UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045779 |
|---|---|
| Receipt number | R000052264 |
| Scientific Title | Single center prospective observational peer support study of preliminary usefulness for anxiety in AYA generation cancer patients |
| Date of disclosure of the study information | 2021/10/17 |
| Last modified on | 2023/10/18 15:40:55 |
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Basic information
Public title
Single center prospective observational peer support study of preliminary usefulness for anxiety in AYA generation cancer patients
Acronym
Peer support study of AYA generation cancer patients
Scientific Title
Single center prospective observational peer support study of preliminary usefulness for anxiety in AYA generation cancer patients
Scientific Title:Acronym
Peer support study of 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
This study is a single-center, prospective observational study of the preliminary usefulness of the peer support "AYA Hiroba" held at the National Cancer Center Hospital Patient Support Center for anxiety in AYA generation cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospital Anxiety and Depression Scale-Anxiety (HADS-A)
Key secondary outcomes
Distress Thermometer(DT)
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
Cancer patients of the AYA generation who participated in the peer support "AYA Hiroba"
Key exclusion criteria
not applicable
Target sample size
24
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
国立がん研究センター中央病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.liebertpub.com/doi/10.1089/jayao.2023.0065
Publication of results
Published
Result
URL related to results and publications
https://www.liebertpub.com/doi/10.1089/jayao.2023.0065
Number of participants that the trial has enrolled
24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 13 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 13 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Published(https://www.liebertpub.com/doi/10.1089/jayao.2023.0065)
Management information
Registered date
| 2021 | Year | 10 | Month | 17 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052264
