The mean number of palliative care visits was nearly halved for stepped-palliative care vs early palliative care in patients with advanced lung cancer.
A stepped care model for patients with advanced lung cancer was found to maintain patient-reported quality of life (QOL) with fewer visits over early palliative care, according to results from a prospective noninferiority trial (NCT03337399) published in JAMA Network.1
Investigators found that the mean number of palliative care visits (n = 2.4) for stepped palliative care was reduced by 2.3 visits vs early palliative care (4.7; 95% CI, –2.7 to –2.8; P < .001) by week 24.
Additionally, Functional Assessment of Cancer Therapy-Lung (FACT-L) scores were noninferior for stepped palliative care patients among those receiving early palliative care by week 24 (100.6 vs 97.8, respectively; lower 1-sided 95% confidence limit, –0.1; P < .001), and the rate of end-of-life care communication was noninferior as well. Noninferiority was not demonstrated for days in hospice, with an adjusted mean between stepped palliative care of 19.5 days vs 34.6 days in early palliative care (lower 1-sided 95% confidence limit, –25.1; P = .91).
“Palliative care interventions are delivered by specially trained palliative care physicians and advanced practitioners. Stepped care starts with low frequency visits, and when conditions worsen [eg, change in cancer trajectory, hospital admission], patients step up to more frequent visits. This improves utilization of resources,” Jennifer S. Temel, MD, FASCO, professor of medicine at Harvard Medical School and clinical director of Thoracic Oncology at Massachusetts General Hospital, stated in a news release on the trial findings.2 “Stepped palliative care enables more efficient use of resources and fewer office visits for patients compared to monthly office visits.”
Investigators enrolled adult patients diagnosed with either small cell lung cancer, non–small cell lung cancer, or mesothelioma within 12 weeks not being treated with curative intent. Patients were 1:1 randomized to receive either stepped (n = 250) or early palliative care (n = 257) between February 12, 2018 and December 15, 2022. FACT-L was completed 291 patients at 24 weeks, encompassing 73.9% of 394 eligible patients.
Initial palliative care visits were scheduled within 4 weeks of enrollment following patient group assignment. Following onset of the pandemic, palliative visits were conducted via videoconferencing vs in-person or phone call prior to the COVID-19 pandemic. Patients and their clinicians could defer, reinitiate, and request more frequent palliative visits upon request.
Palliative care physicians and advance practice practitioners conducted study visits (n = 34), with intervention fidelity ensured through an intervention guide and a 6-hour comprehensive training session.
Early palliative care–assigned patients were scheduled for visits every 4 weeks. Stepped palliative assigned patients started invention step 1, whereby they underwent an initial visit within 4 weeks of enrollment with subsequent visits scheduled only due to progression, toxicity, treatment discontinuation, or hospitalization. A QOL FACT-L measure was completed by step 1 patients for 6 weeks, up to a maximum of 18 months following enrollment.
Step 2 was conducted when a decrease in baseline score of 10 points or greater was observed, whereby patients were scheduled for visits every 4 weeks. A 10-point reduction in FACT-L score was associated with outcomes such as disease progression and was considered clinically meaningful.
The primary end point was QOL reflected by FACT-L score. Secondary end points include palliative care utilization, patient-reported communication about end-of-life care preferences, and length of hospice stay.
Step-up occurrence to step 2 occurred in 66 (26.4%) patients and 91 (36.4%) patients by weeks 24 and 48, respectively, for patients in the stepped palliative care group. A post hoc primary QOL end point lower 1-sided 97.5% confidence limit of –0.7 was calculated in accordance with a more stringent 1-sided 2.5% significance level test for noninferiority.
The mean number of palliative care visits (n = 3.8) for stepped palliative care was reduced by 3.9 visits vs early palliative care (7.7; 95% CI, –4.7 to –3.1; P < .001) by week 48. Among stepped and early palliative care groups, 11 and 27 patients, respectively, did not receive palliative care predominately due to transfer of care, withdrawal, or death.
“In conclusion, stepped palliative care holds considerable promise to increase the scalability of integrated palliative and oncology care by maintaining the effect of early palliative care on patients’ QOL and other salient patient-reported outcomes with fewer palliative care visits. As patients with metastatic cancers are living longer due to improvements in cancer therapeutics, they may have different palliative care needs while living with their cancer vs at the end of life. Identifying additional triggers to intensify palliative care near death is a potential next step to further optimize the stepped palliative care model,” Temel and coinvestigators concluded.1
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