UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024569 |
|---|---|
| Receipt number | R000028262 |
| Scientific Title | A cross-sectional investigation of Hand-Foot Syndrome and risk events in cancer patients undergoing chemotherapy |
| Date of disclosure of the study information | 2016/11/07 |
| Last modified on | 2018/04/28 12:11:38 |
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Basic information
Public title
A cross-sectional investigation of Hand-Foot Syndrome and risk events in cancer patients undergoing chemotherapy
Acronym
A cross-sectional investigation of Hand-Foot Syndrome and risk events in cancer patients undergoing chemotherapy
Scientific Title
A cross-sectional investigation of Hand-Foot Syndrome and risk events in cancer patients undergoing chemotherapy
Scientific Title:Acronym
A cross-sectional investigation of Hand-Foot Syndrome and risk events in cancer patients undergoing chemotherapy
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study purpose: Focusing on the hand-foot syndrome associated with chemotherapy, to investigate a situation of risk events (falls, external injury, burn injury, etc.) and an association with physical activities and the QOL (Quality of Life).
Basic objectives2
Others
Basic objectives -Others
Risk events (falls, external injury, burn injury, etc.)
Physical activities
QOL
Psychology
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
risk events (falls, external injury, burn injury, etc.)
Key secondary outcomes
QOL(EQ-5D,DLQI)
Physical activities(IPAQ)
Psychology(K6)
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 20 or more (no upper age limit)
2)Patient who is able to complete to the questionnaire in Japanese.
3)Patient with the chemotherapy induced hand-foot syndrome (CTCAE Grade 1 or more)
4)Stage and metastasis are no object.
Key exclusion criteria
1)ECOG performance status 3 or more
2)Patient decided by primary doctor that it's difficult to participate in the research because of cognitive impairment or mental disorders
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
Faculty of Nursing and Medical Care
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
| 1st name | |
| Middle name | |
| Last name | Kaori Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL
03-5363-2157
Homepage URL
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Faculty of Nursing and Medical Care, Keio University
Institute
Department
Personal name
Funding Source
Organization
JSPS KAENHI Grant Number 16H02696
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Risk events (falls, external injury, burn injury, etc.)
Physical activities
QOL
Psychology
Management information
Registered date
| 2016 | Year | 10 | Month | 26 | Day |
Last modified on
| 2018 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028262
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
