UMIN-CTR Clinical Trial

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