UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033347 |
|---|---|
| Receipt number | R000038008 |
| Scientific Title | Effectiveness of patient report outcome system (ii-nave) for breast cancer patients during hormone therapy |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2020/07/20 10:51:30 |
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Basic information
Public title
Effectiveness of patient report outcome system (ii-nave) for breast cancer patients during hormone therapy
Acronym
ii-navi resarch
Scientific Title
Effectiveness of patient report outcome system (ii-nave) for breast cancer patients during hormone therapy
Scientific Title:Acronym
ii-navi resarch
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery | Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The porpose of this study is to clarify the effect of the patient repored outcome system(ii-navi) in brest cancer patients during hormone therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
check sheet of breast cancer patient receiveing hormone therapy
Key secondary outcomes
QOL:FACT-B
Anxiety, Depression:HADS
satisfaction of medical service:VAS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Use ii-navi
Interventions/Control_2
usual care
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
taking tamoxifen treatment
Key exclusion criteria
recurrence/metastasis
mental illness
severe anxiety/depression
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | YUKIKO |
| Middle name | |
| Last name | IIOKA |
Organization
Saitama Prefectural University
Division name
Graduate course of Health and Social Services
Zip code
3438540
Address
820 San-nomiya, Koshigaya-shi,Saitama343-8540, JAPAN
TEL
048-973-4168
iioka-yukiko@spu.ac.jp
Public contact
Name of contact person
| 1st name | YUKIKO |
| Middle name | |
| Last name | IIOKA |
Organization
Saitama Prefectural University
Division name
Graduate course of Health and Social Services
Zip code
3438540
Address
820 San-nomiya, Koshigaya-shi, Saitama, 343-8540, JAPAN
TEL
048-973-4168
Homepage URL
iioka-yukiko@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Kimura Foundation for Nursing Education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
St Luke's International Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Prefectural University
Address
820 San-nomiya, Koshigaya-shi, Saitama, 343-8540, JAPAN
Tel
048-971-0500
iioka-yukiko@spu.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
聖路加国際病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038008
| 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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| Registered date | File name |
