UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028373
Receipt number 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 2020/07/29 00:47:02

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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 or person

Institute

Keio University Graduate School of Health Management

Institute

Department

Personal name



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

Value
https://center6.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