UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025671 |
|---|---|
| Receipt number | 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 16:58:42 |
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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
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
hsato@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029481
