Cancer PatientsVENCT06872814
Vaccine Hesitancy in Patients with Solid Tumors: a Cross-sectional Single-center Survey
An observational study of Cancer Patients and Vaccine-Preventable Diseases, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
Cancer patients have a well-known and higher risk of vaccine-preventable disease (VPD) than the general population. VPD can cause serious complications due to compromised immune system, malnutrition and the same oncology treatments and represent a severe financial burden with a delay in treating the underlying cancer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients, Vaccine-Preventable Diseases
- How many people
- 309 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2024to 26 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population of this cross-sectional survey will include out-patients of the Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo Pavia
Who may be able to join
- >18 years of age;
- Oncology patient defined as a patient with solid tumors undergoing active systemic treatment or follow-up;
- Written informed consent
Who cannot join
- Patients with hematological tumors
- Patients who are unable to understand informed consent document
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SC Oncologia
Pavia, Pavia, 27100
About this study
Cancer patients have a well-known and higher risk of vaccine-preventable disease (VPD) than the general population. VPD can cause serious complications due to compromised immune system, malnutrition and the same oncology treatments and represent a severe financial burden with a delay in treating the underlying cancer The main purpose of this survey is to analyse the perception of cancer patients on the topic vaccines and vaccine-preventable diseases, the acceptability of vaccines and the evaluation of the determining factors associated with the choice of the patient to be vaccinated or not. This information will be used to improve the management of these issues.
- Conditions
- Cancer Patients, Vaccine-Preventable Diseases
- Medical subject headings
- Vaccine-Preventable Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the proportion of vaccinated subjects in our cohort of cancer patients undergoing active cancer treatment
The primary endpoint will be to assess the proportion of vaccinated subjects in the investigators cohort of cancer patients undergoing active cancer treatment (number of patients who received at least one vaccine/ total number of patients)
Measured: 3 months
Secondary outcomes (5)
assess the proportion of vaccinated subjects with the anti flu vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Measured: 3 months
assess the proportion of vaccinated subjects with anti SARS-CoV-2 vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Measured: 3 months
assess the proportion of vaccinated subjects with anti pneumococccal vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Measured: 3 months
assess the proportion of vaccinated subjects with anti HZ vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Measured: 3 months
assess which variables (sex, age, degree of education, marital state, commodities, type of tumor, type of oncological treatment) are associated with not willingness to receive vaccines
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start31 May 2024
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angioletta Lasagna, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872814
- Sponsor's protocol ID
- VE
- Acronym
- VE
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine Hesitancy in Patients with Solid Tumors: a Cross-sectional Single-center Survey
- ClinicalTrials.gov ID
- NCT06872814
- Acronym / sponsor ID
- VE / VE
- Conditions
- Cancer Patients, Vaccine-Preventable Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cancer patients have a well-known and higher risk of vaccine-preventable disease (VPD) than the general population. VPD can cause serious complications due to compromised immune system, malnutrition and the same oncology treatments and represent a severe financial burden with a delay in treating the underlying cancer The main purpose of this survey is to analyse the perception of cancer patients on the topic vaccines and vaccine-preventable diseases, the acceptability of vaccines and the evaluation of the determining factors associated with the choice of the patient to be vaccinated or not. This information will be used to improve the management of these issues.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of this cross-sectional survey will include out-patients of the Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo Pavia
Key inclusion criteria (3 listed)
- >18 years of age;
- Oncology patient defined as a patient with solid tumors undergoing active systemic treatment or follow-up;
- Written informed consent
Key exclusion criteria (2 listed)
- Patients with hematological tumors
- Patients who are unable to understand informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assess the proportion of vaccinated subjects in our cohort of cancer patients undergoing active cancer treatment
Time frame: 3 months
The primary endpoint will be to assess the proportion of vaccinated subjects in the investigators cohort of cancer patients undergoing active cancer treatment (number of patients who received at least one vaccine/ total number of patients)
5 secondary outcomes
assess the proportion of vaccinated subjects with the anti flu vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Time frame: 3 months
assess the proportion of vaccinated subjects with anti SARS-CoV-2 vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Time frame: 3 months
assess the proportion of vaccinated subjects with anti pneumococccal vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Time frame: 3 months
assess the proportion of vaccinated subjects with anti HZ vaccine in the investigators cohort of cancer patients undergoing active cancer treatment
Time frame: 3 months
assess which variables (sex, age, degree of education, marital state, commodities, type of tumor, type of oncological treatment) are associated with not willingness to receive vaccines
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients and Vaccine-Preventable Diseases, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the proportion of vaccinated subjects in our cohort of cancer patients undergoing active cancer treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.