Coronavirus Disease 2019 (COVID-19) Vaccination in Cancer Patients
Condition: Malignancies Multiple
MeSH terms: COVID-19
Study type: Observational

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.
    

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).
    

Intervention name(s): COVID-19 vaccine hesitancy and acceptance survey
Intervention type(s): Other
Intervention description(s): Participants will be provided with a COVID-19 vaccine hesitancy and acceptance survey developed by the study team.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        COVID-19 negative and COVID-19 positive adult cancer patients
      
Keywords: COVID-19; Cancer; Vaccination