Portable, patient-administered, sensor-enhanced scalp cooling cap and smartphone APP to reduce provider burden, improve patient access, and improve patient outcomes for chemotherapy-induced alopecia

Cooler Heads Care, Inc. was awarded a $632,981.28 Project Grant from the National Cancer Institute's Cancer Cause and Prevention Research program (CFDA 93.393) to develop a portable, patient-administered scalp cooling device and smartphone application. The goal is to reduce barriers to scalp cooling access for chemotherapy patients experiencing hair loss. Cooler Heads will develop training materials and conduct usability testing to demonstrate patients can self-administer the scalp cooling device, which is the size of a carry-on suitcase and can be rented for $800. A smartphone app will provide reminders, instructions, and track infusion times. If successful, the portable device has potential to transform scalp cooling delivery by allowing self-administration and freeing up infusion chair space. Completion is scheduled for January 2022.

Abstract

Drawing on the experiences of patients and healthcare providers, cooler heads care has engineered a low-cost, portable, sensor-enhanced scalp cooling device and smartphone APP patients can use to prevent the disfiguring effects of chemotherapy-induced alopecia (CIA). Despite the efficacy of scalp cooling, most infusion centers do not offer scalp cooling because the devices are bulky, expensive, and burdensome. Commercialization of a portable, patient-administered device has the potential to eliminate provider burden; reduce costs; and improve patient access, well-being, and quality of life. Each year, > 650,000 americans undergo chemotherapy, and > 65% experience CIA. Patients rank CIA as one of the most concerning side effects of chemotherapy, and IT is a significant contributor to poor body image, decreased psychological well-being, and higher rates of depression-all of which contribute to higher costs and poorer outcomes. Multiple trials have shown that cooling the scalp to 3O to 5O c during and after chemotherapy is the most effective means for preventing CIA. Unfortunately, only about 20% of infusion centers offer scalp cooling because 1) the center must lease / maintain the device; 2) staff must administer IT; 3) only two patients can use IT at a time; 4) IT extends use of the infusion chair by up to 3.5 hours; and 5) inconsistent insurance coverage presents challenges for charging. Patients can rent GEL cap systems, but dry ICE and a person to administer the treatment can cost > $5,000. To overcome these challenges, cooler heads designed a patient-administered portable device the size of a carry-on suitcase that patients can rent for $800 for the duration of chemotherapy. The device includes an electric chiller connected to a comfortable multi-leaf cap that expands to fit the patient's head, and sensors in the cap monitor scalp temperature and modulate coolant flow. An onboard battery and car charger allow mobile use after infusions, freeing up chairs for other patients. A smartphone APP provides patient reminders and instructional videos, tracks infusion times, and provides tips on hair care. The FDA has determined cooler heads needs to 1) develop training materials and conduct usability testing to demonstrate patients can use the device as intended (phase i sbir) and 2) conduct a trial to demonstrate the patient-administered device is efficacious (future phase II). Thus, cooler heads proposes the following: aim. Demonstrate the feasibility of delivering scalp cooling with a patient-administered device. Sub-aim 1. Develop and refine training materials to demonstrate the use of the device. Sub-aim 2. In a study with 20 healthy adults from diverse backgrounds, assess the usability of the device and feasibility of self-administration in a simulated chemotherapy infusion scenario. Milestones: 1) = 80% of participants can complete critical tasks without outside assistance, 2) = 90% can complete them with phone support, 3) AVG. Setup time = 10 min. Impact: this device has the potential to transform the delivery of scalp cooling, meeting NCI's cancer moonshot priority for reducing major side effects of cancer therapy by reducing barriers that prevent most patients from accessing this effective technology.