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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028373
Receipt No. R000032480
Scientific Title Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients
Date of disclosure of the study information 2017/07/30
Last modified on 2018/08/17

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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 No longer recruiting
Date of protocol fixation
2017 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 Day
Last follow-up date
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
2018 Year 08 Month 17 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
Registered date File name

Research case data
Registered date File name


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