UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the nursing support program in the decision making of the medical treatment policy of cancer patients receiving chemotherapy
Title of the study (Brief title)	Development of the nursing support program in the decision making of the medical treatment policy of cancer patients receiving chemotherapy
Region	Japan

Condition
Condition	advanced cancer
Classification by specialty	Nursing
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Development of the nursing support program to promote the proactive decision of advanced cancer patients receiving chemotherapy in a medical treatment policy based on a wish and sense of values
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decision Conflict Scale
Key secondary outcomes	State-Trait Anxiety Inventory Brief Cancer-related Worry Self-efficacy scale for advanced cancer

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	I support it in an interview form in front and behind an informed consent It's composed of 1 program by 3 times of interview, and 1 program for 3 months is performed total of 3 times
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	A disease name, a diagnosis of recurrence and a metastasis, the treatment purpose and possibility of the therapeutic effect are explained At the time to consider effect measurement of chemotherapy and medicine change. A doctor judges that there is ability of the decision making Consent is got by this research
Key exclusion criteria	Communication is difficult in Japanese The patient of the mind and body state who can't stand interview Performance Status is more than 3
Target sample size	30

Research contact person
Name of lead principal investigator	Akiko Honda
Organization	Tokyo Medical and Dental University
Division name	graduate school of health care sciences
Address	1-5-45 Bunkyou-ku Yushima, Tokyo
TEL	03-5803-5355
Email	akikchn@tmd.ac.jp

Public contact
Name of contact person	Yuka Ishihara
Organization	Tokyo Medical and Dental University
Division name	graduate school of health care sciences
Address	1-5-45 Bunkyou-ku Yushima, Tokyo
TEL	03-3813-6111
Homepage URL
Email	yishihara.chn@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
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	2016 Year 05 Month 19 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 07 Month 26 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 05 Month 19 Day
Last modified on	2016 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025761