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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024569
Receipt No. 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

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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
Email 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
Email yagasaki@sfc.keio.ac.jp

Sponsor
Institute Faculty of Nursing and Medical Care, Keio University
Institute
Department

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
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)

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028262

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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