UMIN-CTR Clinical Trial

Basic information
Public title	Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients
Acronym	Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients
Scientific Title	Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients
Scientific Title:Acronym	Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients
Region	Japan

Condition
Condition	Gastric Cancer
Classification by specialty	Gastrointestinal surgery Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to assess a relationship among health literacy, quality of life and physical activity in postoperative gastric cancer patients
Basic objectives2	Others
Basic objectives -Others	Exploring the ways to improve health literacy, quality of life and physical activity in postoperative gastric cancer patients
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The degree of health literacy
Key secondary outcomes	1)The relationship between health literacy and quality of life 2)The relationship between health literacy and physical activity 3)The relationship between quality of life and physical activity

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)Patient aged over 20 2)Patient knowing the diagnosis of the disease 3)Patient underwent an operation for the purpose of radical cure between 3 and 24 months prior to taking part in the study 4)Both abdominal operation and laparoscopic operation are included and the rebuilding method are not object 5)Any or no adjuvant chemotherapy 6)agreement to participation
Key exclusion criteria	1)Patient with recurrence or any distant metastases 2)Patient who underwent an Endoscopic Mucosal Resection (EMR) or Endoscopic Submucosal Dissection (ESD) 3)Patients who underwent operation in the purpose of relieving symptoms 4)ECOG performance status of 3 or more 5)Patient who had a diagnosis of other cancers within five years 6)Patient decided by primary doctor that it's difficult to participate in the research because of cognitive impairment or mental disorders 7)Patient who is not able to complete to the questionnaire in Japanese
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hiroko Komatsu
Organization	Keio University
Division name	Graduate School of Health Management
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL	03-5363-3733
Email	komah@sfc.keio.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shinobu Uto
Organization	Keio University
Division name	Graduate School of Health Management
Zip code
Address	4411 Endo, Fujisawa-shi, Kanagawa 252-0883 Japan
TEL	0466-49-6265
Homepage URL
Email	605037@z5.keio.jp

Sponsor
Institute	Keio University Graduate School of Health Management
Institute
Department

Funding Source
Organization	Keio SFC Academic Society
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	慶應義塾大学病院(東京都)　/　Keio University hospital（Tokyo）

Other administrative information
Date of disclosure of the study information	2017 Year 07 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	2017 Year 07 Month 05 Day
Date of IRB	2017 Year 07 Month 05 Day
Anticipated trial start date	2017 Year 07 Month 31 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Measures 1)Health Literacy 2)Health Related Quality of Life 3)Physical Activity 4)Depression/Anxiety

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2020 Year 07 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032480

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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