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

Abstract

IntroductionIntegrating 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 analysisWe 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 disseminationThe 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 numberNCT03337399.

Stepped Palliative Care for Patients With Advanced Lung Cancer

“…Self-reported measures were described previously and included a sociodemographic questionnaire and validated measures scored in accordance with published guidelines (eAppendix 1 in Supplement 3). [30][31][32][33][34][35][36][37] Participants could complete self-report measures on paper in person or via mail, electronically, or over the telephone at designated time points with a window of ±21 days. Measures that were not publicly available in Spanish were translated forward and backward by a Spanish-speaking clinician.…”

“…We amended the protocol to increase the sample size to account for missing data and to allow remote consenting and video visits after the onset of the COVID-19 pandemic. The protocol was published previously, 30 and the trial protocol and statistical analysis plan are available in Supplement 1 and Supplement 2.…”

Clinician Perspectives on Palliative Care for People with Hepatocellular Carcinoma: Facilitators of and Barriers to Referral

“…One way to further support this phenomenon would be to identify specific patient and family needs at these milestones. There is indeed growing interest in the field of palliative oncology in the idea that palliative care can be delivered at specific disease-based milestones, with increased intensity and frequency of care delivery for those that are identified as having a higher level of need based on the use of a screening tool [30].…”

Use of Machine Learning to Optimize Referral for Early Palliative Care: Are Prognostic Predictions Enough?

“…19-21 Prospective studies ought to evaluate the use of ML prognostic models to facilitate palliative care referral tailored to patients' needs, including consideration of patient-reported outcomes to triage palliative care services. 22,23…”