UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044502 |
|---|---|
| Receipt number | R000050444 |
| Scientific Title | Effects of application of electronic-patient reported outcome system on QOL and compliance in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial. |
| Date of disclosure of the study information | 2021/06/11 |
| Last modified on | 2023/12/14 14:46:17 |
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Basic information
Public title
Effects of application of electronic-patient reported outcome system on QOL and compliance in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial.
Acronym
Randomized controlled trial for the effects of application of electronic-patient reported outcome system in breast cancer patients receiving adjuvant hormonal therapy.
Scientific Title
Effects of application of electronic-patient reported outcome system on QOL and compliance in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial.
Scientific Title:Acronym
Randomized controlled trial for the effects of PHR / PRO in breast cancer patients receiving adjuvant hormonal therapy.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present study conducts a randomized controlled trial to examine the effects of application of electronic-patient reported outcome system on QOL and compliance in breast cancer patients who receive adjuvant hormonal therapy.
Basic objectives2
Others
Basic objectives -Others
FACT-B (Functional Assessment of Cancer Therapy-Breast)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL evaluated by FACT-B (Functional Assessment of Cancer Therapy-Breast) at before starting adjuvant hormonal therapy and 3 months after the start of adjuvant hormonal therapy.
Key secondary outcomes
Communication between patients and professionals evaluated by EORTC QLQ-COMU26 at before starting adjuvant hormonal therapy and 3 months after the start of adjuvant hormonal therapy.
Adherence
Analyses of difference between PRO-CTCAE evaluated by patients and CTCAE v5.0-JCOG evaluated by medical stuffs (1headache,2arthralgia,3insomnia,4anxiety symptoms,5hot flushes).
Disease-free survival rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions: Patients evaluate side effects by PRO and adherence, and record them to application during adjuvant hormonal therapy.
Interventions/Control_2
Control: Patients not use of the application of electronic-patient reported outcome system.
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 who gave written informed consent.
Patients who receive first line adjuvant hormonal therapy (anastrozole, retrozole, or exemestane) at Breast Center in Showa University.
Patients who consult a clinic related to Showa University hospital during adjuvant hormonal therapy.
Patients who can cooperate with the questionnaire.
Key exclusion criteria
Patients who had received hormonal therapy in the past.
Patients with recurrent breast cancer.
Patients who cannot evaluate symptoms due to mental illness or cognitive dysfunction.
Patients who cannot operate smartphones or tablets.
Patients who cannot use of email.
Target sample size
130
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
| 2021 | Year | 06 | Month | 11 | 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
130
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050444
