UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041348
Receipt number 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 16:05:33

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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 or person

Institute

Saitama Prefectural University

Institute

Department

Personal name



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

Value
https://center6.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