UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043414
Receipt No. R000049568
Scientific Title Effects of foot bath and hand care on reducing fatigue in terminal cancer patients
Date of disclosure of the study information 2021/02/23
Last modified on 2021/02/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.