UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035439 |
|---|---|
| Receipt number | R000040373 |
| Scientific Title | A survey of psychosocial difficulties and growth among Adolescents and Young Adults with cancer |
| Date of disclosure of the study information | 2019/01/04 |
| Last modified on | 2022/12/12 19:01:25 |
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Basic information
Public title
A survey of psychosocial difficulties and growth among Adolescents and Young Adults with cancer
Acronym
SPEC A 1
Scientific Title
A survey of psychosocial difficulties and growth among Adolescents and Young Adults with cancer
Scientific Title:Acronym
SPEC A 1
Region
| Japan |
Condition
Condition
Adolescents and Young Adults with cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Narrative objectives is to understand psychosocial difficulties and growth among Adolescents and Young Adults with cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome is to reveal psychosocial difficulties and post traumatic growth among Adolescents and Young Adults with cancer
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
| Other |
Interventions/Control_1
questionnaire survey
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
| 15 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed and understanding their cancer.
2. Patients aged 0-39 years at diagnosis.
3. age 15-39 years
Key exclusion criteria
1 patients judged to be ineligible by principal investigator
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Motohiro |
| Middle name | |
| Last name | Matsui |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Pediatric Hematology/Oncology
Zip code
1830869
Address
2-8-29, Musashidai, Fuchushi, Tokyo
TEL
042-300-5111
motohiro_matsui@tmhp.jp
Public contact
Name of contact person
| 1st name | Motohiro |
| Middle name | |
| Last name | Matsui |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Pediatric Hematology/Oncology
Zip code
1830869
Address
2-8-29, Musashidai, Fuchushi, Tokyo
TEL
042-300-5111
Homepage URL
http://www.byouin.metro.tokyo.jp/shouni/tiken/koukaigenkou/h29b-123doctor.pdf
motohiro_matsui@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Promotion of Cancer Research in Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Children's Medical Center
Address
2-8-29, Musashidai, Fuchushi, Tokyo
Tel
052-300-5111
sn_crsc03@tmhp.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
東京都立小児総合医療センター
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 12 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 04 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040373
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
