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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042913
Receipt No. R000047531
Scientific Title An outcome reserch of new support tools among childhood cancer survivors and adolescents and young Adults with cancer
Date of disclosure of the study information 2021/01/05
Last modified on 2021/01/05

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Basic information
Public title An outcome reserch of new support tools among childhood cancer survivors and adolescents and young Adults with cancer
Acronym An outcome reserch of new support tools among childhood cancer survivors and adolescents and young Adults with cancer
Scientific Title An outcome reserch of new support tools among childhood cancer survivors and adolescents and young Adults with cancer
Scientific Title:Acronym An outcome reserch of new support tools among childhood cancer survivors and adolescents and young Adults with cancer
Region
Japan

Condition
Condition childhood cancer survivor and Adolescents and Young Adults with cancer
Classification by specialty
Hematology and clinical oncology Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Narrative objectives is to understand the efficacy of new support tools among childhood cancer survivor and 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 the positive effects of new support tools for psychosocial growth among childhood cancer survivor and adolescents and young adults with cancer
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 who opt out
2 patients judged to be ineligible by principal investigator
Target sample size 150

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 1838569
Address 2-8-29, Musashidai, Fuchushi, Tokyo
TEL 0423005111
Email 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 1838569
Address 2-8-29, Musashidai, Fuchushi, Tokyo
TEL 0423005111
Homepage URL
Email motohiro_matsui@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization the mitsubishi foundation
heartlink working project
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 042-300-5111
Email 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

Other administrative information
Date of disclosure of the study information
2021 Year 01 Month 05 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 Open public recruiting
Date of protocol fixation
2020 Year 10 Month 12 Day
Date of IRB
2020 Year 10 Month 12 Day
Anticipated trial start date
2021 Year 01 Month 05 Day
Last follow-up date
2025 Year 10 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective, questionnaire-based study was conducted among AYA cancer patients and survivors aged 0-39 years at diagnosis. We investigate a self-report measure of PTG (PTGIX J). Diagnosis, treatment, peer support (affiliation to AYA patients' community and friendship with other AYA cancer patients), and social status information, SNS use were collected from questionnaires. Multiple regression analysis was used to identify significant correlates of PTG.

Management information
Registered date
2021 Year 01 Month 05 Day
Last modified on
2021 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047531

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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