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

Rodin, Gary, Malfitano, Carmine, Rydall, Anne, Schimmer, Aaron, Marmar, Charles M., Mah, Kenneth, Lo, Christopher, Nissim, Rinat, and Zimmermann, Camilla (2020) Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia. Supportive Care in Cancer, 28. pp. 163-176.

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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.

Item ID: 69199
Item Type: Article (Research - C1)
ISSN: 1433-7339
Keywords: Hematology; Cancer; Acute leukemia; Traumatic stress; Psychosocial intervention; Early palliative care
Copyright Information: © Springer-Verlag GmbH Germany, part of Springer Nature 2019
Funders: Canadian Cancer Society Research Institute (CCSRI), Princess Margaret Cancer Centre (PMCC) Canada, Princess Margaret Cancer Foundation (PMCF) Canada, University Health Network (UHN) Canada, Ontario Ministry of Health and Long-term Care (OMHLC)
Projects and Grants: CCSRI grant no. 702603
Date Deposited: 30 Aug 2021 23:24
FoR Codes: 52 PSYCHOLOGY > 5203 Clinical and health psychology > 520304 Health psychology @ 100%
SEO Codes: 20 HEALTH > 2001 Clinical health > 200105 Treatment of human diseases and conditions @ 100%
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