ABSTRACT
Background: Given the current physical isolation and distancing measures in place as a result of the COVID- 19 pandemic, and the health risks associated with leaving one's home, cancer patients face new and unprecedented challenges in connecting with their communities and conducting activities of daily living. They are also experiencing changes in their treatment and medical follow-up plans. Consequently, they are at even greater risk of experiencing loneliness, anxiety, depression, and reduced quality of life compared to the general population. There is emerging evidence for the use of mobile health applications to improve social connections, engage patients in their own health, and provide psychosocial support among cancer survivors. Thus, we are conducting the COMPANION study to examine the use of a mobile health application, Elly, to reduce levels of anxiety, stress, and feelings of social isolation and loneliness as a result of isolation during the COVID-19 pandemic among cancer patients and survivors (NCT04604158). Methods: This is a prospective, interventional study of patients who self-identify as currently receiving cancer-targeted treatment. All study recruitment and consent procedures, assessments, and follow-up are completed remotely using REDCap. Participants are given access to the Elly phone application developed by Elly Health Inc. and followed for 6 months. Elly is a multi-platform mobile solution that enables cancer patients to receive support and assistance in the management of their illness. Elly delivers audio content through a mobile app to comfort, inspire and motivate its users including tools to manage their diagnosis and symptoms including interactive sessions on motivation, unspoken (taboo topics), exercise, mindfulness, sleep, nutrition, self-care, and symptom as well as COVID-19 specific topics. Results: The COMPANION trial is currently open to accrual. Approximately 100 patients will be enrolled between November 2020 and December 2021. Trial design and protocol development, regulatory activities including submission to the local ethics review board, and communication was completed remotely and included an interdisciplinary team of clinical trialists, behavioral scientists, oncologists, and psychiatrists. This study provides an example of how clinical trials may be developed and managed in a decentralized manner and under budget and time constraints. Surveys will be administered through REDCap at baseline and monthly thereafter to assess the patient's social status, medical history (including history of COVID-19), and National Institutes of Health PROMIS anxiety, depression, perceived stress, pain, loneliness, social support, and global health scales. Participants may opt to wear and link activity trackers in order to obtain objective measures of daily activity. Patients will also have the option to consent to the optional qualitative interview sub-study. Conclusion: Using COMPANION as a case example, we demonstrate the feasibility of designing and conducting a trial to monitor patient outcomes and deliver a mobile health intervention in a remote setting. Findings from this work will provide fundamental knowledge of the additional impact COVID-19 has had on cancer patients' anxiety, depression, and stress levels. This study will also improve our understanding of the short- and long-term effects of COVID-19 and how it's trajectory over the course of the next 6 months and beyond will impact these outcomes.
Subject(s)
COVID-19 , Neoplasms , COVID-19 Vaccines , Humans , Neoplasms/drug therapy , SARS-CoV-2 , Vaccination/adverse effectsABSTRACT
Background: Cancer patients are at increased risk of severe COVID-19 illness because of their systemic immunosuppressive state. The potential effects of cancer and/or anticancer treatments on COVID-19 vaccine response, adverse events and progression are unknown. Moreover, the impacts of financial, familial and societal stressors during the pandemic on health-related quality of life are unclear. To address these concerns, we report data from the ongoing U.S. NCI-funded SeroNet COVID-19 Risk Associations and Longitudinal Evaluation Study (CORALE) at a large health care system in Los Angeles. Methods: Cancer patients are invited to complete questionnaires, donate blood specimens and engage in long-term follow-up with repeat questionnaires and biosampling. Patient-reported outcomes are assessed at baseline, post-vaccination, 6, 12 and 24 months. Clinical information on cancer type, stage, treatment, dates, medications and outcomes (adverse events, SARS-CoV-2 infection, COVID-19 vaccination and cancer-related outcomes) are extracted from electronic medical records. Results: From December 2019-May 2020, we enrolled 317 patients with malignancies or hematologic disorders (70.0% response rate). The median age was 63 (interquartile range (IQR)=54-73) years, 47% were women, 30% self-identified as non-White minorities and 18% were unable to work due to health status. 3% were known to been infected with SARS-CoV-2. An overall COVID-19 vaccine acceptance rate of 80% was reported. Among unvaccinated patients, women expressed more hesitancy than men (p=0.045). Concerns about adverse events (56%), rushed vaccine development (44%), and insufficient knowledge (44%) were reported. Self-reported symptoms after the first dose included injection site pain (21%) and fatigue (11%). We observed low levels of depression and high emotional support. Enrollment is ongoing. Conclusions: Individuals with cancer are a complex and extremely diverse population with a multitude of considerations for both immediate clinical care and long-term survivorship. Updated results including findings on antibody response to vaccination across cancer types/treatment protocols will be presented. Legal entity responsible for the study: Cedars-Sinai Medical Center. Funding: U.S. National Cancer Institute. Disclosure: All authors have declared no conflicts of interest.