457872640

Email

takaomi0027@gmail.com


Public contact

Name of contact person

1st name Takaomi
Middle name
Last name Kessoku

Organization

Yokohama city university

Division name

Palliative care center

Zip code

236-0004

Address

3-9, Fukuura, Kanazawaku

TEL

0457872640

Homepage URL


Email

takaomi0027@gmail.com


Sponsor or person

Institute

Yokohama city university

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yokohama city university

Address

3-9, Fukuura, Kanazawa-ku, Yokohama city, Kanagawa

Tel

0457872640

Email

takaomi0027@gmail.com


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

2018 Year 03 Month 25 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

Open public recruiting

Date of protocol fixation

2016 Year 11 Month 03 Day

Date of IRB

2017 Year 11 Month 03 Day

Anticipated trial start date

2017 Year 11 Month 03 Day

Last follow-up date

2022 Year 11 Month 02 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2018 Year 03 Month 25 Day

Last modified on

2019 Year 09 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036406


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name