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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041348
Receipt No. R000047204
Scientific Title Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Date of disclosure of the study information 2020/08/10
Last modified on 2020/08/07

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Basic information
Public title Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Acronym Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Scientific Title Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Scientific Title:Acronym Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aimed to clarify the outcomes of a PRO (Patient reported outcome) system (ii-navi 1st version) that supports self-care in breast cancer patients receiving hormone therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes knowledge of hormone therapy, psychological well-being, and QOL
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 ii-navi is composed of a slide show and checksheet used to comprehend subjective symptoms and hardships in daily life while undergoing treatment. The system was loaded onto a USB and utilized once a month for 3 months on a home computer by breast cancer patients.
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 The subjects were women under age 50 who had been receiving hormone therapy from 3 months to less than 2 years. In addition, eligibility criteria prescribed that subjects be capable of using Microsoft Excel.
Key exclusion criteria Exclusion criteria excluded those experiencing relapse/metastases and psychiatric disorders.
Target sample size 144

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 343-8540
Address San-Nomiya, Koshigaya-shi, Saitama
TEL 0489710500
Email 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 343-8540
Address San-Nomiya, Koshigaya-shi, Saitama
TEL 0489710500
Homepage URL
Email iioka-yukiko@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

Funding Source
Organization This study was implemented with a Grant-in-Aid for Scientific Research from The Ministry of Education, Culture, Sports, Science and Technology.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Prefectural University
Address San-Nomiya, Koshigaya-shi, Saitama
Tel 0489710500
Email 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

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 10 Day

Related information
URL releasing protocol Unpublished
Publication of results Unpublished

Result
URL related to results and publications Unpublished
Number of participants that the trial has enrolled 106
Results Data was analyzed for the intervention group (38 subjects) and control group (51 subjects).
We compared the scores of the outcome measures (knowledge, psychological well-being, QOL) of the intervention group and the control group.

In addition, we examined the side effects of the intervention group and changes in the distress scale during the treatment period.
Results date posted
2020 Year 08 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Half of the subjects were at stage I breast cancer.
All subjects took tamoxifen orally, and about 30% received LH-RH agonist treatment.
Participant flow 106 people were enrolled in this study.
We assigned 51 patients to the intervention group and 55 to the control group.
There were 8 who did not meet the eligibility criteria and 9 who dropped out.
Eventually, there were 38 intervention groups and 51 control groups.
Adverse events nothing special
Outcome measures Knowledge of hormone therapy
Psychological well-being
QOL
Sense of contentment in daily life while undergoing treatment
Satisfaction with medical treatment
Image of hormone therapy
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 01 Month 10 Day
Date of IRB
2013 Year 11 Month 18 Day
Anticipated trial start date
2014 Year 01 Month 10 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 07 Day
Last modified on
2020 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047204

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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