Measuring symptom burden in patients with cancer during a pandemic: the MD Anderson symptom inventory for COVID-19 (MDASI-COVID).

BACKGROUND: Symptom expression in SARS-CoV-2 infection (COVID-19) may affect patients already symptomatic with cancer. Patient-reported outcomes (PROs) can describe symptom burden during the acute and postacute stages of COVID-19 and support risk stratification for levels of care. At the start of the COVID-19 pandemic, our purpose was to rapidly develop, launch through an electronic patient portal, and provide initial validation for a PRO measure of COVID-19 symptom burden in patients with cancer. METHODS: We conducted a CDC/WHO web-based scan for COVID-19 symptoms and a relevance review of symptoms by an expert panel of clinicians treating cancer patients with COVID-19 to create a provisional MD Anderson Symptom Inventory for COVID-19 (MDASI-COVID). English-speaking adults with cancer who tested positive for COVID-19 participated in the psychometric testing phase. Patients completed longitudinal assessments of the MDASI-COVID and the EuroQOL 5 Dimensions 5 Levels (EQ-5D-5L) utility index and visual analog scale, which were presented through an electronic health record patient portal. To test the validity of the MDASI-COVID to distinguish between known groups of patients, we hypothesized that patients hospitalized, including having a hospitalization extended, for COVID-19 versus those not hospitalized would experience higher symptom burden. Correlation of mean symptom severity and interference scores with relevant EQ-5D-5L scores tested concurrent validity. The reliability of the MDASI-COVID was evaluated by calculating Cronbach alpha coefficients and test-retest reliability was evaluated by calculating Pearson correlation coefficients between the initial assessment and a second assessment no more than 14 days later. RESULTS: The web-based scan found 31 COVID-19-related symptoms; rankings of a 14-clinician expert panel reduced this list to 11 COVID-specific items to be added to the core MDASI. Time from literature scan start in March 2020 to instrument launch in May 2020 was 2 months. Psychometric analysis established the MDASI-COVID's reliability, known-group validity, and concurrent validity. CONCLUSIONS: We were able to rapidly develop and electronically launch a PRO measure of COVID-19 symptom burden in patients with cancer. Additional research is needed to confirm the content domain and predictive validity of the MDASI-COVID and define the symptom burden trajectory of COVID-19.

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.

INTRODUCTION: Remote 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 ANALYSIS: This 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 DISSEMINATION: This 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 NUMBER: NCI202107464.

Feasibility of Mobile and Sensor Technology for Remote Monitoring in Cancer Care and Prevention

Objectives. Remote monitoring (RM) of health-related outcomes may optimize cancer care and prevention outside of clinic settings. CYCORE is a software-based system for collection and analyses of sensor and mobile data. We evaluated CYCORE's feasibility in studies assessing: (1) physical functioning in colorectal cancer (CRC) patients;(2) swallowing exercise adherence in head and neck cancer (HNC) patients during radiation therapy;and (3) tobacco use in cancer survivors post-tobacco treatment (TTP). Methods. Participants completed RM: for CRC, blood pressure, activity, GPS;for HNC, video of swallowing exercises;for TTP, expired carbon monoxide. Patient-reported outcomes were assessed daily. Results. For CRC, HNC and TTP, respectively, 50, 37, and 50 participants achieved 96%, 84%, 96% completion rates. Also, 91-100% rated ease and self-efficacy as highly favorable, 72-100% gave equivalent ratings for overall satisfaction, 72-93% had low/no data privacy concerns. Conclusion. RM was highly feasible and acceptable for patients across diverse use cases.