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 |
Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Effectiveness of a PRO (ii-navi 1st ver.) for Breast Cancer Patients Receiving Hormone Therapy :A Randomized Controlled Trial
Japan |
Breast Cancer
Breast surgery | Nursing |
Malignancy
NO
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.
Efficacy
knowledge of hormone therapy, psychological well-being, and QOL
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Educational,Counseling,Training
Behavior,custom |
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.
Usual care
20 | years-old | < |
50 | years-old | > |
Female
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.
Exclusion criteria excluded those experiencing relapse/metastases and psychiatric disorders.
144
1st name | Yukiko |
Middle name | |
Last name | Iioka |
Saitama Prefectural University
Graduate Course of Health and Social Services
343-8540
San-Nomiya, Koshigaya-shi, Saitama
0489710500
iioka-yukiko@spu.ac.jp
1st name | Yukiko |
Middle name | |
Last name | Iioka |
Saitama Prefectural University
Graduate Course of Health and Social Services
343-8540
San-Nomiya, Koshigaya-shi, Saitama
0489710500
iioka-yukiko@spu.ac.jp
Saitama Prefectural University
This study was implemented with a Grant-in-Aid for Scientific Research from The Ministry of Education, Culture, Sports, Science and Technology.
Japanese Governmental office
Saitama Prefectural University
San-Nomiya, Koshigaya-shi, Saitama
0489710500
iioka-yukiko@spu.ac.jp
NO
聖路加国際病院
2020 | Year | 08 | Month | 10 | Day |
Unpublished
Unpublished
Unpublished
106
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.
2020 | Year | 08 | Month | 07 | Day |
Half of the subjects were at stage I breast cancer.
All subjects took tamoxifen orally, and about 30% received LH-RH agonist treatment.
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.
nothing special
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
Completed
2014 | Year | 01 | Month | 10 | Day |
2013 | Year | 11 | Month | 18 | Day |
2014 | Year | 01 | Month | 10 | Day |
2014 | Year | 12 | Month | 31 | Day |
2020 | Year | 08 | Month | 07 | Day |
2020 | Year | 08 | Month | 07 | Day |
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 |