Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303

Jennifer S. Temel, Jeff Sloan, Tyler Zemla, Joseph A. Greer, Vicki A. Jackson, Areej El-Jawahri, Mihir Kamdar, Arif Kamal, Craig D. Blinderman, Jacob Strand, Dylan Zylla, Christopher Daugherty, Muhummad Furqan, Jennifer Obel, Mohammad Razaq, Eric J. Roeland, Charles Loprinzi

Research output: Contribution to journalArticle

Abstract

Background: We conducted a multicenter, randomized trial of early integrated palliative and oncology care in patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies. Methods: We randomly assigned patients with newly diagnosed incurable cancer to early integrated palliative and oncology care (n = 195) or usual oncology care (n = 196) at sites through the Alliance for Clinical Trials in Oncology. Patients assigned to the intervention were expected to meet with a PC clinician at least monthly until death, whereas usual care patients consulted PC on request. The primary endpoint was the change in quality of life from baseline to week 12 per the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes included anxiety, depression, and communication about prognosis and end-of-life care. Results: Due to significant morbidity and a high proportion of measures that were not completed within the protocol window or for unknown reasons, the rate of missing data was high. We anticipated that 70% of patients (n = 280) would complete the FACT-G at baseline and week 12, but only 49.3% (n = 193/391) completed the measure. Delivery of the intervention was also suboptimal, as 14.9% (n = 29/195) of intervention patients had no PC visits by week 12. Intervention patients reported a mean 3.35 (standard deviation [SD] = 14.7) increase in FACT-G scores from baseline to week 12 compared with usual care patients who reported a 0.12 (SD = 12.7) increase from baseline (p = 0.10). Conclusion: This study highlights the difficulties of conducting multicenter trials of supportive care interventions in patients with advanced cancer. Clinical Trials Registration: NCT02349412.

Original languageEnglish (US)
Pages (from-to)922-929
Number of pages8
JournalJournal of Palliative Medicine
Volume23
Issue number7
DOIs
StatePublished - Jul 1 2020

Keywords

  • cancer
  • palliative care
  • quality of life

ASJC Scopus subject areas

  • Nursing(all)
  • Anesthesiology and Pain Medicine

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    Temel, J. S., Sloan, J., Zemla, T., Greer, J. A., Jackson, V. A., El-Jawahri, A., Kamdar, M., Kamal, A., Blinderman, C. D., Strand, J., Zylla, D., Daugherty, C., Furqan, M., Obel, J., Razaq, M., Roeland, E. J., & Loprinzi, C. (2020). Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303. Journal of Palliative Medicine, 23(7), 922-929. https://doi.org/10.1089/jpm.2019.0377