UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043504 |
|---|---|
| Receipt number | R000049677 |
| Scientific Title | Effect of a group intervention for children and their parents who have cancer. |
| Date of disclosure of the study information | 2021/03/04 |
| Last modified on | 2023/03/06 09:32:18 |
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Basic information
Public title
Effect of a group intervention for children and their parents who have cancer.
Acronym
Effect of a group intervention for children and their parents who have cancer.
Scientific Title
Effect of a group intervention for children and their parents who have cancer.
Scientific Title:Acronym
Effect of a group intervention for children and their parents who have cancer.
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aim is the effects of participation in the CLIMB program on parents who have cancer treatment and their children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Children
Quality of Life
SRS-C: Stress Response Scale for Children
Scale of Self- Affirmation
Evaluation time is before and after intervention
Parents
FACIT-sp: Functional Assessment of Cancer Therapy- Spiritual
STAI: State- Trait Anxiety Inventory
Challenge and Hope
Evaluation time is before and after intervention
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
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
CLIMB's Facilitators will implement a program for children who have parental cancer to improve their ability to cope with the stress associated with their parents' illness.
Parents who have cancer talk freely with a medical professional to reduce the stress of the parents.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants who meet criteria below
; have a received diagnosis and notice of cancer, and their children
; a patient's presumed life expectancy is six months or more
; can read and write Japanese
; are an intention which participants in the complete of a CLIMB program
; can give informed consent
Key exclusion criteria
Participants who meet exclusion criteria below
; have remarkable cognitive dysfunction
; are having the psychiatric disorder diagnosed
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Akagawa |
Organization
Akita University
Division name
Depeartment of Nursing
Zip code
010-8543
Address
1-1-1 Hondo, Akita city, Akita prefecture
TEL
018-884-6551
abe0204@hs.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Akagawa |
Organization
Akita University
Division name
Depeartment of Nursing
Zip code
010-8543
Address
1-1-1 Hondo, Akita city, Akita prefecture
TEL
018-884-6551
Homepage URL
abe0204@hs.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
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
Akita University
Address
1-1-1 Hondo, Akita city, Akita prefecture
Tel
018-884-6461
soken@hos.akita-u.ac.jp
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
| 2021 | Year | 03 | Month | 04 | 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
| 2021 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 06 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 06 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 06 | Day |
Other
Other related information
Intervention cannot be performed due to COVID-19.
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049677
| 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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| Registered date | File name |
