UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011471 |
|---|---|
| Receipt number | R000012599 |
| Scientific Title | Nursing Practice: Improving Adherence to Oral Chemotherapy |
| Date of disclosure of the study information | 2013/08/14 |
| Last modified on | 2014/08/18 10:00:56 |
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Basic information
Public title
Nursing Practice: Improving Adherence to Oral Chemotherapy
Acronym
Nursing Practice in Oral Chemotherapy
Scientific Title
Nursing Practice: Improving Adherence to Oral Chemotherapy
Scientific Title:Acronym
Nursing Practice in Oral Chemotherapy
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify trends and challenges in nursing practice to improve adherence to oral chemotherapy.
Basic objectives2
Others
Basic objectives -Others
Nursing practice (including assessment, self-management support, monitoring)Facility characteristics, nursing process
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nursing practice (including assessment, self-management support, monitoring)
Key secondary outcomes
Facility characteristics, nursing process, patient characteristics, oral chemotherapy in outpatient settings
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
Male and Female
Key inclusion criteria
Outpatient clinics in cancer hospitals in Japan, and general hospitals with more than 300 beds and more than one following nurse: 1) more than 3-year experience, and 2) experienced leader at outpatient chemotherapy clinic.
Key exclusion criteria
Nurses who are not eligible for the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Komatsu |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582
TEL
03-5363-3733
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Yagasaki |
Organization
Keio University
Division name
Faculty of Nursing and Medical Care
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582
TEL
03-5363-2157
Homepage URL
yagasaki@sfc.keio.ac.jp
Sponsor or person
Institute
Faculty of Nursing and Medical Care, Keio University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research(A)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
がん診療連携拠点病院および一般病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.biomedcentral.com/1756-0500/7/259
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
| 2012 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 14 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nursing practice (including assessment, self-management support, monitoring), Facility characteristics, nursing process, patient characteristics, oral chemotherapy in outpatient settings
Management information
Registered date
| 2013 | Year | 08 | Month | 13 | Day |
Last modified on
| 2014 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012599
