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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042857
Receipt No. R000048921
Scientific Title Multicenter retrospective observational study on feasibility and preliminary effectiveness of psychological support program for AYA generation cancer patients
Date of disclosure of the study information 2020/12/25
Last modified on 2020/12/25

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Basic information
Public title Multicenter retrospective observational study on feasibility and preliminary effectiveness of psychological support program for AYA generation cancer patients
Acronym Multicenter retrospective observational study of psychological support program for AYA generation cancer patients
Scientific Title Multicenter retrospective observational study on feasibility and preliminary effectiveness of psychological support program for AYA generation cancer patients
Scientific Title:Acronym Multicenter retrospective observational study of psychological support program for AYA generation cancer patients
Region
Japan

Condition
Condition AYA generation cancer patients
Classification by specialty
Medicine in general Psychosomatic Internal Medicine Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine feasibility and preliminary effectiveness of the psychological support program by conducting retrospective observational studies at multiple institutions that carry out psychological support programs for AYA generation cancer patients under clinical setting.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Screening rate
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 AYA generation cancer patients
Key exclusion criteria non-AYA generation cancer patients
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Maiko
Middle name
Last name Fujimori
Organization National Cancer Center, Japan
Division name Division of Health Care Research, Behavioral Science and Survivorship Research Group, Center for Public Health Sciences
Zip code 1040045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL 03-3542-2511
Email mfujimor@ncc.go.jp

Public contact
Name of contact person
1st name Takatoshi
Middle name
Last name Hirayama
Organization National Cancer Center Hospital, Japan
Division name Department of Psycho-Oncology
Zip code 1040045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
TEL 03-3542-2511
Homepage URL
Email thirayam@ncc.go.jp

Sponsor
Institute National Cancer Center, Japan
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of National Cancer Center, Japan
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.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
2020 Year 12 Month 25 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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 28 Day
Date of IRB
2020 Year 07 Month 28 Day
Anticipated trial start date
2020 Year 07 Month 31 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research Institutes:
National Cancer Center Hospital, Japan
Nagoya City University Hospital
Nagoya medical Center
Shizuoka Cancer Center
Aichi Cancer Center
St Luke`s International Hospital
Saitama Children`s Medical Center
National Center for Child Health and Development

Management information
Registered date
2020 Year 12 Month 25 Day
Last modified on
2020 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048921

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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