UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026991 |
|---|---|
| Receipt number | R000030948 |
| Scientific Title | Development of a new management model for oral outpatient chemotherapy featured by concerted interventions by physicians and pharmacists |
| Date of disclosure of the study information | 2017/04/14 |
| Last modified on | 2017/04/14 07:21:17 |
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Basic information
Public title
Development of a new management model for oral outpatient chemotherapy featured by concerted interventions by physicians and pharmacists
Acronym
Development of a new pharmacists' management model for oral outpatient chemotherapy
Scientific Title
Development of a new management model for oral outpatient chemotherapy featured by concerted interventions by physicians and pharmacists
Scientific Title:Acronym
Development of a new pharmacists' management model for oral outpatient chemotherapy
Region
| Japan |
Condition
Condition
Colorectal cancer
Pancreatic cancer
Biliary cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development new pharmaceutical model for oral outpatient chemotherapy, which is featured by concerted interventions by physicians and pharmacists
Basic objectives2
Others
Basic objectives -Others
Feasibility of a new pharmaceutical model
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the feasibility of new model
Key secondary outcomes
To examine if the model makes any effects on adherence, ADEs, and patient's satisfaction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Clinical pharmacist's; Lecture for treatment, Counseling, Information for Community pharmacist, Develop a care plan
Community pharmacist; Telephone follow up
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients treated with S-1 as a single agent or in combination with other agents, and had to give written consent to participate.
Key exclusion criteria
Doctor considers unsuitable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Ando Makihara |
Organization
National Cancer Center Hospital
Division name
Pharmacy
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
reando@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Ando Makihara |
Organization
National Cancer Center Hospital
Division name
Pharmacy
Zip code
Address
Tsukiji 5-1-1, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
reando@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 14 | 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 | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 14 | Day |
Last modified on
| 2017 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030948
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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