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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011471
Receipt No. 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

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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
Email

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
Email yagasaki@sfc.keio.ac.jp

Sponsor
Institute Faculty of Nursing and Medical Care, Keio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012599

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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