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CompletedNCT04953065Updated May 9, 2024

Coronavirus Disease 2019 (COVID-19) Vaccination in Cancer Patients

An observational study in Malignancies Multiple, sponsored by Monika Joshi. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by Monika Joshi · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 89 Years
Sex
All
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Study 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. 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).

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Conditions studied

  • Malignancies Multiple

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Keywords

  • COVID-19
  • Cancer
  • Vaccination
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 130 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

This is the only study on the registry with Monika Joshi as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

COVID-19 negative and COVID-19 positive adult cancer patients

Inclusion criteria

  1. Current or past medical history of invasive malignancy (any type) that has been treated at PSCI
  2. Patients who are at least 18-years-old and younger than 90-years-old
  3. Patients need to have working telephone /ability to converse. Interpreter could be used to get help with survey if not English speaking.
  4. Patients who have had previous COVID-19 infection are also eligible.

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Patients who are under the age of 18 and older than 89-years-old
  3. Patients who cannot provide consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
Patient registry
No

Groups and cohorts

  • interventional

    Single arm, interventional. All participants will be contacted over the phone to answer questions from a COVID-19 vaccine hesitancy and acceptance survey.

    Other: COVID-19 vaccine hesitancy and acceptance survey

Interventions

  • OtherCOVID-19 vaccine hesitancy and acceptance survey

    Participants will be provided with a COVID-19 vaccine hesitancy and acceptance survey developed by the study team.

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What researchers measure

Primary outcomes

  1. Rate of COVID-19 vaccination in cancer population

    To estimate the rate of COVID-19 vaccination in the adult cancer population.

    Time frame: 5 months

  2. Hesitancy to COVID-19 vaccination

    To identify the reasons of participants' hesitancy to COVID-19 vaccination through questionnaire.

    Time frame: 5 months

Secondary outcomes

  1. rate of COVID-19 vaccination in two cohorts

    To determine the rate of vaccination in COVID-19 positive or COVID-19 negative cohorts

    Time frame: 5 months

  2. Factors associated with vaccine-acceptance and vaccine-hesitancy

    To quantify the percentage of patients who are vaccine-accepting or vaccine-hesitant

    Time frame: 5 months

  3. Side effects of COVID-19 vaccines

    To identify side effects of COVID-19 vaccines in vaccinated adult cancer patients

    Time frame: 5 months

  4. 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.

    Time frame: 5 months

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Study locations

1 site
  • Penn State Cancer Institute
    Hershey, Pennsylvania 17033, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04953065
Lead sponsor
Monika Joshi
Responsible party
Monika Joshi (Associate Professor, Hematology/Oncology, Milton S. Hershey Medical Center) — Sponsor-investigator
First posted
Jul 7, 2021
Start date
Aug 30, 2021
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023
Last update
May 9, 2024

Study contacts

Monika Joshi, MD
principal investigator · Penn State Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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