UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of medication adherence with antiemetic drug therapy in breast cancer patients receiving chemotherapy.
Title of the study (Brief title)	Study of medication adherence with antiemetic drug therapy in breast cancer patients receiving chemotherapy.
Region	Japan

Condition
Condition	Breast cancer
Classification by specialty	Breast surgery Nursing Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify degree of taking medication adherence with antiemetic drug therapy in breast cancer's women receiving chemotherapy.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The degree of taking medication adherence with antiemetic drug therapy
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	1)agreement to participation 2)Understanding Japanese 3)Judged by Doctor
Key exclusion criteria	1)more than PS2 2)receiving radiotherapy at present
Target sample size	100

Research contact person
Name of lead principal investigator	Rie Shoda
Organization	Keio University Graduate School of Health Management
Division name	Nursing
Address	Shinanomachi 35,Shinjuku,Tokyo
TEL	03-5363-3733
Email	r.shoda@a3.keio.jp

Public contact
Name of contact person	Rie Shoda
Organization	Keio University Graduate School of Health Management
Division name	Nursing
Address	Shinanomachi 35,Shinjuku,Tokyo
TEL	03-5363-3733
Homepage URL
Email	r.shoda@a3.keio.jp

Sponsor
Institute	Keio University Graduate School of Health Management
Institute
Department

Funding Source
Organization	Rie Shoda
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 21 Day
Anticipated trial start date	2015 Year 06 Month 15 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	prospective study

Management information
Registered date	2015 Year 05 Month 31 Day
Last modified on	2017 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020563