Phase II Trial of Symptom Screening With Targeted Early Palliative Care for Patients With Advanced Cancer

Authors:
Camilla Zimmermann Department of Supportive Care, and
Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Palliative Medicine, Department of Medicine, and
Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto;

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 MD, PhD, FRCPC
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Ashley Pope Department of Supportive Care, and

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Breffni Hannon Department of Supportive Care, and
Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Palliative Medicine, Department of Medicine, and

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Monika K. Krzyzanowska Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Gary Rodin Department of Supportive Care, and
Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto;

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Madeline Li Department of Supportive Care, and
Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto;

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Doris Howell Department of Supportive Care, and
Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Faculty of Nursing, University of Toronto, Toronto;

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Jennifer J. Knox Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Natasha B. Leighl Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Srikala Sridhar Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Amit M. Oza Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Rebecca Prince Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Stephanie Lheureux Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Aaron R. Hansen Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Anne Rydall Department of Supportive Care, and

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Brittany Chow Department of Supportive Care, and

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Leonie Herx Division of Palliative Medicine, Department of Medicine, Queen’s University, Kingston;

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Christopher M. Booth Division of Medical Oncology, Kingston Health Sciences Centre, Kingston;
Department of Oncology, Queen’s University, Kingston;
Division of Cancer Care and Epidemiology, Queen's University Cancer Research Institute, Kingston; and

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Deborah Dudgeon Division of Medical Oncology, Kingston Health Sciences Centre, Kingston;

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Neesha Dhani Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Geoffrey Liu Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Philippe L. Bedard Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto;
Division of Medical Oncology,
Division of Medical Oncology and Haematology, Princess Margaret Cancer Centre, University Health Network, Toronto;

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Jean Mathews Department of Supportive Care, and
Division of Palliative Medicine, Department of Medicine, and

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Nadia Swami Department of Supportive Care, and

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Lisa W. Le Department of Biostatistics, Princess Margaret Cancer Centre, University Health Network, Toronto, Canada.

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Background: Routine early palliative care (EPC) improves quality of life (QoL) for patients with advanced cancer, but it may not be necessary for all patients. We assessed the feasibility of Symptom screening with Targeted Early Palliative care (STEP) in a phase II trial. Methods: Patients with advanced cancer were recruited from medical oncology clinics. Symptoms were screened at each visit using the Edmonton Symptom Assessment System-revised (ESAS-r); moderate to severe scores (screen-positive) triggered an email to a palliative care nurse, who called the patient and offered EPC. Patient-reported outcomes of QoL, depression, symptom control, and satisfaction with care were measured at baseline and at 2, 4, and 6 months. The primary aim was to determine feasibility, according to predefined criteria. Secondary aims were to assess whether STEP identified patients with worse patient-reported outcomes and whether screen-positive patients who accepted and received EPC had better outcomes over time than those who did not receive EPC. Results: In total, 116 patients were enrolled, of which 89 (77%) completed screening for ≥70% of visits. Of the 70 screen-positive patients, 39 (56%) received EPC during the 6-month study and 4 (6%) received EPC after the study end. Measure completion was 76% at 2 months, 68% at 4 months, and 63% at 6 months. Among screen-negative patients, QoL, depression, and symptom control were substantially better than for screen-positive patients at baseline (all P<.0001) and remained stable over time. Among screen-positive patients, mood and symptom control improved over time for those who accepted and received EPC and worsened for those who did not receive EPC (P<.01 for trend over time), with no difference in QoL or satisfaction with care. Conclusions: STEP is feasible in ambulatory patients with advanced cancer and distinguishes between patients who remain stable without EPC and those who benefit from targeted EPC. Acceptance of the triggered EPC visit should be encouraged.

ClinicalTrials.gov identifier: NCT04044040.

Submitted November 4, 2020; revision received December 24, 2020; accepted for publication December 24, 2020. Published online September 7, 2021.

Previous presentation: This study was presented in part at the 2019 ASCO Annual Meeting; May 31–June 4, 2019; Chicago, Illinois. Abstract 11604.

Disclosures: Dr. Lheureux has disclosed being a principal investigator on clinical trials for Merck, GlaxoSmithKline, AstraZeneca, Roche, and Regeneron, and receiving honoraria for serving on advisory boards for GlaxoSmithKline, AstraZeneca, and Eisai. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Funding: This research was funded by the Canadian Institutes of Health Research (grant number 152996 to Dr. Zimmermann), the Mount Sinai Hospital University Health Network Academic Medical Organization Innovation fund, and the Ontario Ministry of Health and Long-Term Care. Dr. Zimmermann is supported by the Rose Family Chair in Palliative Medicine and Supportive Care, Department of Medicine, University of Toronto.

Correspondence: Camilla Zimmermann, MD, PhD, FRCPC, Department of Supportive Care, Princess Margaret Cancer Centre, 620 University Ave, 12-300, Toronto, ON M5G 2C1, Canada. Email: camilla.zimmermann@uhn.ca

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