UMIN-CTR Clinical Trial

Basic information
Public title	Patient reported outcome of the quality of life after surgery and establishment of the feedback system: an implementary research.
Acronym	POLITE RESEARCH
Scientific Title	Patient reported outcome of the quality of life after surgery and establishment of the feedback system: an implementary research.
Scientific Title:Acronym	POLITE RESEARCH
Region	Japan

Condition
Condition	Various diseases related to Surgery
Classification by specialty	Hepato-biliary-pancreatic medicine Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Aim of this study is to elucidate utility of the QOL after surgery and build a standard platform for Health Technology Assessment (HAT).
Basic objectives2	Others
Basic objectives -Others	Assessment of the QOL
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EQ-5D-5L HADS (Hospital Anxiety Depression Scale)
Key secondary outcomes	BREAST-Q FACT-Hep FACT-C FACT-L

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	10 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients scheduled for gastrointestinal surgery, breast surgery, and respiratory surgery 2) The person or family is convinced about participating in the research and can answer the questionnaire.
Key exclusion criteria	1) Cases in which it is difficult to fill out and enter questionnaires by the person due to problems with cognitive function, etc. 2) Patients who do not own devices such as smartphones, tablets, and PCs and cannot answer ePRO (electronic questionnaire) at home 3) In addition, when the doctor in charge judges that the registration of this study is inappropriate
Target sample size	13000

Research contact person
Name of lead principal investigator	1st name MIZUGUCHI Middle name Last name TORU
Organization	SAPPORO MEDICAL UNIVERSITY
Division name	Department of Nursing, Surgical science & Technology
Zip code	0608556
Address	S1, W17, Chuo-ku, Sapporo, Hokkaido 0608556, JAPAN
TEL	0116112111
Email	tmizu@sapmed.ac.jp

Public contact
Name of contact person	1st name MIZUGUCHI Middle name Last name TORU
Organization	SAPPORO MEDICAL UNIVERSITY
Division name	Department of Nursing, Surgical science & Technology
Zip code	0608556
Address	S1, W17, Chuo-ku, Sapporo, Hokkaido 0608556, JAPAN
TEL	0116112111
Homepage URL
Email	tmizu@sapmed.ac.jp

Sponsor
Institute	SAPPORO MEDICAL UNIVERSITY
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Sapporo Medical University Hospital, Clinical Research Review Committee
Address	291, S1, W16, Chuo-Ku, Sapporo, Hokkaido 0608543, JAPAN
Tel	0116112111
Email	ji-rskk@sapmed.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	札幌医科大学附属病院（北海道）、JR札幌病院（北海道）・札幌道都病院（北海道）・東札幌病院（北海道）・ことに乳腺クリニック（北海道）・札幌乳腺クリニック（北海道）・東邦大学大橋病院（東京都）・昭和大学附属病院（東京都）・日本医科大学付属病院（東京都）・旭川医科大学病院（北海道）・三重大学医学部附属病院（三重県）・根室市立病院（北海道）・札幌里塚病院（北海道）

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 05 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	Enrolling by invitation
Date of protocol fixation	2020 Year 02 Month 13 Day
Date of IRB	2020 Year 03 Month 12 Day
Anticipated trial start date	2020 Year 03 Month 12 Day
Last follow-up date	2030 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NONE

Management information
Registered date	2020 Year 12 Month 03 Day
Last modified on	2021 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048653