UMIN-CTR Clinical Trial

Basic information
Public title	Effects of foot bath and hand care on reducing fatigue in terminal cancer patients
Acronym	Effects of foot bath and hand care on reducing fatigue in terminal cancer patients
Scientific Title	Effects of foot bath and hand care on reducing fatigue in terminal cancer patients
Scientific Title:Acronym	Effects of foot bath and hand care on reducing fatigue in terminal cancer patients
Region	Japan

Condition
Condition	terminal cancer
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the effects of foot bath and hand care on fatigue in terminal cancer patients by conducting a crossover randomized controlled trial (RCT) with the degree of fatigue as the primary endpoint.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in fatigue according to the Japanese version of the Brief Fatigue Inventory (BFI)
Key secondary outcomes	Changes in fatigue according to the Japanese version of the Brief Fatigue Inventory (BFI) Change in multidimensional fatigue by the Hirai Cancer Fatigue Scale (HCFS) Symptom assessment by the Edmonton Symptom Assessment System revised (ESAS-r-J) Change in Autonomic nervous system

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Foot Bath 10 minutes wrapped warm foot-bath
Interventions/Control_2	Hand care 15 minutes Hand care
Interventions/Control_3	control Normal conversation
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) 20 years of age or older (2) Patients whose condition is considered stable during the intervention period (approximately 1 week) according to the judgment of the attending physician. (3) PS, gender, and cancer type are not required. (4) Patients admitted to a palliative care unit in the Tohoku
Key exclusion criteria	(1) Patients who are unable to give their own consent for research cooperation (2) Patients who are unable to answer the questionnaire (including oral answers) due to cognitive decline, etc. (3) Patients whose condition is expected to deteriorate rapidly by foot bathing or hand care. 3) Patients whose condition is expected to deteriorate rapidly during foot bathing or hand care. (4) Other cases in which the person in charge of the survey judges that participation in the survey is inappropriate.
Target sample size	105

Research contact person
Name of lead principal investigator	1st name Mai Middle name Last name Hosokawa
Organization	Iwate Prefectural University
Division name	Faculty of Nursing
Zip code	0200693
Address	152-52, Sugo, Takizawa, Iwate, JAPAN
TEL	0196942200
Email	mai_h@iwate-pu.ac.jp

Public contact
Name of contact person	1st name Mai Middle name Last name Hosokawa
Organization	Iwate Prefectural University
Division name	Faculty of Nursing
Zip code	0200693
Address	152-52, Sugo, Takizawa, Iwate, JAPAN
TEL	0196942200
Homepage URL
Email	mai_h@iwate-pu.ac.jp

Sponsor
Institute	Iwate Prefectural University
Institute
Department

Funding Source
Organization	Iwate Prefectural University
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Iwate Prefectural University Research Ethics Committee
Address	152-52, Sugo, Takizawa, Iwate, JAPAN
Tel	0196943330
Email	k-sien@ml.iwate-pu.ac.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 23 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	Preinitiation
Date of protocol fixation	2020 Year 09 Month 01 Day
Date of IRB	2020 Year 09 Month 23 Day
Anticipated trial start date	2021 Year 02 Month 22 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 02 Month 22 Day
Last modified on	2021 Year 02 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049568

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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