Clinical trial NCT04953065: Coronavirus Disease 2019 (COVID-19) Vaccination in Cancer Patients
Official title: COVID-19 Vaccination in Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignancies Multiple
Keywords: COVID-19
Cancer
Vaccination
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID-19 negative and COVID-19 positive adult cancer patients

Brief 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).

Eligibility criteria: 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:

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

Primary outcomes:
measure: Rate of COVID-19 vaccination in cancer population
timeFrame: 5 months
measure: Hesitancy to COVID-19 vaccination
timeFrame: 5 months
Secondary outcomes:
measure: rate of COVID-19 vaccination in two cohorts
timeFrame: 5 months
measure: Factors associated with vaccine-acceptance and vaccine-hesitancy
timeFrame: 5 months
measure: Side effects of COVID-19 vaccines
timeFrame: 5 months
measure: Effect of COVID-19 vaccines
timeFrame: 5 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Penn State Cancer Institute
name: Monika Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: