University of Minnesota Health and Fairview Health Services Propel Cancer Care Forward with Digital Medicine

By Thomas Crocker
Tuesday, June 18, 2019

University of Minnesota Health and Fairview Health Services specialists are pioneering the use of digital medicine in oncology, giving patients more control over the common oral chemotherapy process and their medical caregivers deeper insight into patients’ health and compliance with treatment — all for the sake of improving outcomes.

In a partnership with California-based Proteus Digital Health, University of Minnesota Health providers and Fairview Health Services specialty pharmacists are using a new type of pharmaceutical called digital medicine to treat select patients with stage 3 or 4 colorectal cancer. The Proteus Discover technology consists of a small, ingestible, FDA-approved sensor that pharmacists encapsulate with a common oral chemotherapeutic agent, a patch patients wear that records data collected by the sensor and a secure, downloadable application that syncs with the patch to allow physicians to view patient data on a computer or mobile device. The pilot project launched in fall 2018 and is ongoing. It is the first use of digital medicine to treat patients with cancer.

“Proteus Discover gives physicians and other providers a much better window into what’s going on in our patients’ lives as we take care of them,” says Edward Greeno, MD, Executive Medical Director of the Cancer Care Service Line and Medical Director of the Masonic Cancer Clinic with University of Minnesota Health and Professor of Medicine in the University’s Division of Hematology, Oncology and Transplantation. “It’s part of the transition of health care away from the hospital and clinic to the home.”

Oral Chemotherapy: Boon and Burden

Oral chemotherapy presents a quandary for patients and clinicians. It increases the convenience of care for patients by allowing them to take medications at home on their schedule without having to make frequent daily visits to an infusion clinic, but it also places the onus on patients to monitor their own adherence to treatment and to recognize when their responses to medication merit a check-in with physicians. With treatment protocols historically having been built around infusion, oral chemotherapy regimens disrupt some of the standard treatment safeguards.

“We’ve built all sorts of safety mechanisms around IV chemotherapy, and we’ve built some of them into oral chemotherapy as well, but they’re not quite as convenient,” Dr. Greeno says. “With oral chemotherapy, being able to see what’s actually happening with a patient — that she is taking the correct medication at a given time and is in a suitable health state for the treatment, as we would be able to assess with infusion — gets lost because the patient is taking the drug at home. Instead of an infusion nurse determining whether the patient is well enough to take a medication and that it’s the correct drug and dosage, the patient has to do it, which she isn’t trained to do.”

The nurses and Fairview pharmacists who monitor patients taking oral chemotherapy via regular phone calls depend on patients to accurately report information about treatment compliance, side effects and pill stock, which can be problematic.

“We’re reliant on subjective data from patients receiving oral chemotherapy when we’re used to objective data from on-site infusion,” says Paul Morales, PharmD, BCOP, Fairview Health Services Infusion Pharmacy Manager at the University of Minnesota Health Clinics and Surgery Center. “Reaching patients at home can be difficult. I know exactly when a patient who is receiving IV chemotherapy will be in the infusion chair for treatment, but with oral chemotherapy, our nurses and pharmacists may spend a lot of time just trying to reach a patient to check in.”

Digital Data Collection

To test whether the digital medicine Proteus Discover can help resolve these issues, providers with University of Minnesota Health and Fairview joined Proteus Digital Health to design a pilot project for capecitabine, an oral chemotherapeutic agent oncologists frequently prescribe to treat colorectal cancer.

“We chose to focus on colorectal cancer because it’s a common cancer, and almost all patients will end up getting capecitabine, which has been around for some time and with which we have substantial experience,” Dr. Greeno says. “With conventional oral chemotherapy, patients usually take multiple capecitabine tablets twice a day for two weeks and then take a week off before starting the next cycle. In the adjuvant setting, treatment with the drug may last six months. For advanced disease, patients receive treatment for as long as it remains effective.”

When a patient enrolls in the pilot project, she downloads the secure Proteus Discover app. Access to the app is restricted to the patient, her designated caregivers and medical team, including a medical oncologist, monitoring pharmacist and nurse care coordinator. The patient inputs her treatment schedule with help from her medical team. She receives the prescribed amount of medication as capsules, each of which contains a capecitabine pill and a grain-of-sand-size silicon chip embedded in a sugar pill. When the patient ingests a capsule, it and the pills inside dissolve, and the chip goes to work.

“The chip emits a heartbeat-like signal that is detected by a patch, which the patient wears on her abdomen,” Morales says. “The patch records the time the medicine was taken and records biometric data, such as activity level, step count, resting heart rate and sleep information.”

When the patient logs into the app, she can track her adherence to her dosing schedule and see when the cycle ends, as well as report symptoms to her care team. Medical providers with access to the portal can see how many pills the patient takes and when, and they can check to be sure the patient is taking her medication within the dosing window — one hour before or after the dosing times the patient sets for herself, typically once in the morning and once in the evening. If the patient misses a dose, the app sends her a digital reminder or asks her to enter a reason for noncompliance.

“Proteus Discover increases transparency for the care team,” Morales says. “At any time, physicians, pharmacists and nurse care coordinators can see individuals’ information immediately, whereas in the past, they were reliant on outreach phone calls, typically made by the pharmacists, to obtain the most up-to-date information.”

“Patients enjoy being able to see their dosing and track the progress of their treatment cycles. They lose a lot of control when they’re diagnosed with cancer, but digital medicine helps them reassert some power over and take ownership of their health care.” 
— Paul Morales, PharmD, BCOP, Fairview Health Services Infusion Pharmacy Manager at the University of Minnesota Health Clinics and Surgery Center, speaking about Proteus Discover, a digital medicine from Proteus Digital Health in use with certain colorectal cancer patients receiving care through University of Minnesota Health and Fairview Health Services

Peace of Mind for Patients

For patients, Proteus Discover adds a layer of oversight to a complex at-home treatment process that otherwise has the potential to leave them feeling overwhelmed, even when a monitoring protocol, such as phone check-ins, is in place.

“The patients who’ve used Proteus Discover have loved it, and part of the reason is feeling safe and in control,” Dr. Greeno says. “With conventional oral chemotherapy, patients have to look in the mirror, so to speak, and give themselves the drug, which can be intimidating. Proteus Discover turns that mirror into a window for their care team to monitor them. Having an extra layer of oversight while remaining in control is empowering for patients.”

The ability for patients to keep track of the progress of their medication regimens has been one of the digital medicine’s most valuable benefits, especially for patients who are parents and busy professionals with hectic lives and numerous demands on their time. Dr. Greeno says a single mother who entered the pilot project no longer had to resort to emptying her pills onto a table and counting them late at night because she could not remember whether she took her evening dose — all she had to do was check the portal.

The data collected by Proteus Discover, and its symptom-reporting functionality, have allowed the providers to identify side-effect trends and intervene early.

“If, for example, a patient is experiencing nausea on day 10 of every treatment cycle, we can suggest something to take at that time to combat it,” Morales says. “There is a lot of potential for us to find trends and make recommendations for better patient care. Ultimately, the goal is to keep patients on the right dose for the right amount of time because we know patients who stay on schedule with treatment experience better outcomes.”

Early intervention helped a patient stay on track with her regimen when a side effect of capecitabine threatened to derail her progress. After a few cycles of treatment, the patient’s palms became tender, which made opening her pill bottles difficult. One day, when no one was around to open the bottle for her, she skipped her dose, and the app prompted her to provide an explanation.

“Without Proteus Discover, I might not have known this patient was unable to open her pill bottles until I saw her in clinic again,” Dr. Greeno says. “That was an easy problem to fix.”

Dr. Greeno believes that Proteus Discover may also potentially make cancer care more cost-effective.

“From an economic standpoint, it’s worthwhile to not give patients more pills than they need and to know when they’re taking them,” he says. “Some oral chemotherapy agents cost $100 per pill. If we have accurate pill counts and start/stop dates and can avoid dispensing just one or two more pills than is necessary, we can save the healthcare system a lot of money.”

A Digital Future

Digital medicine in cancer care seems poised to expand, based on the early results of and patients’ experiences with Proteus Discover. University of Minnesota Health and Fairview team members together with Proteus Digital Health are considering other oral chemotherapy drugs to pair with the technology, according to Morales. For Dr. Greeno, a future in which all oral chemotherapy regimens include a digital tracking component is not far-fetched.

“I think embedding digital technology in many, if not all, of our oral cancer drugs would be valuable,” he says. “In addition to knowing when patients take their pills, it’s exciting to think about seeing what may be going on with patients from afar, such as how they’re taking medications for pain and nausea. That would produce a picture of patients’ health that’s so much more vivid than what I can obtain in a 30-minute office visit every couple of months.”

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Next Steps: Digital Medicine Gets Supportive

Many patients who receive oral chemotherapy drugs also go home with medications they can take on an as-needed basis to combat side effects. In the future, those supportive care medications may contain digital sensors.

Providers and specialty pharmacists with University of Minnesota Health and Fairview Health Services are working with Proteus Digital Health to test supportive care medications equipped with the same digital sensor used in Proteus Discover, a digital medicine that, in a pilot project, is currently being co-encapsulated with the oral chemotherapy agent capecitabine. It is hoped that digital sensor-equipped medications can assist medical teams in tracking treatment responses. If a patient starts taking an antidiarrheal medication, for example, his medical team would be able to note that in the data relayed to the system’s secure portal and intervene quickly to ensure the side effect does not trigger complications.

“Diarrhea is a side effect of capecitabine that can amplify its toxicity,” says Edward Greeno, MD, Executive Medical Director of the Cancer Care Service Line and Medical Director of the Masonic Cancer Clinic with University of Minnesota Health and Professor of Medicine in the University’s Division of Hematology, Oncology and Transplantation. “When we include the Proteus Discover sensor with patients’ antidiarrheal drugs and other supportive care medications, I’ll be able to see in real time when patients are beginning to get sick, reach out and ask them to come into clinic for IV fluids or whatever intervention is necessary so they don’t end up in an emergency department.”