Gary Rodin1,2,3, Carmine Malfitano4, Anne Rydall4, Aaron Schimmer5,6, Charles M Marmar7, Kenneth Mah4, Christopher Lo4,8,9, Rinat Nissim4,8, Camilla Zimmermann4,8,10,11. 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.
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.
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.
Authors: Gary Rodin; Dora Yuen; Ashley Mischitelle; Mark D Minden; Joseph Brandwein; Aaron Schimmer; Charles Marmar; Lucia Gagliese; Christopher Lo; Anne Rydall; Camilla Zimmermann Journal: Psychooncology Date: 2011-11-13 Impact factor: 3.894
Authors: Neil P Roberts; Neil J Kitchiner; Justin Kenardy; Lindsay Robertson; Catrin Lewis; Jonathan I Bisson Journal: Cochrane Database Syst Rev Date: 2019-08-08
Authors: Reka Schweighoffer; Andrea M Schumacher; Richard Blaese; Silke Walter; Sandra Eckstein Journal: Int J Environ Res Public Health Date: 2022-06-23 Impact factor: 4.614