UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016828
Receipt No. R000019526
Scientific Title Support for children informed of theirs parents cancer-Effect of the CLIMB program
Date of disclosure of the study information 2015/03/17
Last modified on 2019/05/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Support for children informed of theirs parents cancer-Effect of the CLIMB program
Acronym Support for children informed of theirs parents cancer-Effect of the CLIMB program
Scientific Title Support for children informed of theirs parents cancer-Effect of the CLIMB program
Scientific Title:Acronym Support for children informed of theirs parents cancer-Effect of the CLIMB program
Region
Japan

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

Objectives
Narrative objectives1 To assess the effects of the CLIMB program support to a cancer patient and their child
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the Kid-KINDLR(Questiomairefor
Measurillg Health-Related Quality of
Life in Children)
Key secondary outcomes the Japanese version of the CLIMB Program Scores

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
Behavior,custom
Interventions/Control_1 CLIMB program
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
12 years-old >
Gender Male and Female
Key inclusion criteria 1) a schoolchild
2) the child telling that a parent has cancer
3) a child agrees to participation in a program
4) parents(a cancer patient is included) agrees to participation in a program
5) the child who can express his feeling by a language
6) the child who can carry on activity for 2 hours by a group
Key exclusion criteria 1)the child who is more than 12 years old less than 6 years old
2) the child who isn't explaining that a parent has cancer
3) the child who can't participate in a session for 2 hours in the group
4) the child who can't express his feeling by a language
5) when a child isn't hoping for participation even if a parent is hoping for participation.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sakiko Kondo
Organization Keio University Hospital
Division name Nursing Department
Zip code
Address 35 Shinanomachi,Shinjukuku,Tokyo 1608582,Japan
TEL 03-3353-1211
Email sakiko.kondo@adst.keio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sakiko Kondo
Organization Keio University Hospital
Division name Nursing Department
Zip code
Address 35 Shinanomachi,Shinjukuku,Tokyo 1608582,Japan
TEL 03-3353-1211
Homepage URL
Email sakiko.kondo@adst.keio.ac.jp

Sponsor
Institute Keio University Hospital
Institute
Department

Funding Source
Organization Keio University Clinical Tumor Sience Donation Lecture
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 Month 17 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 Completed
Date of protocol fixation
2014 Year 03 Month 24 Day
Date of IRB
2014 Year 03 Month 24 Day
Anticipated trial start date
2014 Year 06 Month 02 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 17 Day
Last modified on
2019 Year 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.