UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of an educational program for medical staff giving grief care to children of cancer patients
Title of the study (Brief title)	Development of an educational program for medical staff giving grief care to children of cancer patients
Region	Japan

Condition
Condition	Medical staff
Classification by specialty	Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop an educational program for medical staff giving grief care to children of cancer patients and assess its effectiveness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	conceptions of essential practical knowledge and activities regarding grief care for children, before the seminar and 3 months after the seminar, essential practical knowledge regarding grief care for children, right after the seminar.
Key secondary outcomes	A recording of group work during the session on grief care planning and practical approach, and the results of participants.

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	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Essential practical knowledge and practice opportunity for grief care for children The duration of the seminar is 7 hours,held for a different group of participants.
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	Medical staff who have participated in the basic educational seminar for medical staff giving grief care to children of cancer patients, or medical staff who are currently having difficulty giving such care and are in need of educational support.
Key exclusion criteria	Medical staff who did not agree to be included in the study,participants of the first seminar are excluded from the second seminar.
Target sample size	60

Research contact person
Name of lead principal investigator	Hideko Kojima
Organization	Kitasato University
Division name	School of Nursing
Address	2-1-1,Kitasato,Minamiku,Sagamihara,KANAGAWA,252-0329,Japan.
TEL	042-778-9380
Email	hideko-k@nrs.kitasato-u.ac.jp

Public contact
Name of contact person	Hideko Kojima
Organization	Kitasato University
Division name	School of Nursing
Address	2-1-1,Kitasato,Minamiku,Sagamihara,KANAGAWA,252-0329,Japan.
TEL	042-778-9281
Homepage URL
Email	hideko-k@nrs.kitasato-u.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 12 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 15 Day
Last follow-up date	2018 Year 10 Month 30 Day
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	2015 Year 12 Month 11 Day
Last modified on	2018 Year 06 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023300