UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016828 |
|---|---|
| Receipt number | 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 09:44:15 |
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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
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
sakiko.kondo@adst.keio.ac.jp
Sponsor or person
Institute
Keio University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019526
