Early Integrated Telehealth versus In-Person Palliative Care for Patients with Advanced Lung Cancer: A Study Protocol

Abstract

Introduction: Early palliative care (PC) integrated with oncology care improves quality of life (QOL), depression symptoms, illness understanding, and end-of-life (EOL) care for patients with advanced lung cancer. The aims of this trial are to compare the effect of delivering early integrated PC through telehealth versus in-person on patient and caregiver outcomes. We hypothesize that both modalities for delivering early PC would be equivalent for improving patient QOL, communication about EOL care preferences with their oncologist, and length of stay in hospice. Methods: For this comparative effectiveness trial, we will enroll and randomize 1250 adult patients with advanced nonsmall cell lung cancer (NSCLC), who are not being treated with curative intent, to receive either early integrated telehealth or in-person PC at 20 cancer centers throughout the United States. Patients may also invite a family caregiver to participate in the study. Patients and their caregivers in both study groups meet at least every four weeks with a PC clinician from within 12 weeks of patient diagnosis of advanced NSCLC until death. Participants complete measures of QOL, mood, and quality of communication with oncologists at baseline before randomization and at 12, 24, 36, and 48 weeks. Information on health care utilization, including length of stay in hospice, will be collected from patients' health records. To test equivalence in outcomes between study groups, we will compute analysis of covariance and mixed linear models, controlling for baseline scores and study site. Study Implementation and Stakeholder Engagement: To ensure that this comparative effectiveness trial and findings are as patient centered and meaningful as possible, we have incorporated a robust patient and stakeholder engagement plan. Our stakeholder partners include (1) patients/families, (2) PC clinicians, (3) telehealth experts and clinician users, (4) representatives from health care systems and medical insurance providers, and (5) health care policy makers and advocates. These stakeholders will inform and provide feedback about every phase of study implementation.

Virtual Care in Patients with Cancer: A Systematic Review

“…Five ongoing studies were found in the literature search and details are summarized in the Supplementary Material (Table S2 ) [ 39 , 40 , 41 , 42 , 43 ].…”

Models of Integration of Specialized Palliative Care with Oncology

“…Despite these limitations, this model of care has been received positively by both patients and palliative care providers [ 70 ]. Research on several telehealth palliative care interventions is ongoing [ 71 , 72 ], and the next decade will undoubtedly bring a wealth of evidence in this regard.…”

Video and In-Person Palliative Care Delivery Challenges before and during the COVID-19 Pandemic

“…Since 2018, we have been collecting data on PC clinician-reported challenges for in-person and video visits as part of an ongoing multisite randomized control trial of early integrated PC for patients with advanced lung cancer. 24 Here, we conducted a post hoc analysis of this data to describe trends in PC clinician-reported challenges for in-person and video visits before and during the COVID-19 pandemic across multiple U.S. cancer centers.…”