UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056846 |
|---|---|
| Receipt number | R000064972 |
| Scientific Title | Evaluating the Use of a Video-assisted Informed Consent Tool "MediOS" to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/01/28 |
| Last modified on | 2025/01/31 16:39:28 |
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Basic information
Public title
Evaluating the Use of a Video-assisted Informed Consent Tool to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial
Acronym
Evaluating the Use of a Video-assisted Informed Consent Tool to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial
Scientific Title
Evaluating the Use of a Video-assisted Informed Consent Tool "MediOS" to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial
Scientific Title:Acronym
Evaluating the Use of a Video-assisted Informed Consent Tool to Reduce Decision Conflict in Gastric Cancer Surgery: A Single-Center Open-Label Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the impact of watching a video after preoperative informed consent on decisional conflict and IC time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Decisional Conflict Scale Score
Key secondary outcomes
Change in Informed Consent Time
Change in Total Time Required for Outpatient Consultations
Surgery-related Parameters: Operative Time, Blood Loss, Postoperative Complications
Exploratory Evaluation Items
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Pre-Consultation Video (PreVid) Group: Patients viewed the video before the face-to-face consultation with the surgeon.
Interventions/Control_2
Post-Consultation Video Group (PostVid) Group: Patients viewed the video after the physician's consultation.
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have provided written informed consent based on sufficient explanation, thorough understanding, and their own free will.
Patients aged 20 years or older but under 75 years at the time of consent.
Patients diagnosed with clinically resectable gastric cancer at stage I-III.
Patients scheduled for informed consent for elective surgery
Patients for whom the principal investigator or sub-investigators confirm that the attending physician can clearly present the treatment plan during the initial consultation based on prior diagnostic results.
Key exclusion criteria
Patients with a history of gastric cancer surgery (e.g., remnant gastric cancer patients).
Patients classified as Grade 3 or higher by the American Society of Anesthesiologists (ASA).
Patients are scheduled for neoadjuvant chemotherapy (NAC).
Patients with comorbid psychiatric disorders, psychological symptoms, or cognitive impairment, were deemed unable to participate in the study.
Patients or accompanying family members unable to operate the MediOS system.
Any other patients deemed unsuitable by the principal investigator or sub-investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Suda |
Organization
Fujita Health University
Division name
Department of Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-9254
ko-suda@nifty.com
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Shibasaki |
Organization
Fujita Health University
Division name
Department of Surgery
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-9254
Homepage URL
susumu.shibasaki@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
Same as above
Tel
-
irb-sys@fujita-hu.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
| 2025 | Year | 01 | Month | 28 | 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
60
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
| 2022 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 28 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064972
