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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025671
Receipt No. R000029481
Scientific Title Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes
Date of disclosure of the study information 2017/01/17
Last modified on 2017/08/25

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Basic information
Public title Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes
Acronym Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes
Scientific Title Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes
Scientific Title:Acronym Nursing interventions for family caregiver of primary brain tumor patient, encouraging how to cope with life changes
Region
Japan

Condition
Condition family caregiver of primary malignant brain tumor patient
Classification by specialty
Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate Nursing intervention ,from the point of coping,QOL,burden
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Caregiver:
1)Coping
2)QOL
3)Burden
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
Other
Interventions/Control_1 1)Nursing assessment at least once a month
2)Nursing care based on the nursing assessment
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) Main family caregiver of primary brain tumor.
2) Patient who has the recurrence and neurological symptoms and/or brain dysfunctions. Or patient who has high possibility of recurrence and will have neurological symptoms and/or brain dysfunctions.
3) Patient and family caregiver who know patient's cancer diagnosis.
4) Patient and family caregiver who can communicate in Japanese.
Key exclusion criteria 1)family caregiver who has mental problems
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitomi Sato
Organization Chiba university
Division name Graduate school of Nursing
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8672 JAPAN
TEL 043-222-7171
Email hsato@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Sato
Organization Chiba university
Division name Graduate school of Nursing
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8672 JAPAN
TEL 043-222-7171
Homepage URL
Email hsato@chiba-u.jp

Sponsor
Institute Chiba university
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2017 Year 01 Month 17 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 Completed
Date of protocol fixation
2016 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 06 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
2017 Year 01 Month 14 Day
Last modified on
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029481

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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