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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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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.

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Acknowledgments

GR holds the University of Toronto/University Health Network Harold and Shirley Lederman Chair in Psychosocial Oncology and Palliative Care, and CZ holds the Rose Family Chair in Supportive Care from the University of Toronto. The authors would like to thank the clinical, research, and administrative staff who contributed to this project, especially the hematology staff, including clinical associates Drs. Andrzej Lutynski, Amr Rostom, and Dina Khalef; our EASE-phys palliative care treatment team, including Patricia Murphy-Kane, Kelly McGuigan, Jocelyn Brown, Christine Cameron, and Drs. John Bryson, Ernie Mak, Breffni Hannon, and Ahmed Al-Awamer; and our research staff and students, including Abigail Magpayo, Sarah Watt, Ekaterina An, Erica Wennberg, Beth Edwards, Amy Deckert, Loreto Fernandez, Dorothy Wong, and Ina Delphra. We are especially grateful to our study participants and their families who gave their time and effort to help us better understand the experience of living with acute leukemia.

Funding

This trial was funded by the Canadian Cancer Society Research Institute (CCSRI grant no. 702603; GR and CZ, Co-Principal Investigators). This research was also supported in part by the Princess Margaret Cancer Centre and Princess Margaret Cancer Foundation, University Health Network, Toronto, Ontario, Canada, and the Ontario Ministry of Health and Long-term Care.

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Authors and 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, Carmine Malfitano, Anne Rydall, Kenneth Mah, Christopher Lo, Rinat Nissim & Camilla Zimmermann

  2. Department of Psychiatry, University of Toronto, 250 College Street, 8th Floor, Toronto, Ontario, M5T 1R8, Canada

    Gary Rodin, Christopher Lo, Rinat Nissim & Camilla Zimmermann

  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 & Camilla Zimmermann

  4. Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre, University Health Network, 7th Floor, 610 University Avenue, Toronto, Ontario, M5G 2M9, Canada

    Aaron Schimmer

  5. Department of Medical Biophysics, University of Toronto, 101 College Street, Suite 15-701, Toronto, Ontario, M5G 1L7, Canada

    Aaron Schimmer

  6. Department of Psychiatry, New York University Langone Medical Center, 550 First Avenue, New York, NY, 10016, USA

    Charles M. Marmar

  7. Department of Psychology, University of Guelph-Humber, 207 Humber College Blvd., Toronto, Ontario, M9W 5L7, Canada

    Christopher Lo

  8. Department of Medicine, University of Toronto, 190 Elizabeth Street, R. Fraser Elliott Building, 3-805, Toronto, Ontario, M5G 2C4, Canada

    Camilla Zimmermann

Authors
  1. Gary Rodin
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  2. Carmine Malfitano
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  3. Anne Rydall
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  4. Aaron Schimmer
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  6. Kenneth Mah
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  7. Christopher Lo
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  8. Rinat Nissim
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Contributions

Conception and design: GR, CZ, with contributions from CM, CL, AR, AS, and CMM

Administrative support: CM, AR

Provision of study materials or patients: AS

Trial implementation, acquisition, and assembly of data: CM

Analysis and interpretation of data: KM, CM, CL, GR, CZ, AR

Manuscript writing: All authors

Final approval of manuscript to be published: All authors

Corresponding author

Correspondence to Gary Rodin.

Ethics declarations

This pilot trial received approval from the University Health Network (UHN) Research Ethics Board (REB No. 13–6631-CE) and was monitored by the UHN Data Safety Monitoring Board. Informed consent was obtained from all individual participants included in the study. The trial was registered with ClinicalTrials.gov (Identifier: NCT02353559).

Conflict of interest

AS reports personal fees and grants outside this submitted work from Novartis, Takeda Pharmaceuticals, Otsuka Pharmaceutical, Jazz Pharmaceuticals, Medivir, and Abbvie. The remaining authors declare no conflicts of interest.

Disclaimer

The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The Co-Principal Investigators had full access to all study data and had final responsibility for the decision to submit for publication. They agree to allow the journal to review the data if requested. This manuscript contains original material.

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Rodin, G., Malfitano, C., Rydall, A. et al. Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia. Support Care Cancer 28, 163–176 (2020). https://doi.org/10.1007/s00520-019-04723-2

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