Tokyo, April 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060975) titled 'Vaccination Readiness and Decisional Role in Patients with Cancer: a multi-center, prospective, observational study(v-ARCH)' on April 1.
Study Type:
Observational
Primary Sponsor:
Institute - Tokyo Medical University Hospital
Condition:
Condition - Solid tumor
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
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 Size - 210
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069774
Disclaimer: Curated by HT Syndication.
