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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
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 | 2020/07/29 |
Basic information | ||
Public title | Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients |
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Acronym | Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients |
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Scientific Title | Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients |
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Scientific Title:Acronym | Relationship of Health Literacy, Health Related Quality of Life and Physical Activity among Postoperative Gastric Cancer Patients |
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Region |
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Condition | |||
Condition | Gastric Cancer | ||
Classification by specialty |
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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
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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 | |
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Interventions/Control_6 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Keio University | ||||||
Division name | Graduate School of Health Management | ||||||
Zip code | |||||||
Address | 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582 | ||||||
TEL | 03-5363-3733 | ||||||
komah@sfc.keio.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
605037@z5.keio.jp |
Sponsor | |
Institute | Keio University Graduate School of Health Management
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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 | |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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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 |
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Last modified on |
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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 |