UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The inpact of cancer psychological intervention on parent and child
Title of the study (Brief title)	The inpact of cancer psychological intervention on parent and child
Region	Japan

Condition
Condition	cancer
Classification by specialty	Medicine in general Surgery in general Adult Child
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this study, We practice the cancer education for a parent and children and am intended to examine the intervention effect.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in the relation with the child Change of the problem of the child
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Psychological intervention for cancer
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	6 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	Being a cancer patient, a family under treatment, the child Having already told that parent is a cancer to a child A child being younger than 18 years old 6 years old or older Being the person who participates in "the cancer lesson of a parent and the child", and agreed to this investigation
Key exclusion criteria	nothing
Target sample size	20

Research contact person
Name of lead principal investigator	Masatoshi Gika
Organization	Saitama medical center, Saitama medical university
Division name	Department of General Thoracic Surgery
Address	1981 Kamoda Kawagoe Saitama
TEL	049-228-3400
Email	Gika@saitama-med.ac.jp

Public contact
Name of contact person	Yuri Igarashi
Organization	Saitama medical center, Saitama medical university
Division name	Department of Psychiatry
Address	1981 Kamoda Kawagoe Saitama
TEL	049-228-3400
Homepage URL
Email	igayuri@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university
Institute
Department

Funding Source
Organization	Meiji Yasuda Mental Health Foundation
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 10 Month 19 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 19 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 10 Month 18 Day
Last modified on	2017 Year 11 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028145