UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043414 |
|---|---|
| Receipt number | 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 | 2023/04/05 11:30:40 |
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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
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
mai_h@iwate-pu.ac.jp
Sponsor or person
Institute
Iwate Prefectural University
Institute
Department
Personal name
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
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
Enrolling by invitation
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
| 2025 | 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
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049568
| 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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