Providing personalized and precision oncology requires an exact understanding of the cancer and the patient’s overall health condition. While much of our work at CSI-Cancer is focused on the cancer, we have identified a series of technical solutions to address challenges in current clinical health assessments. We define those solutions as the Digital Health Companion as these solutions support the patient’s journey.
Our scientific discovery underpinning the Digital Health Companion pointed us to the need to objectively assess the patient’s health performance status. This is currently done in the physician’s office during the initial consultation when broadly speaking, the physician watches the patient as they move from the chair to the exam table. It is that movement together with patient interview questions that becomes the performance status score in the health chart to decide on fitness for specific treatments. To replace this subjective Physician assessment, we have developed a data-driven solution that provides an objective measure of the health performance status by utilizing 3D cameras at the clinic and movement trackers at home. This work was both published in the scientific literature and has received prominence at both public audiences, including a demonstration at the White House event South by South Lawn, and scientific audiences, including the opening plenary lecture at the largest annual cancer research conference, the American Association of Cancer Research. Through these efforts, we developed a path of building both the science and the implementation of clinical care for patients, which we call the Digital Health Companion.
We have implemented Digital Health Companion technology to support several patient clinical trials to objectively assess human performance. Currently we have four clinical trials enrolling cancer patients undergoing therapy who are at risk of failing health due to both the drug therapy and their overall health performance – our goal is to both predict and prevent health failure and decipher the relationship between overall health and drug related challenges.
These Digital Health Companion technologies will enable better outcomes for patients at a reduced cost to the healthcare system through digital biomarkers.
ATOM-HP
The Analytical Tools to Objectively Measure Human Performance (ATOM-HP) was a pilot project aimed at quantifying PS to complement the current clinical assessment. A more objective evaluation of PS was obtained by tracking routine activities with consumer-grade biometric sensors and cameras and translating them into quantitative performance measures. In addition, an app designed for daily patient symptom reporting from a cell phone was used to collect daily ratings of fatigue, appetite, physical activity, sleep disturbance, and body weight.
ATOM-HP Primary Objectives:
- Identify predictors of Hospitalization / Urgent interventions/ Dose Delays (Mission Failure)
- Identify predictors of performance status score
- Identify predictors of fatigue score
ATOM-HP was led by Dr. Jorge Nieva in Medical Oncology, Dr. Cyrus Shahabi in Computer Science, Dr. Joan Broderick in Social Science and Dr. Peter Kuhn in Physics Oncology with joint support from the National Cancer Institute and the Department of Defense.
Op-Ed by Peter Kuhn: The Hill
News Coverage: NBC4 News by Mekahlo Medina
USC News: Mapping Cancer
“The more than 30,000 minutes between visits are a missed opportunity. Technology can be leveraged to fill this gap and provide a comprehensive picture. The collected data can lead to better treatment decisions, better survival rates, and better understanding between physician and patient. One of the great barriers to solving the complicated cancer puzzle is a lack of timely information. Having access to real-time data will be invaluable for scientists.”
PrecisionPS – Building on ATOM-HP
Our ongoing scientific discovery program requires the simultaneous research and development of new modules in the digital health companion. Trial 2 is that enablement as the trial on Movement and Fitness Trackers in Determining Performance Status (NCT03971266) at Norris Cancer Center at USC, Dr. Nieva PI and builds upon the insights and performance status measures obtained in the ATOM-HP project.
Critically, we need to work with other cancer centers to establish the use of the Digital Health Companion tools in other and specific settings of cancer care. Trial 1 is the Performance Status Assessment in Stage I-III Triple Negative Breast Cancer Patients Receiving Neoadjuvant Chemotherapy (NCT04835597) jointly with our colleagues at the MD Anderson Cancer Center in Houston, TX.
We are using a whole range interconnected sensors and devices to continually monitor the well-being of patients. With data collected from symptom monitoring and objective measures, we can create a safety net for cancer patients at home.
Watch Video: Kinect Data Feed
Objectively Measuring Performance
PrecisionPS combines the Microsoft Kinect, Microsoft Band, and the FitBit Scale to give comprehensive information. We collect data through clinical trials of outpatient monitoring with IoT devices and 3D-motion-capture of performance tests.
XFBD
Pilot Trial of XFBD, a TCM, in Persons with COVID-19 (NCT04810689) was a phase IIb clinical trial to evaluate a traditional Chinese medicine prescription called Xuanfei Baidu Granules in preventing the worsening of COVID-19 in the community setting. During the COVID-19 pandemic, the isolation policies prevented traditional methods of recruiting and enrolling patients in clinical trials. Utilizing our previous experience in remote technologies, this study utilized a tailored phone application to consent, monitor, and follow up on participants of the study in a decentralized model.
CSI-Cancer worked in collaboration with Dr. Zhang Boli, president of the Tianjin University of Traditional Chinese Medicine, to gain FDA Investigational New Drug approval; colleagues at the USC Norris Comprehensive Cancer Center and in the Preventive Medicine department to receive USC IRB approval and initiate the study; and Fulgent Genetics to provide COVID-19 testing.
“We believe that by utilizing our [next-generation sequencing] expertise along with our knowledge of the evolution and treatment of COVID-19 in China, we have contributed insightful and actionable data to the development of XFBD.”
ATEZO
The ATEZO trial is an ongoing clinical trial in collaboration with Genentech, Inc and supported by National Cancer Institute (NCI). It’s a feasibility study to determine how well the participants manage the devices, questionnaires and interactions to understand compliance and issues to improve subsequent studies. An additional goal is to monitor patients on treatment at home to potentially predict adverse events.
Our most advanced and most critical trial to enable the most advanced patient care for all patients. While many of most advanced drugs require the patient to visit a cancer center at a regular schedule (often weekly). However, it would have great advantages if instead the drug could travel to the patient’s home, which is the goal of this trial. This requires both the development of the necessary Digital Health Companion toolset to provide that support at home and drug formulations that are amenable to that approach. We built the former and Genentech built the latter by reformulating their most advanced immune oncology drug Tecentriq (atezolizumab) so that it can be administered subcutaneously instead of intravenously. Trial 4 is a Phase II study of subcutaneous atezolizumab in NSCLC patients, using a decentralized clinical trial model (NCT05340309) funded by Genentech, Dr. Nieva PI), USC. We have recently enrolled our first patients on this trial.
“Increasingly, health care is moving in a direction where instead of patients going to us for services, we are able to come to them, increasing access to care and potentially addressing existing health care disparities. If this study can show that at-home cancer immunotherapy is safe and feasible for non-small cell lung cancer, it will open the door for more home treatments for other types of cancers in the future.”
