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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018411
Receipt No. R000021235
Scientific Title Pilot study of the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Date of disclosure of the study information 2015/12/01
Last modified on 2016/01/25

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Basic information
Public title Pilot study of the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Acronym the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Scientific Title Pilot study of the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Scientific Title:Acronym the hand treatment which reduces a palliative care unit inpatient's feeling of worthlessness
Region
Japan

Condition
Condition Cancer patient
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We verify the effect of the hand treatment which reduces the feeling of worthlessness of the patient who is in a palliative care unit.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cancer Fatigue Scale
evaluation time: Just before intervention and immediately after intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Hand treatment
Enforcement period: Three to six after patch test enforcement days
Enforcement time: 10 minutes
Number of times: 3 times
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 cancer patient in the hospital
Key exclusion criteria a patient with generation of heat beyond patient
aggravation of somatic symptoms is predicted to be with a patient
hand treatment with consciousness disorder, dementia, and symptomatic brain transition
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name yoko iwawaki
Organization Kyoto Prefectural university of Medicine
Division name School of Medicine, Department of Nursing
Zip code
Address 410, Nakagoryo-cho, Kamigyo-ku, Kyoto-shi, Kyoto
TEL 075-212-5446
Email iwawaki@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name yoko iwawaki
Organization Kyoto Prefectural university of Medicine
Division name School of Medicine, Department of Nursing
Zip code
Address School of Medicine, Department of Nursing
TEL 075-212-5446
Homepage URL
Email iwawaki@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine School of Nursing
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 01 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
2015 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 07 Month 24 Day
Last modified on
2016 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021235

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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