UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055391 |
|---|---|
| Receipt number | R000063298 |
| Scientific Title | Evaluation of a Novel Approach for Reducing Psychological Stress in Advanced Cancer Patients Using VR Environments |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2025/07/29 11:55:02 |
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Basic information
Public title
Evaluation of a Novel Approach for Reducing Psychological Stress in Advanced Cancer Patients Using VR Environments
Acronym
VR Stress Relief Development Trial (VR-SRDT)
Scientific Title
Evaluation of a Novel Approach for Reducing Psychological Stress in Advanced Cancer Patients Using VR Environments
Scientific Title:Acronym
VR Stress Relief Development Trial (VR-SRDT)
Region
| Japan |
Condition
Condition
Malignant Tumor
Classification by specialty
| Medicine in general | Gastroenterology | Psychosomatic Internal Medicine |
| Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To establish a novel framework for objectively evaluating the effects of a personalized virtual reality-based non-pharmacological intervention on psychological distress in cancer patients experiencing acute psychological stress immediately after being informed of their diagnosis, using blood-based molecular biomarkers such as miRNA and Klotho.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To establish a novel framework for objectively evaluating the effects of a personalized virtual reality-based non-pharmacological intervention on psychological distress in cancer patients experiencing acute psychological stress immediately after being informed of their diagnosis, using blood-based molecular biomarkers such as miRNA and Klotho.
Key secondary outcomes
To analyze changes in circulating miRNA and serum Klotho induced by VR experience, aiming to identify novel objective biomarkers for stress assessment.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Virtual reality-based non-pharmacological intervention
Interventions/Control_2
Without a Virtual reality-based non-pharmacological intervention
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. The patient has incurable cancer.
2. The patient is 20 years of age or older.
3. Informed consent for participation in the study has been obtained.
4. The patient does not have any psychiatric disorders.
5. The patient's pain is controlled (NRS score of 5 or less).
Key exclusion criteria
1. The attending physician has determined that the patient is ineligible for participation in the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Advanced Oncology
Zip code
7010192
Address
577, Matsushima, Kurashiki-city, Okayama
TEL
0864621111
takeshin@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Nagasaka |
Organization
Kawasaki Medical School
Division name
Advanced Oncology
Zip code
7010192
Address
577, Matsushima, Kurashiki-city, Okayama
TEL
0864621111
Homepage URL
takeshin@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Takeshi Nagasaka
Funding Source
Organization
Self-fund
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577, Matsushima, Kurashiki-city, Okayama
Tel
0864621111
sentan@med.kawasaki-m.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 | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study aims to evaluate the effectiveness of regularly experiencing MR (Mixed Reality) and VR (Virtual Reality) as a novel approach to reducing psychological and physical distress in terminal cancer patients. The evaluation will utilize scoring methods such as ESAS (Edmonton Symptom Assessment System) and HADS (Hospital Anxiety and Depression Scale) to measure patients' perceived pain and anxiety, as well as GSR (Galvanic Skin Response) to assess physiological stress responses. Additionally, a comprehensive analysis of changes in blood miRNA over time will be conducted.
Management information
Registered date
| 2024 | Year | 09 | Month | 01 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063298
