UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054386 |
|---|---|
| Receipt number | R000062122 |
| Scientific Title | A single-center prospective observational study to explore the psychosocial needs and their timing of onset in AYA cancer patients. |
| Date of disclosure of the study information | 2024/05/13 |
| Last modified on | 2025/05/14 23:35:34 |
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Basic information
Public title
A single-center prospective observational study to explore the psychosocial needs and their timing of onset in AYA cancer patients.
Acronym
A single-center prospective observational study to explore the psychosocial needs and their timing of onset in AYA cancer patients.
Scientific Title
A single-center prospective observational study to explore the psychosocial needs and their timing of onset in AYA cancer patients.
Scientific Title:Acronym
A single-center prospective observational study to explore the psychosocial needs and their timing of onset in AYA cancer patients.
Region
| Japan |
Condition
Condition
Adolescents and Young Adults with Cancer
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore changes over time in the psychosocial support needs of AYA cancer patients immediately following their cancer diagnosis.
Basic objectives2
Others
Basic objectives -Others
Exploring changes over time in psychosocial support needs of AYA cancer patients
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distress Thermometer (Before the start of treatment, 1 month, 3 months, 6 months after the start of treatment)
Key secondary outcomes
Number and content of screening tool checklist items
Professional support intervened within 6 months of treatment initiation
Patient's medical and social background
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
| 16 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with a clinically or histologically confirmed diagnosis of cancer (including blood cancer)
2) Patients aged 16-39 years who are attending or hospitalized at the National Cancer Center Hospital
3) Patients who have not started their first treatment at the time of consent
Key exclusion criteria
1) clinically evident cognitive impairment
2) Severe physical symptoms that are judged by the treating physician or investigator to be inappropriate for participation in the study
3) Patient has serious psychiatric symptoms that the physician or investigator determines are not appropriate for participation in the study.
4) Inability to understand the contents of the explanation and consent document
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroto |
| Middle name | |
| Last name | Ishiki |
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
hishiki@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Yanai |
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
yyanai@ncc.go.jp
Sponsor or person
Institute
National Cancer Center, Japan
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
National Cancer Center IRB office
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
| 2024 | Year | 05 | Month | 13 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Subjects: AYA cancer patients undergoing inpatient and outpatient treatment at our hospital
Measurements: distress thermometer, screening tool
Management information
Registered date
| 2024 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062122
