Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer.

BACKGROUND: Patients with cancer often endure substantial symptoms and treatment toxicities leading to high healthcare utilization, including hospitalizations and emergency department visits, throughout the continuum of their illness. Innovative oncology care models are needed to improve patient outcomes and reduce their healthcare utilization. Using a novel hospital at home care platform, we developed a Supportive Oncology Care at Home intervention to address the needs of patients with cancer. METHODS: We are conducting three trials to delineate the role of Supportive Oncology Care at Home for patients with cancer. The Supportive Oncology Care at Home intervention includes: (1) a hospital at home care model for symptom assessment and management; (2) remote monitoring of daily patient-reported symptoms, vital signs, and body weight; and (3) structured communication with the oncology team. Our first study is a randomized controlled trial to test the efficacy of Supportive Oncology Care at Home versus standard oncology care for improving healthcare utilization, cancer treatment interruptions, and patient-reported outcomes in patients with cancer receiving definitive treatment of their cancer. Participants include adult patients with gastrointestinal and head and neck cancer, as well as lymphoma, receiving definitive treatment (e.g., treatment with curative intent). The second study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention for hospitalized patients with advanced cancer. Eligible participants include adult patients with incurable cancer who are admitted with an unplanned hospitalization. The third study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention to enhance the end-of-life care for patients with advanced hematologic malignancies. Eligible participants include adult patients with relapsed or refractory hematologic malignancy receiving palliative therapy or supportive care alone. DISCUSSION: These studies are approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and are being conducted in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. This work has the potential to transform the paradigm of care for patients with cancer by providing them with the necessary support at home to improve their health outcomes and care delivery. TRIAL REGISTRATIONS: NCT04544046, NCT04637035, NCT04690205.

Health-Related Quality of Life and Depression Symptoms in a Cross Section of Patients with Advanced Lung Cancer before and during the COVID-19 Pandemic.

Background: Adults with advanced lung cancer experience reduced health-related quality of life (HRQOL) and psychological symptoms at diagnosis. Objective: This study aimed to evaluate whether the COVID-19 pandemic worsened HRQOL among patients recently diagnosed with cancer. Design: We analyzed baseline data from two randomized controlled trials of early palliative care to compare HRQOL and depression symptoms among those enrolled during the pandemic (January 2020 to January 2021) versus prepandemic (March 2018 to January 2019). Setting/Subjects: This cohort included patients recently diagnosed with advanced lung cancer in two multisite studies. Measurements: We used analysis of covariance to calculate adjusted mean differences between groups with the timeframe as an independent variable and HRQOL (using the Functional Assessment of Cancer Therapy-General) and depression symptoms (using the Patient Health Questionnaire-9) as dependent variables, adjusting for age, gender, relationship status, performance status, symptoms, and time since diagnosis. We tested for an interaction between the COVID-19 timeframe and relationship status. Results: Neither HRQOL (adjusted mean difference -1.78; p = 0.137) nor depression symptoms (0.06; p = 0.889) differed between patients enrolled pre-COVID-19 (n = 665) relative to those enrolled during COVID-19 (n = 191) in adjusted analyses. Relationship status moderated the effect of the COVID-19 timeframe on HRQOL; unmarried patients experienced worse HRQOL during COVID-19 (adjusted mean difference: -5.25; p = 0.011). Conclusions: The COVID-19 pandemic did not further reduce HRQOL or increase depression symptoms among patients recently diagnosed with lung cancer, but did worsen HRQOL for unmarried patients in moderation analysis. Psychosocial evaluation and supportive care are important for all patients, particularly those with limited social support. Clinical trial registration numbers: NCT03337399 and NCT03375489.

Study protocol for a randomised trial evaluating the non-inferiority of stepped palliative care versus early integrated palliative care for patients with advanced lung cancer.

INTRODUCTION: Integrating palliative care (PC) early in the illness course for patients with serious cancers improves their outcomes and is recommended by national organisations such as the American Society of Clinical Oncology. However, monthly visits with PC clinicians from the time of diagnosis can be challenging to implement due to the lack of specialty-trained PC clinicians and resources. Therefore, we developed a stepped care model to triage PC service based on patients' needs. METHODS AND ANALYSIS: We are conducting a non-blinded, randomised trial to evaluate the non-inferiority of a stepped PC model compared with an early integrated PC model for improving patients' quality of life (QOL) at 24 weeks (primary outcome). Patients assigned to early integrated PC meet with PC every 4 weeks throughout their illness. Patients assigned to stepped PC have PC visits only at clinically significant points in their illness (eg, cancer progression) unless their QOL decreases, at which time they are 'stepped up' and meet with PC every 4 weeks throughout the remainder of their illness. Secondary aims include assessing whether stepped PC is non-inferior to early integrated PC regarding patient-clinician communication about end of life care and length of stay on hospice as well as comparing resource utilisation. Patients are recruited from the Massachusetts General Hospital Cancer Center, Boston, Massachusetts; Duke Cancer Center, Durham, North Carolina and University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania. The target sample size is 510 patients. ETHICS AND DISSEMINATION: The study is funded by the National Cancer Institute, approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and will be reported in accordance with the Consolidated Standards of Reporting Trials statement. We will disseminate results through professional society meetings, peer-reviewed publications and presentations to patient organisations. TRIAL REGISTRATION NUMBER: NCT03337399.

Supportive Oncology Care at Home Intervention for Patients With Pancreatic Cancer.

PURPOSE: We sought to determine the feasibility of delivering a Supportive Oncology Care at Home intervention among patients with pancreatic cancer. METHODS: We prospectively enrolled patients with pancreatic cancer from a parent trial of neoadjuvant fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFIRINOX). The intervention entailed (1) remote monitoring of patient-reported symptoms, vital signs, and body weight; (2) a hospital-at-home care model; and (3) structured communication with the oncology team. We defined the intervention as feasible if ≥ 60% of patients enrolled in the study and ≥ 60% completed the daily assessments within the first 2-weeks of enrollment. We determined rates of treatment delays, urgent clinic visits, emergency department visits, and hospitalizations among those who did (n = 20) and did not (n = 24) receive Supportive Oncology Care at Home from the parent trial. RESULTS: From January 2019 to September 2020, we enrolled 80.8% (21/26) of potentially eligible patients. One patient became ineligible following consent because of moving out of state, resulting in 20 participants (median age = 67 years). In the first 2 weeks of enrollment, 65.0% of participants completed all daily assessments. Overall, patients reported 96.1% of daily symptoms, 96.1% of daily vital signs, and 92.5% of weekly body weights. Patients receiving the intervention had lower rates of treatment delays (55.0% v 75.0%), urgent clinic visits (10.0% v 25.0%), and emergency department visits/hospitalizations (45.0% v 62.5%) compared with those not receiving the intervention from the same parent trial. CONCLUSION: Findings demonstrate the feasibility and acceptability of a Supportive Oncology Care at Home intervention. Future work will investigate the efficacy of this intervention for decreasing health care use and improving patient outcomes.