ASCO Registry to Help Close the COVID-19 Data Gap

May 29, 2020

During Pandemic, Learning From Every Patient Is Even More Critical

By Rachel Martin, ASCO Communications

Since January 2020, when the first confirmed case of COVID-19 was reported in the United States, nearly every part of society has experienced disruption: schools closed, shops and restaurants shuttered their doors, and the health care system experienced strain as it grappled with a pandemic unlike anything we’ve seen in modern times. For cancer care, specifically, routine screening and diagnostic testing dramatically declined, enrollment in many cancer clinical trials slowed to a halt, and some patients deferred treatment to lessen their risk of exposure.

Jerome Seid, MD, an oncologist at Great Lakes Cancer Management Specialists, said that COVID-19 has brought a number of changes to his practice. At the start of the pandemic, his practice began screening patients  before their visits, and except in certain circumstances, required patients to come in unescorted. The practice, which has five offices spread across a large geographic area in the suburbs of Detroit, has significantly modified most of its waiting rooms. Patients wait in their cars outside of the offices so that there is usually just one patient in the waiting room at a time. Many visits are being conducted by telemedicine, which, Dr. Seid said, presents its own challenges.

“A number of the patients in my community don’t have computer access or are not computer savvy enough to understand video chat options, so they prefer to defer care,” Dr. Seid said. “It’s also harder to explain things to patients over the phone. It can be more challenging to discuss an image or walk them through a website. And there are some parts of cancer care that are better discussed in person, where the nuance of the patient-physician relationship comes through.”

The biggest challenge, Dr. Seid says, has been determining how best to alter practice operations in response to the pandemic.

“We've been making changes to our operations based on the changing guidelines coming from the CDC [U.S. Centers for Disease Control and Prevention], and from Ascension Health System, with whom we partner, but trial and error has also helped us refine our office procedure,” Dr. Seid said. “Oncologists need guidance on what to do and how to do it so that we understand what elements of oncology practice can be changed safely, so that we can be confident that we’re not risking patient welfare. We don’t want to feel as if we’re battling the COVID-19 pandemic alone.”

ASCO Registry: Gathering Information on Two Fronts

Although ASCO had been hearing anecdotal information from members in the early months of 2020, there wasn’t any hard data from the United States that could guide oncologists with their decision-making. And, there is still much about COVID-19 and its impact on cancer care and outcomes that is unknown.

To address this critical need for information, ASCO recently launched the ASCO Survey on COVID-19 and Oncology Registry (ASCO Registry), which aims to help the cancer community learn more about the patterns of symptoms and severity of COVID-19 among patients with cancer, as well as how COVID-19 is impacting the delivery of cancer care and patient outcomes. The ASCO Registry is designed to collect both baseline and follow-up data on how the virus impacts cancer care and patient outcomes during and after the COVID-19 pandemic.

The initiative was launched after ASCO received inquiries from across the oncology community about how to adjust cancer care in the face of the pandemic. (Learn more about ASCO’s response to COVID-19.)

“Our members wanted to know what treatment plans were safe to proceed with, which treatments should be postponed, and how to organize their practice to make it safe for patients,” said ASCO chief medical officer and executive vice president Richard L. Schilsky, MD, FACP, FSCT, FASCO. “We decided that the best approach was to have our members tell us about their experiences directly so that we can understand how the virus has affected cancer care, both at the level of the practice and the level of the patient.”

To accomplish that two-tiered approach, the ASCO Registry collects two types of data: the first is at the practice level, which focuses on steps practices have taken to protect the safety of patients and staff during the public health crisis. Practices are asked about how they are prioritizing certain types of patients, if and how they are screening patients for exposure to COVID-19, and how practice workflows have changed, among other related questions on practice operations. The second tier of data collection is focused on the impact of the virus on individual patients with cancer who have a COVID-19 diagnosis. For example, for each patient, the Registry asks for data on comorbidities, the type of treatments patients have taken for COVID-19, disruptions to cancer treatments, if the patient has been hospitalized or intubated, and ultimately, their outcomes.

Once sufficient patient data have been received and analyzed, ASCO will deliver periodic reports to the cancer community and the broader public on key learnings, such as characteristics of patients with cancer most impacted by COVID-19, estimates of disease severity, treatment modifications or delays, implementation of telemedicine in the cancer treatment setting, and clinical outcomes among patients related to both COVID-19 and cancer. ASCO also plans to develop peer-reviewed manuscripts based on the data provided.

“Since it’s anticipated that there will be waves or spikes of infection, we hope this information can help practices be better prepared,” said Dr. Schilsky. “We also hope to learn if some changes should be preserved as routine care going forward because they actually improve outcomes or save time or money for patients or practices.”

Collaborating With Other Stakeholders

Given the need for data on COVID-19’s impact on cancer care and outcomes, several other organizations have launched single-institution and multisite registries. Each of these registries has a different focus and timeline, so participating in multiple registries will not compromise ASCO’s efforts or prevent organizations from working together. All of these efforts are vital to document and learn from the experience of patients with cancer with COVID-19.

ASCO is also pleased to have the support of other oncology societies, including the Oncology Nursing Society and the Association of Community Cancer Centers (ACCC). Both organizations are enthusiastically supporting the ASCO Registry by encouraging their members to share practice and patient information so that the cancer community can learn from a large data set that represents a diverse population of patients and practices from across the United States.

"In response to COVID-19, it is critical the we not only learn from every patient, but that we also learn from each other," said ACCC president Randall A. Oyer, MD. "ACCC urges providers to contribute to the ASCO Registry. By working together, we will develop the large data set needed to generate the research-based evidence that will help us best care for our patients, our health care workforce, and our communities."

ONS is pleased to support the ASCO Registry and strongly encourages our members’ participation. The registry provides the potential to answer important questions about COVID-19 in people with cancer which may lead to better outcomes as the pandemic continues,” said ONS president Nancy Houlihan, MA, RN, AOCN.

Enroll in the ASCO Survey on COVID-19 and Oncology Registry

The ASCO Registry is open to all U.S. oncology practices, including physician-owned, academic, and hospital/health system-owned practices, and hospitals (regardless of whether they have a cancer focus). To help defray the costs of research data entry, Conquer Cancer, the ASCO Foundation, is fundraising to enable ASCO to provide modest funding to participating practices.

Already, the Registry has collected data on 25 patients with cancer with a COVID-19 diagnosis. ASCO plans to release its first report on its findings later this summer.

“Particularly since there is so little information about the impacts of this pandemic, we hope every oncology provider will participate in this Registry so that we can learn from the experience of every patient,” Dr. Schilsky said.

Dr. Seid’s practice was one of the first to sign up for the ASCO Registry. “I’m trying to do whatever I can to help my own practice make decisions to help keep our patients safe,” he said. “The ASCO Registry is one way for us to understand how we stack up and share what we’re doing, in case it’s helpful to other practices. During this time of uncertainty, I believe we have an obligation to share our experiences.”

Practices that wish to enroll in the ASCO Registry should enter contact information and view the research participation and data use agreement (DUA). After reviewing the study schema, DUA, and central Institutional Review Board (IRB) exemption letter, interested practices should submit the completed research participation and data use agreement to CENTRA@asco.org. ASCO can modify the agreement to accommodate changes required by state law but prefers to execute the agreement with minimal changes to speed the review process and limit administrative expenses. 

Practices will complete an initial survey about the effects of the COVID-19 pandemic on their practice. After this survey, practices will enter baseline and follow-up data on patients with cancer who have confirmed COVID-19 disease. Follow-up data includes information on COVID-19 and cancer treatment and outcomes. Ideally, data entry will be performed on a routine basis, and practices will attempt to include information from inpatient hospitalizations. Practices may be asked to answer the survey regarding changes to their practice a few times over the course of the pandemic.

The ASCO Registry is an acceptable clinical trial registry for the attestation of the high-weighted practice Improvement Activity (IA), “COVID-19 Clinical Trials Related to the Emergency Response & Preparedness,” under Medicare’s Merit-based Incentive Payment System (MIPS).

Support Conquer Cancer, the ASCO Foundation's COVID Impacts Cancer fund.


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