Patients with cancer vary widely in their threshold for seeking help when their condition deteriorates or symptoms worsen. Many are stoic and are slow to recognize when it is time for an urgent intervention. The COVID-19 pandemic has magnified the negative outcomes that occur as a result of delaying necessary medical care.
"We noted early on in the COVID crisis that patients were slow to present for emergency care, arriving at the ER in dire condition with oxygen saturations in the as low as 60% to 70%," said John V. Heymach, MD, PhD, of The University of Texas MD Anderson Cancer Center.
In an effort to more effectively manage patients' care, improve outcomes, and avoid unnecessary trips to the clinic or hospital, researchers at MD Anderson are exploring ways to optimize remote monitoring.
Power of Patient-Reported Outcomes
Patient-reported outcomes (PROs), widely used in research, have been validated as an effective tool for helping healthcare providers better manage patient care. The MD Anderson Symptom Inventory (MDASI) is a multi-symptom PRO measure that applies broadly across cancer types and treatments. The inventory's 13 core symptom items include symptoms found to have the highest frequency and/or severity in patients with cancer undergoing a variety of treatment types. An additional six interference items seek to determine to what extent symptoms interfere with patients' daily activities. The symptom severity and amount of interference describe the symptom burden of a disease.
"During their clinic visits, patients might not always talk freely about how they are feeling. Most will, however, answer the questionnaire honestly," said Loretta A. Williams, PhD, APRN-CNS, of The University of Texas MD Anderson Cancer Center. "This tool gives clinicians a better, more focused way to gather symptom information and begin discussions during visits."
Leveraging this information to gauge patients' response to treatment and for triaging them to appropriate interventions has clear implications beyond cancer. The COVID-19 pandemic has spurred renewed interest in and acceptance of telehealth, making effective methods for remote patient monitoring more relevant than ever before. Questionnaires of this type are easily and automatically administered electronically.
At the same time, widely available Bluetooth-enabled devices allow patients to measure objective signs, such as temperature and oxygen saturation by pulse oximetry, at home, which can then be shared with caregivers for a complete picture of patients' health status. This information empowers healthcare providers in their clinical decision making. Needed treatments can be initiated sooner, and often patients can be spared unnecessary trips to physicians' offices or hospitals, protecting healthcare workers and other patients from potential exposure to infections such as COVID-19.
"We are seeking the perfect combination of collecting self-report symptom data and monitoring vital signs that can enhance care for [patients with] cancer specifically, and particularly those who may also test positive for COVID-19," said Susan K. Peterson, PhD, MPH, of The University of Texas MD Anderson Cancer Center. "We are studying this in a National Cancer Institute–funded investigation, the Combat COVID 19 Protocol." The team envisions their findings being applicable across other settings, patient groups, and conditions.
Proof PROs Improve Care
The MDASI was developed at MD Anderson in the late 1990s when it was recognized that patients with cancer experience many symptoms that were not routinely monitored.1 "We now have modules with relevant symptoms based on the particular cancer, treatment, or both," Dr. Williams said. "For the MDASI Lung Cancer, one of the added questions is cough, a common symptom for [patients with] lung cancer."2,3
Four years ago, the group began a registry of patients with advanced lung cancer, open to all those who are not on an investigational treatment. Patients complete the inventory every 6 weeks. "We have close to 900 patients we are studying now," Dr. Williams said. "In our analyses, we look at information such as how the symptoms vary as patients' disease responds or does not respond to treatment."
A pivotal study done at Memorial Sloan Kettering Cancer Center in the early 2000s confirmed the value of PROs for clinical care, and since then, their use has become increasingly common.4-6 In that investigation, a group of patients with advanced cancer on chemotherapy completing a symptom survey once a week via an automated phone system were compared to a group surveyed only at office visits. Patients who received weekly calls had better quality of life, fewer emergency room visits, and a lower hospitalization rate.
"They had fewer symptoms, better symptom management, and increased treatment adherence. At the 5-year follow-up, this group of patients had lived longer. The study was a game-changer in terms of the importance of administering PROs clinically," Dr. Williams said.
Adapting the MDASI for COVID-19
With COVID-19 increasing the urgency for home monitoring, MD Anderson added 11 common COVID-19 symptoms, developed from literature review and expert opinion, to the inventory. "We are working to expand home monitoring of PROs now coupled with objective data in [patients with] lung cancer because of their higher risk from COVID-19 and overlap in symptoms," Dr. Heymach said. "A large percentage of [patients with] lung cancer have shortness of breath, for example, so more detailed information needs to be collected."
MD Anderson collects patient data through its electronic health records system, but providing all patients with tablet devices would facilitate wider applicability. In the planned study, objective data from multiple Bluetooth-enabled home monitoring devices will be combined with the PRO information to monitor and track patients with lung cancer and those who are COVID-19 positive. Patients will be referred for additional care when needed, and investigators will analyze the data to determine what symptoms correlate with varying disease severity.
"Early on in our experience, we found that [patients with] cancer undergoing treatment are very motivated to engage in at-home monitoring," Dr. Peterson said. "Many of the devices used to collect vital signs in this context, like blood pressure cuffs, thermometers, pulse oximeters, and weight scales, are fairly straightforward and are designed for consumer use.”7
In a completed study, patients with head and neck cancer who received radiation treatment measured weight, blood pressure, and pulse once a day as well as completed a brief set of questions about symptoms relevant to dehydration.8 The information was transmitted in near real time through a monitored interface. "When warranted, clinicians contacted patients who [had] troublesome symptoms," Dr. Peterson said. "Compared with patients who [were] not monitored at home, remotely monitored patients had a better symptom profile and quality of life—a result that we see persisted for 4 to 6 weeks after treatment."
Patients also reported that that they felt extra cared for. "We were concerned about not having in-person contact with patients," Dr. Peterson said. "Instead, we have found that technology may allow us to establish an even more consistent and effective connection with patients that they feel adds value to their care. The combination of the MDASI self-report symptom measure and the home-based devices provides insight into patients’ experiences during treatment that we have not had previously."
The team sees remote monitoring eventually being accomplished using a smartphone and applications. "The push toward [telehealth] and the need for more robust home monitoring has really been accelerated due to COVID-19," Dr. Heymach said. "We believe we can keep patients and caregivers safer and relieve a significant burden on patients through video visits and improved at-home monitoring."
Remote monitoring also has the added benefit of making it easier for patients with lung cancer to participate in clinical research. "Our long-term vision is to collect more objective, useful data, along with symptom information, to improve outcomes for [patients with] lung cancer and save them from traveling in many instances," Dr. Heymach said. "It's a clear win for patients."
- Cleeland CS, Mendoza TR, Wang XS, et al. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer. 2000;89(7):1634-1646.
- Mendoza TR, Wang XS, Lu C, et al. Measuring the symptom burden of lung cancer: the validity and utility of the lung cancer module of the M. D. Anderson Symptom Inventory. Oncologist. 2011;16(2):217-227.
- Whisenant MS, Williams LA, Garcia Gonzalez A, et al. What Do Patients With Non-Small-Cell Lung Cancer Experience? Content Domain for the MD Anderson Symptom Inventory for Lung Cancer JCO Oncol Pract. 2020 Jun 15. [Epub ahead of print].
- Basch E, Deal AM, Dueck AC, et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA. 2017;318(2):197-198.
- Basch E, Deal AM, Kris MG, et al. Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol. 2016;34(6):557-565.
- Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of Patient-Reported Outcomes in Routine Medical Care. Am Soc Clin Onc Educ Book. 2018;38:122-134.
- Liao Y, Thompson C, Peterson S, Mandrola J, Beg MS. The Future of Wearable Technologies and Remote Monitoring in Health Care. Am Soc Clin Oncol Educ Book. 2019;39:115-121. doi:10.1200/EDBK_238919.
- Peterson SK, Shinn EH, Basen-Engquist K, et al. Identifying early dehydration risk with home-based sensors during radiation treatment: a feasibility study on patients with head and neck cancer. J Natl Cancer Inst Monogr. 2013;2013(47):162-168.