UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027171 |
|---|---|
| Receipt number | R000031133 |
| Scientific Title | Survey of costs and QOL related to side effects for patients undergoing outpatient chemotherapy |
| Date of disclosure of the study information | 2017/04/27 |
| Last modified on | 2017/04/27 20:58:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Survey of costs and QOL related to side effects for patients undergoing outpatient chemotherapy
Acronym
Survey of costs and QOL related to side effects
Scientific Title
Survey of costs and QOL related to side effects for patients undergoing outpatient chemotherapy
Scientific Title:Acronym
Survey of costs and QOL related to side effects
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Survey of side effects that cause factors in QOL
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL score
Before chemotherapy, before 2nd and 3rd course.
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Breast cancer patients who received their first course of intravenous chemotherapy at Gifu Municipal Hospital.
Key exclusion criteria
The patients received hormone therapy, only oral anti-cancer drug treatment or radiation therapy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhide Tanaka |
Organization
Gifu Municipal Hospital
Division name
Department of Pharmacy
Zip code
Address
7-1 kashima-cho, Gifu-shi, Gifu, Japan
TEL
+81-58-251-1101
k-tanaka@gmhosp.gifu.gifu.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhide Tanaka |
Organization
Gifu Municipal Hospital
Division name
Department of Pharmacy
Zip code
Address
7-1 kashima-cho, Gifu-shi, Gifu, Japan
TEL
+81-58-251-1101
Homepage URL
k-tanaka@gmhosp.gifu.gifu.jp
Sponsor or person
Institute
Gifu Municipal Hospital
Department of Pharmacy
Institute
Department
Personal name
Funding Source
Organization
Gifu Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 27 | 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
Completed
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 30 | Day |
Other
Other related information
In patients with side effects of malaise and nausea, it was revealed that QOL is higher when there is involvement by a pharmacist compared to without.
Management information
Registered date
| 2017 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031133
