UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024459 |
|---|---|
| Receipt number | R000028145 |
| Scientific Title | The inpact of cancer psychological intervention on parent and child |
| Date of disclosure of the study information | 2016/10/19 |
| Last modified on | 2017/11/07 12:41:32 |
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Basic information
Public title
The inpact of cancer psychological intervention on parent and child
Acronym
The inpact of cancer psychological intervention on parent and child
Scientific Title
The inpact of cancer psychological intervention on parent and child
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masatoshi Gika |
Organization
Saitama medical center, Saitama medical university
Division name
Department of General Thoracic Surgery
Zip code
Address
1981 Kamoda Kawagoe Saitama
TEL
049-228-3400
Gika@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuri Igarashi |
Organization
Saitama medical center, Saitama medical university
Division name
Department of Psychiatry
Zip code
Address
1981 Kamoda Kawagoe Saitama
TEL
049-228-3400
Homepage URL
igayuri@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028145
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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