As the United States took its first steps to roll out a COVID-19 vaccine in December, the American Society of Clinical Oncology (ASCO) released a comprehensive list of recommendations to strengthen cancer treatment and research during and beyond the coronavirus pandemic.
To foster implementation of the new recommendations, ASCO plans a number of advocacy and research initiatives, including releasing findings from its ASCO Survey on COVID-19 in Oncology Registry. As previously reported in Oncology Times, this registry is a clinical trial which collects baseline and longitudinal data on COVID-19's impact on cancer patient care, with the goal of improving that care.
The new recommendations are contained in ASCO's Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care. ASCO states its intention to “address long-standing cancer care disparities that have been highlighted by the pandemic.” The recommendations in the report, which were approved by ASCO's Board of Directors, were published in ASCO's Journal of Clinical Oncology.
Volunteer task forces of physicians, other cancer care professionals, and patient advocates developed the recommendations under the direction of ASCO Immediate Past President Howard A. “Skip” Burris, III, MD, FACP, FASCO. Burris is President of Clinical Operations and Chief Medical Officer of Sarah Cannon, as well as Executive Director for Drug Development for the research institute; he is also an associate of Tennessee Oncology.
Lessons learned from the pandemic can help strengthen the cancer care infrastructure, stressed ASCO President Lori J. Pierce, MD, FASTRO, FASCO, Professor and Vice Provost for Academic and Faculty Affairs at the University of Michigan and Director of the Michigan Radiation Oncology Quality Consortium.
“When the pandemic is over, patients deserve more than a return to the way things were before COVID-19,” said Pierce. “We have an opportunity to provide better care to everyone with cancer drawing from the insights we gained during the pandemic. Cancer care is marked by the same inequities as our society at large. To emerge from the pandemic stronger, we have to make sure every patient can benefit from advances in cancer research and care.”
The ASCO opinion survey showed that nearly six in 10 Americans believe racism can affect the health care someone receives, with African Americans and other minorities more likely to hold that view.
The detailed recommendations range from patient access to care to safe delivery of care, patient and provider well-being, support for oncology practices, and making clinical trials more efficient, flexible, and accessible to patients—such as using central institutional review boards. Highlights call for making expanded telemedicine coverage permanent; preventing Medicaid cuts; ensuring accessible, affordable, and comprehensive insurance plans; enhancing grants and other support for oncology practices in underserved areas; and sustaining federal safety net programs.
Some recommendations are directed specifically at Congress or the Centers for Medicare & Medicaid Services. The report containing the recommendations notes that the pandemic forced cancer care providers and researchers to adapt quickly. To date, most patients who were already in treatment have continued to receive treatment thanks to the rapidly escalating use of telemedicine and new COVID-19 safety protocols. Enrolled clinical trial participants have also been able to continue their participation.
However, the report shows that newly diagnosed patients have often faced delays in care and massive, potentially harmful disruptions to clinical trial enrollment and the launch of new trials, which provide access to promising new therapies. There are also marked concerns about delays in cancer screenings—delays which are projected to increase the U.S. death rate from cancer.
As previously reported in Oncology Times, recent results from the annual ASCO National Cancer Opinion Survey show that nearly two-thirds of Americans scheduled for a cancer screening during the pandemic reported that their cancer screening test was delayed or cancelled. Among those, two-thirds said it was their choice. The concern is that a significant number of Americans could stop getting cancer screenings for long periods of time or altogether, thus undercutting the benefits of screenings that detect cancer early, when it is most treatable.
“To a remarkable degree, we've weathered the pandemic with manageable disruptions in the care of existing patients,” said Burris. “But for newly diagnosed patients or those seeking clinical trials, it's been an especially difficult period. We owe it to patients to act on what we've learned, and to better support them now and after the pandemic had receded.”
Peggy Eastman is a contributing writer.
Strengthening Cancer Treatment & Research During COVID-19
The new ASCO recommendations include the following guidance to address cancer care disparities revealed during the COVID-19 pandemic.
Promoting access to and equity of cancer care.
- Increase the affordability of ACA-qualified health plans and abandon restrictive insurance products.
- Avoid cutting or restricting Medicaid as part of state-level pandemic responses.
- Expand opportunities for people to enroll in health insurance through the end of the pandemic.
- Protect social services programs—housing, nutrition, and others—that serve vulnerable patients.
Protecting patient safety during and beyond the COVID-19 pandemic.
- Create new chemotherapy infection control standards that account for viral threats like COVID-19.
- Limit home infusion to exceptional circumstances or clinical trials, when appropriate safety procedures are in place and benefits outweigh potential risks to patients.
- Ensure rapid approval of evidence-based alternate dosing schedules for cancer drugs to limit patient visits to infusion centers while pandemic protocols are in place.
- Ensure widespread, ethical distribution of COVID-19 testing, treatments, and vaccines.
- Replenish and strengthen the strategic national stockpile of personal protective equipment.
Ensuring that oncology practices have sufficient resources to preserve access to care.
- Expand grant and loan programs for oncology practices, with fewer restrictions and flexible terms to better meet the needs of practitioners.
- Allocate specific funds to practices and institutions serving underserved areas.
- Continue suspension of the federal budget sequester, which continues to threaten practices' ability to sustain critical patient services.
- Halt implementation of mandatory payment models that pose a financial risk to practices, potentially disrupting care delivery during the pandemic and recovery.
- Reform prior authorization and other utilization management policies.
Improving the quality and accessibility of telemedicine.
- Ensure robust reimbursement and coverage of telemedicine at the state and national level.
- Develop new products to inform guidelines, standards, and models that improve the quality of care.
- Create training for providers on delivering high-quality cancer care via telemedicine.
Addressing threats to the well-being of patients and providers.
- Provide access to behavioral health services, support groups, and psychiatric care for both patients and cancer care providers.
- Expand training for providers in communication skills, supportive and palliative care, and advance care planning.
- Increase reimbursement for supportive care, palliative care, and advance care planning.
- Clearly communicate public health precautions and guidance from federal, state, and local officials to oncology practices on a consistent basis.
Making clinical trials more efficient, flexible, and accessible to patients.
- Make permanent changes, adopted during the pandemic, that improve patient access to research (e.g., virtual consent with e-signatures, telehealth visits, and administration of treatment closer to participants' homes or at their homes); and increase the efficiency and flexibility of trials (e.g., virtual approaches to site selection, study implementation, and data collection).
- Design trials that are more efficient and better align with routine patients care (e.g., utilizing adaptive design elements and common control groups, and making trial visits/tests/schedules similar to routine clinical care).
- Require all study sponsors to recognize the same basic, non-study specific clinical trial training.
- Develop consensus on reporting and documentation requirements for site selection, protocol amendments and deviations, and other key aspects of clinical trials.
- Evaluate the impact of changes in clinical trial procedures and designs on participant diversity, patient safety, data quality, scientific integrity, and other key measures.
- Promote increased use of central institutional review boards (e.g., designing benefits and challenges to their use, and making recommendations for appropriate implementation and increased adoption).
- Develop guidance for the public release of non-peer-reviewed research to avoid confusion among patients, clinicians, and the public.