UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054691 |
|---|---|
| Receipt number | R000062408 |
| Scientific Title | Psychological Status of Patients Undergoing Cancer Genomic Profiling: Qualitative study |
| Date of disclosure of the study information | 2024/06/24 |
| Last modified on | 2024/12/20 12:08:44 |
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Basic information
Public title
Psychological Status of Patients Undergoing Cancer Genomic Profiling: Qualitative study
Acronym
Psychological Status of Patients Undergoing Cancer Genomic Profiling: Qualitative study
Scientific Title
Psychological Status of Patients Undergoing Cancer Genomic Profiling: Qualitative study
Scientific Title:Acronym
Psychological Status of Patients Undergoing Cancer Genomic Profiling: Qualitative study
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Nursing |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the psychological status of patients with cancer undergoing cancer genomic profiling
Basic objectives2
Others
Basic objectives -Others
Symptoms
Psychological Status
Effects on sleep
Motivation to take the test
Family reaction
Understanding of the explanation of the test
Support needs for medical staff
Prospects for life after the test - until the results are disclosed
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Psychological status of patients with cancer undergoing cancer genomic profiling
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Persons who have undergone cancer genomic profiling.
2) Persons who are able to hold a conversation lasting 30-60 minutes.
3) Persons who have given written consent to participate in the research.
4) Persons aged 18 years or older.
Key exclusion criteria
Persons for whom the principal investigator or principal investigator's assistant determines that a request for research is inappropriate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Takeda |
Organization
Mie University
Division name
Center for Medical and Nursing Education
Zip code
514-8507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-231-5260
ytakeda@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Takeda |
Organization
Mie University
Division name
Center for Medical and Nursing Education
Zip code
5148507
Address
2-174 Edobashi, Tsu City, Mie
TEL
059-231-5260
Homepage URL
ytakeda@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
JSPS
KAKENHI
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
the Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu City, Mie
Tel
059-231-5246
ytakeda@med.mie-u.ac.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 | 06 | Month | 24 | 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
| 2024 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Qualitative study
Management information
Registered date
| 2024 | Year | 06 | Month | 18 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062408
