UMIN-CTR Clinical Trial

Basic information
Public title	Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Acronym	Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Scientific Title	Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Scientific Title:Acronym	Research of health-related QOL with EQ-5D-5L using a web application by community pharmacists
Region	Japan

Condition
Condition	All diseases; patients who have been issued prescriptions for treatment
Classification by specialty	Medicine in general Surgery in general Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Clarify the change of health-related QOL during treatment
Basic objectives2	Others
Basic objectives -Others	Clarify adverse events affecting health-related QOL
Trial characteristics_1	Others
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	An observation period of 6 months or more will be provided from the start of registration. Health-related QOL is measured 4 or more times during the observation period. The primary endpoint is quality-adjusted life years (QALY).
Key secondary outcomes	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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients who are 20 years old or more at the time of consent acquisition. (2) Patients provided written informed consent (3)Patients who have been issued prescriptions by medical institutions
Key exclusion criteria	(1)Requested for cancellation from patients (2)Interrupted due to the circumstances of the research patients (moving, changing doctor / hospital, busy, unfollowable) (3)Judged that evaluation is not possible due to serious deviation from protocol (4)Patients judged inappropriate in this study
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Hisanori Middle name Last name Shimizu
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name	Department of Pharmacy
Zip code	135-8550
Address	3-8-31, Ariake, Koto-ku, Tokyo, Japan
TEL	03-3570-0214
Email	hisanori.shimizu@jfcr.or.jp

Public contact
Name of contact person	1st name Hayato Middle name Last name Murata
Organization	Qol Co., Ltd.
Division name	Kanto Pharmacy Headquarter 1
Zip code	224-0032
Address	36-6, Chigasakichuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan
TEL	045-949-5800
Homepage URL
Email	hayato-m@pharm.showa-u.ac.jp

Sponsor
Institute	School of Nursing and Rehabilitation Sciences, Showa University
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare Health Labour Sciences Research Grant Geriatric Oncology Guideline-establishing (GOGGLE) Study Group; Geriatric Oncology Guideline-establishing (GOGGLE) Study
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	(1)QOL Co., Ltd. (2)Nihon Chouzai Co., Ltd. (3)KRAFT Inc. (4)SOGO MEDICAL CO., LTD (5)AIN PHARMACIEZ INC. (6)Study group for Comprehensive Cost-Effectiveness Analysis of Pharmacotherapy
Name of secondary funder(s)

IRB Contact (For public release)
Organization	School of Nursing and Rehabilitation Sciences, Showa University
Address	1865, Tokaichibacho, Midori-ku, Yokohama, Kanagawa, Japan
Tel	045-985-6503
Email	nr-rinri@ofc.showa-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	(1)クオール株式会社 (2)日本調剤株式会社 (3)クラフト株式会社 (4)総合メディカル株式会社 (5)株式会社アインファーマシーズ

Other administrative information
Date of disclosure of the study information	2020 Year 09 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
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 07 Month 15 Day
Date of IRB	2020 Year 07 Month 15 Day
Anticipated trial start date	2020 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 09 Month 30 Day

Other
Other related information	We research health-related QOL with EQ-5D-5L using a web application; prospective observational study.

Management information
Registered date	2020 Year 09 Month 29 Day
Last modified on	2022 Year 03 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047830