The COVID-19 pandemic has had an outsized impact on individuals with underlying social and medical vulnerability, leading to increased rates of severe disease, hospitalization, and death in these groups. Participants with underlying immune compromise, such as those with multiple myeloma, represent one such group. The advent of vaccines against SARS-CoV-2 has significantly limited morbidity and mortality across all groups, but the effectiveness of vaccination in individuals who are less likely to mount sufficient antibody response is uncertain. For this reason, booster vaccines have been recommended for those with underlying immune compromise. However, several key gaps remain in our understanding of how to best protect these individuals. There is a dearth of real-world evidence about the effectiveness of vaccination and boosters in patients who are immunocompromised, and very little information specifically about the recently approved mRNA boosters. Additionally, rates of vaccination and booster uptake in the United States remain low. A rapid, decentralized method of ascertaining information related to booster vaccine response and adverse events related to vaccines and COVID-19 infection is critical not only to answer questions about the booster vaccines, but to develop an infrastructure for answering similar questions about future vaccines or other diseases.
The purpose of this project is to implement and establish the feasibility of a decentralized real-world evidence study network for patients with multiple myeloma and to monitor outcomes related to COVID-19 infection in this immunosuppressed population. Subjects with multiple myeloma will be invited to participate. The electronic portal will handle all consenting activities. Participants will be asked to complete specific study procedures electronically, including permission for electronic health record (EHR) data transfer. Participants will be asked to complete electronic questionnaires periodically.
Study Type
OBSERVATIONAL
Enrollment
201
Patients will be asked to complete baseline, 30-day, and 6-month clinical and patient reported outcome health surveys.
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC-Chapel Hill
Chapel Hill, North Carolina, United States
Feasibility of Obtaining Baseline Clinical and PRO Data Capture From 200 Consented Patients.
Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Time frame: At Baseline
Feasibility of Obtaining 30-day Clinical and PRO Data Capture From 200 Consented Patients.
Proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Time frame: 30 days after enrollment
Feasibility of Obtaining 6-month Clinical and PRO Data Capture From 200 Consented Patients.
proportion of consented participants who provide responses for the PRO instruments \& proportion of participants who permission access to clinical data through the EHR.
Time frame: 6 months after enrollment
COVID Vaccine Prevalence
Percent of patients who enroll on the study platform who had previously received a SARS-CoV-2 booster
Time frame: At Baseline
COVID Booster Incidence
Percent of patients who enroll on the study platform who went on to receive a SARS-CoV-2 booster at 1 month follow up visit
Time frame: 30 Days after enrollment
PRO Review
Among participants providing PROs, percentage for whom PROs were viewed by site personnel
Time frame: During 6 month study period
COVID-19 Infection Baseline
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
Time frame: At Baseline
COVID-19 Infection on Study
Percentage of participants reporting COVID-19 infection confirmed by home-based or other testing
Time frame: During 6 month study period
Patient Reported COVID 19 Related Outcomes at Baseline
Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization).
Time frame: At Baseline
Patient Reported COVID 19 Related Outcomes on Study
Patient reported outcomes related to confirmed COVID-19 infection. COVID-19-related outcomes were assessed through a decentralized approach using patient-reported data collected via study questionnaires. Outcomes included participant-reported COVID-19 infection and related clinical events (e.g., hospitalization).
Time frame: During 6 month study period
EHR COVID 19 Related Outcomes Baseline
Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR.
Time frame: At Baseline
EHR COVID 19 Related Outcomes on Study
Hospitalization related to COVID-19 was ascertained through electronic health record (EHR) data obtained with participant permission. COVID-19-related outcomes included COVID-19 infection and associated clinical events (e.g., hospitalization), as documented in the EHR.
Time frame: During 6 month study period
COVID Booster Incidence
Percent of patients who enrolled on the study platform and subsequently received a SARS-CoV-2 booster by the 6-month follow-up visit. Booster vaccination status was assessed using a combination of patient-reported data collected through the study platform and available electronic health record (EHR) data
Time frame: 6 months after enrollment
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