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.

The COVID-19 pandemic has had a dramatic impact on care delivery among health care institutions and providers in the United States. As a categorical cancer center, MD Anderson has prioritized care for our patients based on acuity of their disease. We continue to implement measures to protect patients and employees from acquiring the infection within our facilities, and to provide acute management of cancer patients with concomitant COVID-19 infections who are considered at high risk of death. The Division of Patient Experience, formerly established in October 2016, has played an integral role in the institution's pandemic response from its inception. The team actively supported programs and processes in anticipation of the pandemic's effect on our patients and employees. We will describe how the team continues to serve in the ever-dynamic environment as we approach the expected surge in

6510 Background: Most COVID-19 (C19) vaccine trials excluded patients with active cancer. Here, we report our real-world patient-reported and clinical outcomes of BNT162b2 mRNA C19 vaccine in patients with cancer. Methods: Our institutional Data-Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE) follows a longitudinal observational cohort of pts w cancer getting C19 vaccine. Pts complete a validated PRO tool, MD Anderson Symptom Inventory (MDASI, 13 core, 6 interference plus 17 items of symptoms from prior vaccine trials) pre-dose 1, then daily x 6d, then weekly, then on day of dose 2, then daily x 6d, then weekly x 3w. Demographics, cancer variables, prior immune checkpoint inhibitors (ICI), C19 status pre- & post-vaccine are aggregated via Syntropy platform: Palantir Foundry. Primary outcome is incidence of PRO symptoms bw dose 1 & 2 across AYA 15-39y, mid-age 40-64y & senior 65y+ cohorts. Secondary outcomes include PRO symptom incidence post-dose 2, post-vaccine change in cancer symptoms, post-vaccine symptom severity based on prior ICI, and confirmed C19 > 7 days post-dose 2. First planned 8-wk interim analysis is reported here. Results: 6388 pts w cancer (4973 w mets) received a BNT162b2 vaccine dose (4811 both doses, 1577 received one & await dose 2). Overall, median age 64y (range 16-95y); 382 AYAs, 2927 mid-age, 3079 seniors (65-70y n = 1158, 70-79y n = 1521, 80-89y n = 378, 90y+ n = 22). 4099 (64%) are White, 823 (13%) AA, 791 (12%) Hispanic, 441 (7%) Asians. Primary cancers: breast (1397), GU (821), heme (775), thoracic/HN (745), and CRC (385). Prior to dose 1, 1862 had no prior systemic tx while 4526 pts did including 3243 who had only non-IO tx (chemo, targeted tx), 1,283 had immunotherapy including 857 who had ICIs prior to dose 1. Patient-reported symptoms after C19 Vaccine: Of 6388 pts, 4714 (74% response rate, median age 67y, range 16-95y) completed 16485 PRO surveys. After 2 doses, seniors reported lower mean scores vs mid-age or AYAs on 22 of 36 symptoms including injection site pain, palpitations, itch, rash, malaise, fevers/chills, arthralgia, myalgia, headache, pain, fatigue, nausea, disturbed sleep, distress (p < 0.05). Pts w prior ICIs had higher severity of itch, rash (p < 0.05) from baseline after both dose 1 & 2 vs pts without systemic tx. Post dose 1, pts with prior ICI had higher increase in fatigue, malaise, itch, rash, myalgia, anorexia from their baseline vs pts without systemic tx (p < 0.05). C19 Outcomes: Of 6388 pts, 616 had a C19 test at any time post-dose 1: 23 (0.36%) tested positive of whom 20 (0.3%) were between dose 1 & 2; two (0.031%) were within 7 days post-dose 2, and one patient (0.016%) tested positive 16 days after dose 2, requiring admission. Conclusions: This real-world observational cohort demonstrates post-vaccine symptom burden and outcomes in patients with cancer. Second interim analysis is planned at 16 weeks.

PURPOSE Although electronic patient-reported outcomes (ePROs) are efficacious in symptom management, much is unknown about the utility of vital signs surveillance. We examined the feasibility of a remote patient monitoring platform that integrates ePROs and biometrics into the ambulatory management of symptom burden. METHODS Using a decentralized workflow, patients with gastrointestinal or thoracic cancer were approached for a 1-month study. Patients reported symptom burden via ePROs and biometrics (blood pressure, oxygen saturation, pulse, weight, and temperature) using bluetooth-enabled devices daily. Alerts on the basis of prespecified thresholds were managed via nurse-led triage. Adherence was defined as the completion of > 70% of daily symptom and biometric reporting requirements. Pilot acceptability, appropriateness, and feasibility were measured using validated instruments. Net promoter score, system usability scale, and emergency department (ED) admission rates were collected. RESULTS Over 8 months, 36 patients were enrolled and 25 (60% gastrointestinal) completed the study. Participants had a mean age of 58.0 years, mean Eastern Cooperative Oncology Group score of 0.88, were 52% female, and predominantly had stage IV or recurrent disease (72%). Program adherence was 73% and associated with high acceptability (4.63), feasibility (4.56), and appropriateness (4.46). System usability scale and net promoter score scores were 88 and 55, respectively. Seventy percent of alerts were generated by biometrics, 28% for symptoms, and 2% were patient-initiated communication. Finally, the ED visitation rate over the pilot period was 8%. CONCLUSION Our remote patient monitoring pilot program was highly acceptable, feasible, and appropriate. It had high rates of patient adherence and satisfaction and was associated with low ED visitation rates.

Background: Readmission to hospitals for heart failure is one of the greatest economic burdens on Medicare, and has become a major focus of healthcare reform. In an attempt to stem the overwhelming number of readmissions and improve heart failure outcomes, hospitals have employed multiple interventions. Nurse-led heart failure management programs have been an effective strategy in reducing hospital readmissions for heart failure. Purpose:We conducted an integrative review of the literature that assessed the value of interventions to reduce heart failure readmission rates. We focused on the important role of nursing care in successfully implementing many of these interventions.Methods: An integrative review of the literature was performed. A computerized search of PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Cochrane Library (reviews and clinical trials) was performed to locate articles published from 2004 to 2014. Key words used included "heart failure nursing", "heart failure readmissions", "heart failure programs" and "interventions for heart failure readmission". Preference was placed on articles published in the last 10 years. Articles referenced by national heart failure guideline documents and expert consensus statements were given a high priority. Eighty-eight articles were screened initially by two reviewers; these were then screened to leave 40 relevant articles. Conclusions:Several specific interventions have a proven favorable effect in reducing heart failure readmissions. These include optimal medical management, patient education and self-care instruction, and ensuring adequate post-discharge follow-up. Despite this knowledge there remains a wide variation of readmission rates across the United States. This may be partly due to the variability in the adequate implementation of interventions and/or the absence of a required number of interventions in different centers. Each single intervention in itself has only a very small beneficial effect. The implementation of several interventions is essential to produce a meaningful reduction in heart failure readmissions. The ability to successfully employ numerous interventions together may explain the promising results of structured nurse-led heart failure programs.