UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Japan multicenter cohort study to FIND predictors of common palliative treatments: J-FIND
Title of the study (Brief title)	J-FIND1
Region	Japan

Condition
Condition	Cancer
Classification by specialty	Hematology and clinical oncology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify the factors contributing to communication levels after morphine for refractory dyspnea
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Communication Capacity Scale
Key secondary outcomes	Death, Glasgow Coma Scale

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1 Adult 2 Advanced cancer 3 Morphine for refractory dyspnea 4 Receivinfg specialied palliative care services 5 STAS-J of 2 or more 6 ECOG PS of 3 or 4 7 CCS of 2 or less
Key exclusion criteria	1 Medical contraindication to morphine 2 Drainage of pleural effusion
Target sample size	80

Research contact person
Name of lead principal investigator	Masanori Mori
Organization	Seirei Hamamatsu General Hospital
Division name	Pallaitive Medicine
Address	2-12-12, Sumiyoshi, Naka-ku, Hamamatsu, Shizuoka
TEL	053-474-2222
Email	Masanori.Mori@sis.seirei.or.jp

Public contact
Name of contact person	Masanori Mori
Organization	Seirei Hamamatsu General Hospital
Division name	Pallaitive Medicine
Address	2-12-12, Sumiyoshi, Naka-ku, Hamamatsu, Shizuoka
TEL	053-474-2222
Homepage URL
Email	Masanori.Mori@sis.seirei.or.jp

Sponsor
Institute	Seirei Hamamatsu General Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Ministry of Health, Lavor and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立病院機構　大阪医療センター 大阪市立総合医療センター 大阪府立成人病センター 彩都友紘会病院 近畿中央胸部疾患センター 和歌山県立医科大学附属病院 兵庫県立がんセンター 社会保険神戸中央病院 六甲病院 藤井政雄記念病院 松江市立病院 岡山済生会総合病院 広島県立広島病院 福山市民病院 施設 国立病院機構　山口宇部医療センター 松山ベテル病院 九州がんセンター 国立病院機構　都城病院 医療法人倫生会三州病院 社会医療法人友愛会　南部病院

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 11 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 17 Day
Anticipated trial start date	2012 Year 08 Month 18 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Data collection completed

Management information
Registered date	2012 Year 09 Month 11 Day
Last modified on	2016 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000010433