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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033347
Receipt No. 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 2018/07/10

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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
Middle name
Last name YUKIKO IIOKA
Organization Saitama Prefectural University
Division name Graduate course of Health and Social Services
Zip code
Address 820 San-nomiya, Koshigaya-shi,Saitama343-8540, JAPAN
TEL 048-973-4168
Email iioka-yukiko@spu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name YUKIKO IIOKA
Organization Saitama Prefectural University
Division name Graduate course of Health and Social Services
Zip code
Address 820 San-nomiya, Koshigaya-shi, Saitama, 343-8540, JAPAN
TEL 048-973-4168
Homepage URL
Email iioka-yukiko@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

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
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 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
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038008

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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