UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060975 |
|---|---|
| Receipt number | R000069774 |
| Scientific Title | Vaccination Readiness and Decisional Role in Patients with Cancer: a multi-center, prospective, observational study(v-ARCH) |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/31 23:46:04 |
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Basic information
Public title
Vaccination Readiness and Decisional Role in Patients with Cancer: a multi-center, prospective, observational study(v-ARCH)
Acronym
v-ARCH study
Scientific Title
Vaccination Readiness and Decisional Role in Patients with Cancer: a multi-center, prospective, observational study(v-ARCH)
Scientific Title:Acronym
v-ARCH study
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on patient decision-making regarding influenza vaccination, aiming to clarify patients' roles in the decision-making process (Active, Collaborative, Passive) and to examine their association with vaccination readiness.
Basic objectives2
Others
Basic objectives -Others
It explores the relationship between regret following past vaccination-related decisions and actual vaccination behavior.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To clarify patients' roles in decision-making regarding influenza vaccination (Active, Collaborative, Passive) and to examine their association with vaccination readiness.
Key secondary outcomes
Estimation of the proportions of actual and preferred roles (Active, Collaborative, Passive) based on the Control Preference Scale (CPS) at the time of decision-making regarding vaccination.
Estimation of the agreement proportion and agreement coefficient between actual and preferred CPS roles (Active, Collaborative, Passive) at baseline.
Estimation of the total score and domain-specific scores of the 7C scale.
Estimation of the proportion of patients with high vaccination readiness, defined as a total 7C score of 4.02 or higher.
Comparison of DRS scores across groups defined by CPS roles and concordance/discordance of roles at baseline.
Comparison of each 7C domain score across groups defined by CPS roles and concordance/discordance of roles at baseline.
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.Age 18 years or older
2.Diagnosed with a solid tumor
3.Currently receiving or scheduled to initiate treatment with a regimen including cytotoxic anticancer agents or Antibody-Drug Conjugate
4.Provided written informed consent
Key exclusion criteria
1.Cognitive impairment that precludes completion of the PRO questionnaire
2.Psychiatric or psychological conditions that preclude completion of the PRO questionnaire
3.Native language is not Japanese
4.Already received the seasonal influenza vaccine for the current season
5.Unable to complete ePRO using a Bring Your Own Device (BYOD)
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Atushi |
| Middle name | |
| Last name | Sofuni |
Organization
Tokyo Medical University Hospital
Division name
Department of Clinical Oncology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
a-sofuni@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Moe |
| Middle name | |
| Last name | Manabe |
Organization
Tokyo Medical University Hospital
Division name
Department of Pharmacy
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
moak315@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University Hospital
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
Medical Ethics Review Committee of Tokyo Medical University
Address
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
Tel
03 - 3351 - 6141
IRB@tokyo-med.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
| 2026 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Diseases that can be prevented by vaccination, including influenza, are referred to as Vaccine-Preventable Diseases (VPDs). In Japan, however, vaccination coverage remains suboptimal. Several factors have been suggested to contribute to the low vaccination rates, including insufficient awareness of the necessity of vaccination, widespread misconceptions regarding vaccine efficacy and safety, and the presence of out-of-pocket costs for certain vaccines .
Among patients with cancer, additional challenges exist. For example, difficulties in determining the appropriate timing of vaccination in relation to cancer treatment, as well as challenges in distinguishing vaccine-related adverse events from treatment-related symptoms, may contribute to hesitancy toward vaccination.
Management information
Registered date
| 2026 | Year | 03 | Month | 18 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069774
