Tracking side effects with wearables
Anti-nausea drugs and other supportive cancer medications have been game-changers for patients going through chemotherapy, helping them complete treatment without health complications like infection, excessive vomiting or other incapacitating side effects.
Still, half of the nearly 370,000 cancer patients in the U.S. who receive chemotherapy have to go to the emergency room or stay in the hospital unexpectedly each year due to poorly controlled symptoms or treatment side effects.
How do we fix that? Researchers with Fred Hutch’s HICOR group have initiated a study that will use both a smartphone app and a wearable biosensor smartwatch to help identify patients who may be at a higher risk for an ER or hospital visit. HICOR co-directors Drs. Scott Ramsey and Veena Shankaran are principal investigators.
Details of the forthcoming trial were presented as a poster at ASCO’s 2022 meeting and simultaneously published in the Journal of Clinical Oncology. The new study enrolls patients ages 18 to 80 who have a biopsied solid tumor (in other words, no lymphomas or leukemias) and are scheduled to receive their first IV or oral cancer therapy as an initial or a new line of treatment.
Open to both early-stage and metastatic patients, the trial asks participants to wear their biosensor daily and complete surveys (surveys will be in English for this first trial) that capture patient-reported outcomes, such as fatigue, nausea/vomiting, fever, diarrhea, etc. Patients who receive anti-hormone therapy and/or radiation without chemotherapy are not eligible for the trial.
The study will have two phases. The vanguard phase will enroll 30 patients for a two-week trial run; a second, operational phase, enrolling 70 patients, will launch later.
“The vanguard sample size allows for the recruitment of around 10 patients at each of the three participating oncology community clinics, which is standard for initial device and software testing and development,” said HICOR’s Karma Kreizenbeck, lead author on the study.
Kate Watabayashi, senior project manager for HICOR, said the trial should be relatively easy for participants.
“The smartwatch passively collects things like vital signs, and the app has a symptom survey that patients are asked to complete daily during the study period,” she said. “Phase one is where we are assessing feasibility and usability of the biosensor and the app.”
The vanguard phase will evaluate patient recruitment, completeness of data capture, app usability and user satisfaction with the biosensor, among other things. The operational phase aims to confirm the vanguard findings in a larger sample of patients and validate data such as patient-reported information regarding hospital visits.
“Data collected from the vanguard will inform modifications to the app for the operational phase,” Kreizenbeck said, adding the operational phase will include enough patients that the researchers will be able to test it out in both low-volume and high-volume treatment centers as well as those in rural and urban settings.
“The hope,” Watabayashi explained, “is that we can eventually develop a wearable sensor and app combination that would help patients monitor their symptoms during chemotherapy and communicate with their care teams to avoid unnecessary emergency department or in-patient hospital visits during treatment.”
Funding for the study of eligibility criteria was provided by the Fred Hutch Public Health Sciences Division. Funding for the study of the effect of Medicaid’s expansion on cancer clinical trials was provided by the NIH/NCI, an American Cancer Society Research Scholar grant and The Hope Foundation for Cancer Research. Funding for HICOR’s real-world practice patterns study was provided by the Conquer Cancer Foundation of ASCO and Pfizer, and funding for HICOR’s wearables study was provided by F. Hoffmann-La Roche Ltd./Genentech, Inc.