Malignancies MultipleNCT04953065
Coronavirus Disease 2019 (COVID-19) Vaccination in Cancer Patients
An observational study of Malignancies Multiple, run by Monika Joshi at 1 site in United States.
Trial summary
The current study primarily aims to determine the status of vaccination in enrolled cancer patients and identify barriers to coronavirus disease 2019 (COVID-19) vaccination in cancer patients who have not been vaccinated. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Malignancies Multiple
- What is being tested?
- COVID-19 vaccine hesitancy and acceptance survey
- Type of treatment
- Vaccines
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 31 Jan 2023
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COVID-19 negative and COVID-19 positive adult cancer patients
Who may be able to join
- Current or past medical history of invasive malignancy (any type) that has been treated at PSCI
- Patients who are at least 18-years-old and younger than 90-years-old
- Patients need to have working telephone /ability to converse. Interpreter could be used to get help with survey if not English speaking.
- Patients who have had previous COVID-19 infection are also eligible.
Who cannot join
- Patients who have not been treated or have been seen for current or past medical history of invasive malignancy (any type) at Penn State Cancer Institute
- Patients who are under the age of 18 and older than 89-years-old
- Patients who cannot provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
About this study
Official title: COVID-19 Vaccination in Cancer Patients
The current study primarily aims to determine the status of vaccination in enrolled cancer patients and identify barriers to coronavirus disease 2019 (COVID-19) vaccination in cancer patients who have not been vaccinated. Secondary objectives include determining the rate of vaccination in those who have ever been COVID-19 positive and those who have never been COVID-19 positive. The study team also seeks to determine factors associated with vaccine-acceptance and vaccine-hesitancy in the adult cancer population, identify side effects of COVID-19 vaccines in vaccinated cancer patients and to examine the effect of COVID-19 vaccination on overall clinical outcome in cancer patients. The study team will be conducting telephone interviews/surveys with up to130 adult cancer patients for data collection.
Read the detailed description
Currently, there is a void in literature regarding the rates of coronavirus disease 2019 (COVID-19) vaccination in cancer patients. The investigators aim to address this question by elucidating rates of vaccination in the general Penn State Cancer Institute (PSCI) patient population as well as patients from the COVID-19 and Cancer Consortium (CCC-19) who are known to have had previous COVID-19 infection. There is a wealth of information regarding the general population's uptake of COVID-19 vaccines, but there is not nearly as much information regarding cancer patients.
Multiple studies are seeking to find factors associated with COVID-19 vaccine hesitancy in the general population. There are very few published studies that have specifically examined factors associated with vaccine hesitancy (or barriers to vaccination) in cancer patients. The investigators aim to identify barriers to COVID-19 vaccination in the adult cancer population. Further, a comparison between vaccine acceptance and/or hesitancy in patients with prior known COVID-19 positivity and those without prior COVID-19 positivity has not been conducted yet, to the knowledge of the study team.
Additionally, the safety and efficacy profiles of COVID-19 vaccination in cancer patients has yet to be determined. Admittedly, the efficacy profile of COVID-19 vaccination is an ongoing process and situation. One study did determine that only 1 dose of the Pfizer-Biopharmaceutical New Technologies was not efficacious in producing positive anti-Spike protein titers 21 days after a single vaccine inoculum. Only 21 of 56 solid cancer patients and 8 of 44 hematological cancer patients sero-converted after a single dose. The general findings here were that patients with cancer need an early or day 21 second dose of the Pfizer vaccine in order for positive anti-S titers to be present in their blood. It is still unknown if these patients or those in the general population will require annual (or another time-frame) boosters.
This study does aim to establish a safety profile in those PSCI patients who have been vaccinated, as the investigators will be inquiring about side effects from vaccination. There is little information available about the safety profile of COVID-19 vaccination in cancer patients. The investigators will be asking participants about the side effects they may have experienced after vaccination.
One known side effect that may have an impact on cancer treatment and outcomes includes axillary and supraclavicular lymph node enlargement. According to this study, more patients who received the Moderna Inc. vaccine had ipsilateral axillary lymphadenopathy (lymph node enlargement in the same side that the vaccine was administered) than those who received the Pfizer vaccine. The investigators will be surveying patients to examine whether or not this phenomenon occurred in PSCI patients and what the outcome was (no change in treatment, delay in treatment, stoppage of treatment, for example).
- Conditions
- Malignancies Multiple
- Being tested
- COVID-19 vaccine hesitancy and acceptance survey
- Keywords
- COVID-19, Cancer, Vaccination
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 vaccine hesitancy and acceptance surveyOther
Participants will be provided with a COVID-19 vaccine hesitancy and acceptance survey developed by the study team.
| Study group | Role | What they receive |
|---|---|---|
| interventional | Single arm, interventional. All participants will be contacted over the phone to answer questions from a COVID-19 vaccine hesitancy and acceptance survey. Receives: Other: COVID-19 vaccine hesitancy and acceptance survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of COVID-19 vaccination in cancer population
To estimate the rate of COVID-19 vaccination in the adult cancer population.
Measured: 5 months
Hesitancy to COVID-19 vaccination
To identify the reasons of participants' hesitancy to COVID-19 vaccination through questionnaire.
Measured: 5 months
Secondary outcomes (4)
rate of COVID-19 vaccination in two cohorts
To determine the rate of vaccination in COVID-19 positive or COVID-19 negative cohorts
Measured: 5 months
Factors associated with vaccine-acceptance and vaccine-hesitancy
To quantify the percentage of patients who are vaccine-accepting or vaccine-hesitant
Measured: 5 months
Side effects of COVID-19 vaccines
To identify side effects of COVID-19 vaccines in vaccinated adult cancer patients
Measured: 5 months
Effect of COVID-19 vaccines
To measure the effect of COVID-19 by the delay in treatment or stoppage of cancer treatment due to side effects of vaccination for >1 week and/or disease progression linked to vaccine administration.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start30 Aug 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignancies MultipleStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monika Joshi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monika Joshi, Milton S. Hershey Medical Center
- Investigators
- Monika Joshi, MD, Principal investigator, Penn State Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953065
- Sponsor's protocol ID
- PSCI-21-100
- Status last verified
- May 2024
- First submitted
- 30 Jun 2021
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Vaccination in Cancer Patients
- ClinicalTrials.gov ID
- NCT04953065
- Acronym / sponsor ID
- PSCI-21-100
- Conditions
- Malignancies Multiple
- Keywords
- COVID-19, Cancer, Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Monika JoshiUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 7 Jul 2021 (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.
The current study primarily aims to determine the status of vaccination in enrolled cancer patients and identify barriers to coronavirus disease 2019 (COVID-19) vaccination in cancer patients who have not been vaccinated. Secondary objectives include determining the rate of vaccination in those who have ever been COVID-19 positive and those who have never been COVID-19 positive. The study team also seeks to determine factors associated with vaccine-acceptance and vaccine-hesitancy in the adult cancer population, identify side effects of COVID-19 vaccines in vaccinated cancer patients and to examine the effect of COVID-19 vaccination on overall clinical outcome in cancer patients. The study team will be conducting telephone interviews/surveys with up to130 adult cancer patients for data collection.
Detailed description
Currently, there is a void in literature regarding the rates of coronavirus disease 2019 (COVID-19) vaccination in cancer patients. The investigators aim to address this question by elucidating rates of vaccination in the general Penn State Cancer Institute (PSCI) patient population as well as patients from the COVID-19 and Cancer Consortium (CCC-19) who are known to have had previous COVID-19 infection. There is a wealth of information regarding the general population's uptake of COVID-19 vaccines, but there is not nearly as much information regarding cancer patients.
Multiple studies are seeking to find factors associated with COVID-19 vaccine hesitancy in the general population. There are very few published studies that have specifically examined factors associated with vaccine hesitancy (or barriers to vaccination) in cancer patients. The investigators aim to identify barriers to COVID-19 vaccination in the adult cancer population. Further, a comparison between vaccine acceptance and/or hesitancy in patients with prior known COVID-19 positivity and those without prior COVID-19 positivity has not been conducted yet, to the knowledge of the study team.
Additionally, the safety and efficacy profiles of COVID-19 vaccination in cancer patients has yet to be determined. Admittedly, the efficacy profile of COVID-19 vaccination is an ongoing process and situation. One study did determine that only 1 dose of the Pfizer-Biopharmaceutical New Technologies was not efficacious in producing positive anti-Spike protein titers 21 days after a single vaccine inoculum. Only 21 of 56 solid cancer patients and 8 of 44 hematological cancer patients sero-converted after a single dose. The general findings here were that patients with cancer need an early or day 21 second dose of the Pfizer vaccine in order for positive anti-S titers to be present in their blood. It is still unknown if these patients or those in the general population will require annual (or another time-frame) boosters.
This study does aim to establish a safety profile in those PSCI patients who have been vaccinated, as the investigators will be inquiring about side effects from vaccination. There is little information available about the safety profile of COVID-19 vaccination in cancer patients. The investigators will be asking participants about the side effects they may have experienced after vaccination.
One known side effect that may have an impact on cancer treatment and outcomes includes axillary and supraclavicular lymph node enlargement. According to this study, more patients who received the Moderna Inc. vaccine had ipsilateral axillary lymphadenopathy (lymph node enlargement in the same side that the vaccine was administered) than those who received the Pfizer vaccine. The investigators will be surveying patients to examine whether or not this phenomenon occurred in PSCI patients and what the outcome was (no change in treatment, delay in treatment, stoppage of treatment, for example).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional | – | Other: COVID-19 vaccine hesitancy and acceptance surveySingle arm, interventional. All participants will be contacted over the phone to answer questions from a COVID-19 vaccine hesitancy and acceptance survey. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COVID-19 negative and COVID-19 positive adult cancer patients
Key inclusion criteria (4 listed)
- Current or past medical history of invasive malignancy (any type) that has been treated at PSCI
- Patients who are at least 18-years-old and younger than 90-years-old
- Patients need to have working telephone /ability to converse. Interpreter could be used to get help with survey if not English speaking.
- Patients who have had previous COVID-19 infection are also eligible.
Key exclusion criteria (3 listed)
- Patients who have not been treated or have been seen for current or past medical history of invasive malignancy (any type) at Penn State Cancer Institute
- Patients who are under the age of 18 and older than 89-years-old
- Patients who cannot provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19 vaccine hesitancy and acceptance surveyParticipants will be provided with a COVID-19 vaccine hesitancy and acceptance survey developed by the study team. | Other | interventional |
Primary outcome
Rate of COVID-19 vaccination in cancer population
Time frame: 5 months
To estimate the rate of COVID-19 vaccination in the adult cancer population.
Hesitancy to COVID-19 vaccination
Time frame: 5 months
To identify the reasons of participants' hesitancy to COVID-19 vaccination through questionnaire.
4 secondary outcomes
rate of COVID-19 vaccination in two cohorts
Time frame: 5 months
Factors associated with vaccine-acceptance and vaccine-hesitancy
Time frame: 5 months
Side effects of COVID-19 vaccines
Time frame: 5 months
Effect of COVID-19 vaccines
Time frame: 5 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 9 May 2024.
- Individual participant dataSharing planned: No
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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.
Monika Joshi, MD principal investigator
Penn State Cancer Institute
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 Malignancies Multiple, run by Monika Joshi at 1 site in United States.
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 4 inclusion and 3 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 9 May 2024. 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 United States. 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?
Rate of COVID-19 vaccination in cancer population (time frame: 5 months). The study lists 2 primary outcomes in all. 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 9 May 2024.