UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036330 |
|---|---|
| Receipt number | 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 | 2023/03/09 09:35:30 |
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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
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
thirayam@ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
Institute
Department
Personal name
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
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
https://doi.org/10.1017/s147895152200092x
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1017/s147895152200092x
Number of participants that the trial has enrolled
40
Results
The feasibility, discriminant validity, and test-retest reliability of the Japanese version of the Distress Thermometer and Problem List for adolescent and young adult cancer patients were suggested.
Results date posted
| 2023 | Year | 03 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
adolescent and young adult cancer patients in Japan
Participant flow
A member of the research team approached potential participants at National Cancer Center Hospital to invite them to participate in this study and obtain written informed consent.
Adverse events
Nothing
Outcome measures
feasibility, discriminant validity, and test-retest reliability
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 25 | Day |
Other
Other related information
Data analysis for publication has been completed.
Management information
Registered date
| 2019 | Year | 03 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041392
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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