UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039904 |
|---|---|
| Receipt number | R000041968 |
| Scientific Title | The efficacy of software to help patients understand drug costs for treatment for breast cancer |
| Date of disclosure of the study information | 2020/03/23 |
| Last modified on | 2023/03/26 09:53:28 |
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Basic information
Public title
The efficacy of software to help patients understand drug costs for treatment for breast cancer
Acronym
The efficacy of software to help patients understand drug costs for treatment for breast cancer
Scientific Title
The efficacy of software to help patients understand drug costs for treatment for breast cancer
Scientific Title:Acronym
The efficacy of software to help patients understand drug costs for treatment for breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We conducted this study to explore the software's effectiveness in understanding patients' drug costs for female breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the two groups' questionnaire scores on
1. patients' perceived level of understanding of the drug cost
2. patients' perception that drug cost is important
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using software of calculating drug costs
Interventions/Control_2
Disuding software of calculating drug costs
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
Male and Female
Key inclusion criteria
1. Patients with metastatic or advanced breast cancer
2. Patients who have started or plan to change drug therapy for metastatic or advanced breast cancer
3. Patients who have two or more treatments presented by the attending physician
4. Patients who have been given sufficient explanations to participate in this study and have given their full understanding and informed consent
Key exclusion criteria
1. Patients with dementia
2. Patients who do not have to pay for the drug
3. Patients who are judged inappropriate by the Investigator
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuba |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Surgery
Zip code
8528052
Address
Sakamoto-machi, Nagasaki
TEL
0958197316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Kuba |
Organization
Nagasaki University Graduate School of Biomedical Science
Division name
Surgery
Zip code
8528052
Address
Sakamoto-machi, Nagasaki
TEL
0958497316
Homepage URL
skuba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Graduate School of Biomedical Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Hospital review board
Address
Sakamoto-machi, Nagasaki
Tel
0958197726
gaibushikin@ml.nagasaki-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 | 03 | Month | 23 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2020 | Year | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041968
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
