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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036330
Receipt No. R000041392
Scientific Title Semi-structured interviews to validate the screening sheet for Japanese adolescent and young adult patients with cancer based on NCCN Distress Thermometer and Problem List
Date of disclosure of the study information 2019/03/28
Last modified on 2019/03/28

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Basic information
Public title Development of the screening sheet for Japanese adolescent and young adult patients with cancer
Acronym Development of the screening sheet for Japanese AYA patients with cancer
Scientific Title Semi-structured interviews to validate the screening sheet for Japanese adolescent and young adult patients with cancer based on NCCN Distress Thermometer and Problem List
Scientific Title:Acronym Semi-structured interviews to validate the screening sheet for Japanese AYA patients with cancer
Region
Japan

Condition
Condition Japanese adolescent and young adult patients with cancer
Classification by specialty
Medicine in general Adult Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to develop a screening sheet specifically for Japanese AYA patients with cancer.
Basic objectives2 Others
Basic objectives -Others Development of a screening sheet
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We plan to qualitatively analyze the obtained data from semi-structured interviews and to develop a screening sheet for Japanese AYA patients 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)15-39 years old
2)the patients in National Cancer Center Hospital in Japan
3)histologically diagnosed cancer patients when they were 15-39 years old
Key exclusion criteria 1)serious mental symptoms
2)They can`t communicate in Japanese language
3)serious cognitive functional disorders
4)the physicians in charge judge it difficult for their patients to participate in the program

Target sample size 40

Research contact person
Name of lead principal investigator
1st name Eriko
Middle name
Last name Satomi
Organization National Cancer Center Hospital, Japan
Division name Department of Palliative Medicine
Zip code 1040045
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email esatomi@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, Japan
TEL 03-3542-2511
Homepage URL
Email thirayam@ncc.go.jp

Sponsor
Institute National Cancer Center, Japan
Institute
Department

Funding Source
Organization National Cancer Center, Japan
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 03 Month 28 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
2019 Year 02 Month 08 Day
Date of IRB
2019 Year 03 Month 01 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2020 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The registrations are going well.

Management information
Registered date
2019 Year 03 Month 28 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041392

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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