Vaccination Readiness and Decisional Role in Patients with Cancer: a multi-center, prospective, observational study(v-ARCH)

Vaccination Readiness and Decisional Role in Patients with Cancer: a multi-center, prospective, observational study(v-ARCH) - v-ARCH study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060975

Enrollment

210

Registered

2026-04-01

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
To clarify patients' roles in decision-making regarding influenza vaccination (Active, Collaborative, Passive) and to examine their association with vaccination readiness.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Japan

Contacts

Public ContactMoe Manabe

Tokyo Medical University Hospital Department of Pharmacy

moak315@tokyo-med.ac.jp03-3342-6111

Outcome results