Clinical trial NCT02353559: Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia
Official title: Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Leukemia
Keywords: acute leukemia
traumatic stress
quality of life
symptom burden
psychosocial oncology
palliative care
intervention
hematological malignancies
supportive care
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
First posted: 2015-02-02
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility of an individual psychological and physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia.

Detailed description: This study involves the pilot-testing of a newly developed, brief manualized individual psychotherapy and physical symptom control intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia. The purpose of this study is to conduct a two-arm randomized pilot trial (RPT) to test the feasibility, acceptability, and preliminary efficacy of EASE against usual care (UC) for the reduction of traumatic stress and physical symptom burden in patients with acute leukemia. Usual care for individuals with acute leukemia treated at the Princess Margaret Cancer Centre includes referral for non-standardized, and primarily instrumental, psychosocial care and palliative care service as needed.

The design will be an unblinded RPT consisting of two conditions (EASE and UC), with a baseline assessment and follow-ups at 4, 8, and 12 weeks. The trial will take place at the Princess Margaret Cancer Centre, University Health Network; a comprehensive cancer center in Toronto, Canada. Participants will be newly diagnosed with acute leukemia, within one month of diagnosis and/or admission to hospital for treatment with curative intent.

Eligibility criteria: Inclusion Criteria:

* new or relapsed diagnosis of acute leukemia (an amendment to allow recruitment of relapsed patients was approved on 24-Sep-2015, although no relapsed patients were ultimately recruited)
* will be receiving induction chemotherapy with curative intent and within 1 month of diagnosis and/or admission to hospital at the Princess Margaret Cancer Centre
* age ≥ 18 years
* fluency in English
* no cognitive impairment indicated in the medical record, communicated by the hematology clinical team, or determined by research staff at recruitment.

Exclusion Criteria:

* inability to pass the cognitive screening test (Short Orientation-Memory Concentration Test \[SOMC\] score \<20)
* actively receiving psychological/psychiatric counseling or palliative care services from the Department of Psychosocial Oncology and Palliative Care (POPC), now called the Department of Supportive Care, at the Princess Margaret Cancer Centre at the time of recruitment to this study

Primary outcomes:
measure: Stanford Acute Stress Reaction Questionnaire (SASRQ)
timeFrame: 12 weeks
Secondary outcomes:
measure: Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
timeFrame: 12 weeks
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 12 weeks
measure: Brief Pain Inventory short form (BPI-sf)
timeFrame: 12 weeks
measure: Memorial Symptom Assessment Scale (MSAS)
timeFrame: 12 weeks
measure: Brief Experiences in Close Relationships Scale (ECR-M16)
timeFrame: 12 weeks
measure: FAMCARE-P16
timeFrame: 12 weeks
measure: Clinical Evaluation Questionnaire (CEQ)
timeFrame: 12 weeks
measure: Edmonton Symptom Assessment System - Acute Leukemia (ESAS-AL)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Gary Rodin, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Camilla Zimmermann, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodin G, Yuen D, Mischitelle A, Minden MD, Brandwein J, Schimmer A, Marmar C, Gagliese L, Lo C, Rydall A, Zimmermann C. Traumatic stress in acute leukemia. Psychooncology. 2013 Feb;22(2):299-307. doi: 10.1002/pon.2092. Epub 2011 Nov 13.
citation: Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.
citation: Zimmermann C, Yuen D, Mischitelle A, Minden MD, Brandwein JM, Schimmer A, Gagliese L, Lo C, Rydall A, Rodin G. Symptom burden and supportive care in patients with acute leukemia. Leuk Res. 2013 Jul;37(7):731-6. doi: 10.1016/j.leukres.2013.02.009. Epub 2013 Mar 11.
citation: Nissim R, Zimmermann C, Minden M, Rydall A, Yuen D, Mischitelle A, Gagliese L, Schimmer A, Rodin G. Abducted by the illness: a qualitative study of traumatic stress in individuals with acute leukemia. Leuk Res. 2013 May;37(5):496-502. doi: 10.1016/j.leukres.2012.12.007. Epub 2013 Jan 24.
citation: Nissim R, Rodin G, Schimmer A, Minden M, Rydall A, Yuen D, Mischitelle A, Fitzgerald P, Lo C, Gagliese L, Zimmermann C. Finding new bearings: a qualitative study on the transition from inpatient to ambulatory care of patients with acute myeloid leukemia. Support Care Cancer. 2014 Sep;22(9):2435-43. doi: 10.1007/s00520-014-2230-3. Epub 2014 Apr 5.
citation: Zimmermann C, Seccareccia D, Clarke A, Warr D, Rodin G. Bringing palliative care to a Canadian cancer center: the palliative care program at Princess Margaret Hospital. Support Care Cancer. 2006 Oct;14(10):982-7. doi: 10.1007/s00520-006-0093-y. Epub 2006 Jun 27.
citation: Rodin G, Deckert A, Tong E, Le LW, Rydall A, Schimmer A, Marmar CR, Lo C, Zimmermann C. Traumatic stress in patients with acute leukemia: A prospective cohort study. Psychooncology. 2018 Feb;27(2):515-523. doi: 10.1002/pon.4488. Epub 2017 Aug 10.
citation: Shaulov A, Rodin G, Popovic G, Caraiscos VB, Le LW, Rydall A, Schimmer AD, Zimmermann C. Pain in patients with newly diagnosed or relapsed acute leukemia. Support Care Cancer. 2019 Aug;27(8):2789-2797. doi: 10.1007/s00520-018-4583-5. Epub 2018 Dec 8.
citation: Rodin G, Malfitano C, Rydall A, Schimmer A, Marmar CM, Mah K, Lo C, Nissim R, Zimmermann C. 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. 2020 Jan;28(1):163-176. doi: 10.1007/s00520-019-04723-2. Epub 2019 Apr 17.