UMIN-CTR Clinical Trial

Basic information
Public title	Japan PHarmacological Audit study of Safety and Efficacy in Real world
Acronym	Phase-R
Scientific Title	Japan PHarmacological Audit study of Safety and Efficacy in Real world
Scientific Title:Acronym	Phase-R
Region	Japan

Condition
Condition	Cancer
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the efficacy and safety of symptom management procedures in palliative care setting.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	patient-reported symptom severity
Key secondary outcomes	1) proxy-rated symptom severity 2) adverse event

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with pathologically or clinically diagnosed cancer 2) In- and out-patients receiving palliative care by palliative care team or at palliative care unit
Key exclusion criteria	none
Target sample size	850

Research contact person
Name of lead principal investigator	1st name Isseki Middle name Last name Maeda
Organization	Osaka University Graduate School of Medicine
Division name	Department of Palliative Medicine
Zip code	565-0871
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3867
Email	maeda@pm.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Chieko Middle name Last name Suzuki
Organization	Seirei Mikatahara Hospital
Division name	Palliative and Supportive care Division
Zip code	433-8558
Address	3453 Mikatahara, Kita, Hamamatsu, Shizuoka
TEL	053-436-1251
Homepage URL
Email	jmmorita@sis.seirei.or.jp

Sponsor
Institute	Department of Palliative Medicine, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japan Hospice Palliative Care Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Osaka University Graduate School of Medicine
Address	2-2 Yamadaoka, Suita, Japan
Tel	06-6879-3867
Email	maeda@pm.med.osaka-u.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

大阪大学大学院（大阪府） 聖隷浜松病院（静岡県） 聖隷三方原病院（静岡県） 佐久総合病院（長野県） 独立行政法人　国立がん研究センター東病院（千葉県） 三井記念病院（東京都） 川崎市立井田病院かわさき総合ケアセンター（神奈川県） 筑波メディカルセンター病院（茨城県） ガラシア病院（大阪府） 六甲病院（兵庫県） 九州がんセンター（福岡県） 国立病院機構　近畿中央胸部疾患センター（大阪府） 神戸大学大学院（兵庫県） 島根大学医学部附属病院（島根県） 小牧市民病院（愛知県） 聖路加国際病院（東京都） 東京大学医学部附属病院（東京都） 東京大学医科学研究所附属病院（東京都） 名古屋市立大学大学院（愛知県） 岡山大学病院（岡山県） 国立がん研究センター中央病院（東京都） 千葉県がんセンター（千葉県） 埼玉県立がんセンター（埼玉県） 東京医科歯科大学大学院医歯学総合研究科（東京都） 埼玉医大国際医療センター（埼玉県） 福山市民病院（広島県） 滋賀医科大学（滋賀県） 市立札幌病院（北海道） 相良病院（鹿児島県） 栃木県立がんセンター（栃木県） 近畿大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2014 Year 03 Month 04 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	Completed
Date of protocol fixation	2013 Year 10 Month 03 Day
Date of IRB	2014 Year 02 Month 01 Day
Anticipated trial start date	2014 Year 02 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1) patient-reported symptom severity 2) proxy-rated symptom severity 3) adverse event

Management information
Registered date	2014 Year 03 Month 04 Day
Last modified on	2021 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013962