UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042365 |
|---|---|
| Receipt number | R000048361 |
| Scientific Title | Effects of PHR/PRO(Personal Health Record/Patient Reported Outcome) on behavioral change in patients with breast cancer. |
| Date of disclosure of the study information | 2020/11/06 |
| Last modified on | 2023/12/12 10:04:11 |
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Basic information
Public title
Effects of PHR/PRO(Personal Health Record/Patient Reported Outcome) on behavioral change in patients with breast cancer.
Acronym
Behavioral change in patients with breast cancer by using PHR/PRO.
Scientific Title
Effects of PHR/PRO(Personal Health Record/Patient Reported Outcome) on behavioral change in patients with breast cancer.
Scientific Title:Acronym
Behavioral change in patients with breast cancer by using PHR/PRO.
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate the effects of application-base physical condition recording on QOL of patients with breast cancer who receive adjuvant hormonal therapy.
Basic objectives2
Others
Basic objectives -Others
We collect opinions from the patients regarding the operability and visibility of the app.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FACT-B(Functional Assessment of Cancer Therapy-Breast);before starting adjuvant hormonal therapy and 1 month after the use of app.
Key secondary outcomes
Adverse events
Adherence
Questionnaire for the use of app
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients receiving first line adjuvant hormonal therapy at Breast Center in Showa University
Key exclusion criteria
1Patients who had received hormonal therapy in the past
2Patients with recurrent breast cancer
3Patients who cannot operate smartphones or tablets
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Nakamura |
Organization
Showa University
Division name
Department of Breast Surgical Oncology
Zip code
142-8666
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8511
breastc@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Okuyama |
Organization
Showa University
Division name
Department of Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
TEL
03-3784-8511
Homepage URL
hiromiok@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Showa University graduate School of Medicine
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan
Tel
03-3784-8129
m-rinri@ofc.showa-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.eurjbreasthealth.com/archives/archive-detail/article-preview/application-of-personal-hea
Publication of results
Published
Result
URL related to results and publications
https://www.eurjbreasthealth.com/archives/archive-detail/article-preview/application-of-personal-hea
Number of participants that the trial has enrolled
14
Results
Fourteen patients were enrolled.
All patients could use the PHR app during the study period without any negative effects on QoL.
The questionnaire revealed that approximately 70% wanted to use the PHR app in the future to communicate with medical staff and to report adverse events. Specifically, 90% of patients who experienced difficulty communicating with medical staff wanted to use the PHR app.
Results date posted
| 2022 | Year | 11 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All patients were positive for hormone receptors and received tamoxifen, anastrozole, or letrozole as adjuvant hormonal therapy.
Nine patients were administered tamoxifen, four patients letrozole, and one patient anastrozole.
Three and ten patients received neoadjuvant chemotherapy and radiotherapy, respectively, before starting adjuvant hormonal therapy.
Participant flow
The patients were asked to collect PROs related to physical conditions, symptoms, and medications on their PHR app from the beginning of therapy for one month.
We employed the cancer notebook application Welby MyKarte ONC, which can be freely used by anyone, as a PHR app.
Quality of life was evaluated before treatment initiation and one month after.
Patients completed a questionnaire of their opinions concerning the PHR app after use.
Adverse events
Typical side effects induced by hormonal therapy, such as joint pain, hot flashes, and depression, occurred which worsen the QoL of the patients
Outcome measures
FACT-B
Questionnaire of their opinions concerning the PHR app after use
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 08 | Day |
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 10 | Month | 31 | Day |
Other
Other related information
Observational study
1FACT-B questionnaire(Before starting adjuvant hormonal therapy and 1 month after the use of app)
2Survey the information entered in the app for a month.
Adverse events
Adherence
Management information
Registered date
| 2020 | Year | 11 | Month | 06 | Day |
Last modified on
| 2023 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048361
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