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

NCT04953065 | Completed DMC

• 1 other identifier: PSCI-21-100
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignancies Multiple

Keywords

COVID-19; Cancer; Vaccination

Outcome Measures

Primary Outcomes (2)

• Rate of COVID-19 vaccination in cancer population

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

  5 months

• Hesitancy to COVID-19 vaccination

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

  5 months

Secondary Outcomes (4)

• rate of COVID-19 vaccination in two cohorts

  5 months

• Factors associated with vaccine-acceptance and vaccine-hesitancy

  5 months

• Side effects of COVID-19 vaccines

  5 months

• Effect of COVID-19 vaccines

  5 months

Study Arms (1)

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

COVID-19 vaccine hesitancy and acceptance survey OTHER

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

interventional

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Monika Joshi: lead

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

COVID-19; Neoplasms

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Monika Joshi, MD

  Penn State Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Hematology/Oncology

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 7, 2021
• Study Start: August 30, 2021
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)