UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cross-sectional investigation of Hand-Foot Syndrome and risk events in cancer patients undergoing chemotherapy
Title of the study (Brief title)	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	Hiroko Komatsu
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582
TEL	03-5363-3733
Email	komah@sfc.keio.ac.jp

Public contact
Name of contact person	Kaori Yagasaki
Organization	Keio University
Division name	Faculty of Nursing and Medical Care
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028262