Active surveillance of chemotherapy-related symptom burden in ambulatory cancer patients via the implementation of electronic patient-reported outcomes and sensor-enabled vital signs capture: protocol for a decentralised feasibility pilot study

Abstract

IntroductionRemote patient monitoring (RPM) has emerged as a potential avenue for optimising the management of symptoms in patients undergoing chemotherapy. However, RPM is a complex, multilevel intervention with technology, workflow, contextual and patient experience components. The purpose of this pilot study is to determine the feasibility of RPM protocol implementation with respect to decentralised recruitment, patient retention, adherence to reporting recommendations, RPM platform usability and patient experience in ambulatory cancer patients at high risk for chemotherapy-related symptoms.Methods and analysisThis protocol describes a single-arm decentralised feasibility pilot study of technology-enhanced outpatient symptom management system in patients with gastrointestinal and thoracic cancer receiving chemotherapy and cancer care at a single site (MD Anderson Cancer Center, Houston Texas). An anticipated total of 25 patients will be recruited prior to the initiation of chemotherapy and provided with a set of validated questionnaires at enrollment and after our 1-month feasibility pilot trial period. Our intervention entails the self-reporting of symptoms and vital signs via a HIPAA-compliant, secure tablet interface that also enables (1) the provision of self-care materials to patients, (2) generation of threshold alerts to a dedicated call-centre and (3) videoconferencing. Vital sign information (heart rate, blood pressure, pulse, oxygen saturation, weight and temperature) will be captured via Bluetooth-enabled biometric monitoring devices which are integrated with the tablet interface. Protocolised triage and management of symptoms will occur in response to the alerts. Feasibility and acceptability metrics will characterise our recruitment process, protocol adherence, patient retention and usability of the RPM platform. We will also document the perceived effectiveness of our intervention by patients.Ethics and disseminationThis study has been granted approval by the institutional review board of MD Anderson Cancer Center. We anticipate dissemination of our pilot and subsequent effectiveness trial results via presentations at national conferences and peer-reviewed publications in the relevant medical journals. Our results will also be made available to cancer survivors, their caregivers and hospital administration.Trial registration numberNCI202107464.

Integration of Remote Symptom and Biometric Monitoring Into the Care of Adult Patients With Cancer Receiving Chemotherapy—A Decentralized Feasibility Pilot Study

“…Ad hoc feedback from pilot participants to the call center staff revealed a perception of our RPM intervention as a crucial element of their cancer management and not research, bolstering our strategy to leverage the lived experience of PFAC members during program conceptualization. 12 This approach also catalyzed the iteration of several components of our RPM program (eg, patient education materials and alert parameters) to be more patient-centered and meaningful. 12 Decentralized trial is a COVID-related adaptation to the research enterprise that has the potential to increase patient accrual, reduce costs, and improve the speed of study completion.…”

“…12 This approach also catalyzed the iteration of several components of our RPM program (eg, patient education materials and alert parameters) to be more patient-centered and meaningful. 12 Decentralized trial is a COVID-related adaptation to the research enterprise that has the potential to increase patient accrual, reduce costs, and improve the speed of study completion. 11,13 To the best of our knowledge, the present pilot is one of the first descriptions of decentralized study conduct in oncology and was borne of the need to recruit patients during the pandemic while preserving personal protective equipment for health care workers.…”

“…This is because operationalizing RPM is a complex undertaking with workforce, cultural, technology, patient experience, and financial implications. 6,12 Beyond evaluating the incremental effectiveness of biometric capture, relative to PROs alone, which will be evaluated in a future RCT, we will also attempt to delineate the contextual drivers, facilitators, and barriers to deploying RPM. Future treatment paradigms and clinical settings that might benefit from this paradigm (ie, RPM of PROs and biometrics), if shown to be effective, include rural cancer populations, palliative care, surgical prehabilitation programs, and hematologic malignancies.…”

“…20 Email communication was initiated with the treating oncologist to confirm appropriateness on the basis of published risk factors for acute care utilization. 12,17 Our screening workflow was eventually automated during the last month of the pilot using a commercially available natural language processing platform (Deep6 AI, Pasadena, CA). Deep6 applies artificial intelligence techniques to clinical data to accelerate trial recruitment by identifying and matching eligible patients.…”

“…14,15 The utility of integrating biometric data (ie, vital signs) into the ambulatory management of treatment-or disease-related symptom burden remains an open question. 12,16 Therefore, we investigated the feasibility and implementation outcomes regarding the use of an RPM platform for monitoring symptom burden and biometrics in high-risk patients receiving chemotherapy. We also evaluated the effectiveness of a virtual or decentralized workflow for patient recruitment, education, symptom monitoring, and study completion.…”