Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia

Gary Rodin^{1

2

3}, Carmine Malfitano⁴, Anne Rydall⁴, Aaron Schimmer^{5

6}, Charles M Marmar⁷, Kenneth Mah⁴, Christopher Lo^{4

8

9}, Rinat Nissim^{4

8}, Camilla Zimmermann^{4

8

10

11}

Affiliations

¹ Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada. gary.rodin@uhn.ca.
² Department of Psychiatry, University of Toronto, 250 College Street, 8th Floor, Toronto, Ontario, M5T 1R8, Canada. gary.rodin@uhn.ca.
³ Global Institute of Psychosocial, Palliative and End-of-Life Care (GIPPEC), University of Toronto and Princess Margaret Cancer Centre, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada. gary.rodin@uhn.ca.
⁴ Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.
⁵ Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, 7th Floor, 610 University Avenue, Toronto, Ontario, M5G 2M9, Canada.
⁶ Department of Medical Biophysics, University of Toronto, 101 College Street, Suite 15-701, Toronto, Ontario, M5G 1L7, Canada.
⁷ Department of Psychiatry, New York University Langone Medical Center, 550 First Avenue, New York, NY, 10016, USA.
⁸ Department of Psychiatry, University of Toronto, 250 College Street, 8th Floor, Toronto, Ontario, M5T 1R8, Canada.
⁹ Department of Psychology, University of Guelph-Humber, 207 Humber College Blvd., Toronto, Ontario, M9W 5L7, Canada.
¹⁰ Global Institute of Psychosocial, Palliative and End-of-Life Care (GIPPEC), University of Toronto and Princess Margaret Cancer Centre, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.
¹¹ Department of Medicine, University of Toronto, 190 Elizabeth Street, R. Fraser Elliott Building, 3-805, Toronto, Ontario, M5G 2C4, Canada.

PMID: 31001692
DOI: 10.1007/s00520-019-04723-2

Clinical Trial

Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia

Gary Rodin et al. Support Care Cancer. 2020 Jan.

. 2020 Jan;28(1):163-176.

doi: 10.1007/s00520-019-04723-2. Epub 2019 Apr 17.

Authors

Affiliations

¹ Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada. gary.rodin@uhn.ca.
² Department of Psychiatry, University of Toronto, 250 College Street, 8th Floor, Toronto, Ontario, M5T 1R8, Canada. gary.rodin@uhn.ca.
³ Global Institute of Psychosocial, Palliative and End-of-Life Care (GIPPEC), University of Toronto and Princess Margaret Cancer Centre, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada. gary.rodin@uhn.ca.
⁴ Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.
⁵ Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, 7th Floor, 610 University Avenue, Toronto, Ontario, M5G 2M9, Canada.
⁶ Department of Medical Biophysics, University of Toronto, 101 College Street, Suite 15-701, Toronto, Ontario, M5G 1L7, Canada.
⁷ Department of Psychiatry, New York University Langone Medical Center, 550 First Avenue, New York, NY, 10016, USA.
⁸ Department of Psychiatry, University of Toronto, 250 College Street, 8th Floor, Toronto, Ontario, M5T 1R8, Canada.
⁹ Department of Psychology, University of Guelph-Humber, 207 Humber College Blvd., Toronto, Ontario, M9W 5L7, Canada.
¹⁰ Global Institute of Psychosocial, Palliative and End-of-Life Care (GIPPEC), University of Toronto and Princess Margaret Cancer Centre, 610 University Avenue, 16th Floor, Toronto, Ontario, M5G 2M9, Canada.
¹¹ Department of Medicine, University of Toronto, 190 Elizabeth Street, R. Fraser Elliott Building, 3-805, Toronto, Ontario, M5G 2C4, Canada.

PMID: 31001692
DOI: 10.1007/s00520-019-04723-2

Abstract

Purpose: We designed a novel, manualized intervention called Emotion And Symptom-focused Engagement (EASE) for acute leukemia (AL) and report here on a phase II randomized controlled trial (RCT) to assess its feasibility and preliminary efficacy.

Methods: Patients were recruited within 1 month of hospital admission and randomized to EASE plus usual care (UC) or UC alone. EASE includes (1) EASE-psy, a tailored psychotherapy delivered over 8 weeks, and (2) EASE-phys, weekly physical symptom screening over 8 weeks to trigger early palliative care. The primary outcome was traumatic stress symptoms; secondary outcomes included physical symptom burden and quality of life. Assessments were conducted at baseline and at 4, 8, and 12 weeks. Between-group differences were evaluated using multilevel modeling.

Results: Forty-two patients were randomized to EASE (n = 22) or UC (n = 20), with 76% retention at 12 weeks. Predefined feasibility outcomes were met: 86% (19/22) of EASE participants completed ≥ 50% of EASE-psy sessions (goal ≥ 64%); 100% received Edmonton Symptom Assessment System (ESAS, modified for AL) screenings, 64% (14/22) of whom completed ≥ 50% of planned screenings (goal ≥50%); and 100% with scores ≥ 4/10 on any physical ESAS-AL item had ≥ 1 meeting with the EASE-phys team (goal 100%). Significant treatment-group differences favoring EASE were observed in traumatic stress symptoms at 4 and 12 weeks, and pain intensity and interference at 12 weeks (all p < .05).

Conclusions: EASE is feasible in patients newly diagnosed with AL and shows promise of effectiveness. These results warrant a larger RCT to provide evidence for its more routine use as a standard of care.

Keywords: Acute leukemia; Cancer; Early palliative care; Hematology; Psychosocial intervention; Traumatic stress.

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References

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1. Rodin G, Deckert A, Tong E, le LW, Rydall A, Schimmer A, Marmar CR, Lo C, Zimmermann C (2018) Traumatic stress in patients with acute leukemia: a prospective cohort study. Psychooncology 27(2):515–523 - DOI
1. American Psychiatric Association (APA) (2000) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR). American Psychiatric Association, Washington, DC - DOI
1. Zimmermann C, Yuen D, Mischitelle A, Minden MD, Brandwein JM, Schimmer A, Gagliese L, Lo C, Rydall A, Rodin G (2013) Symptom burden and supportive care in patients with acute leukemia. Leuk Res 37(7):731–736 - DOI

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Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia

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Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia

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