Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia

Acute Leukemia Clinical Trial

— EASE  

Official title:

Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02353559
• Other study ID #: 13-6631
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: November 2016

Study information

• Verified date: September 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• Acute Leukemia
• Leukemia

Intervention

Behavioral:
• EASE
EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Cancer Society Research Institute (CCSRI)

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View 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. — View 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. — View 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 — View 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. — View 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. — View 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. Epub 2006 Jun 27. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stanford Acute Stress Reaction Questionnaire (SASRQ)	A 30-item reliable and valid self-report measure of traumatic stress symptoms.	12 weeks
Secondary	Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)	A 40-item reliable and valid self-report measure of overall quality of life, including 12 items that assess spiritual well-being, spiritual meaning and peace, and faith.	12 weeks
Secondary	Beck Depression Inventory-II (BDI-II)	A 21-item reliable and valid self-report measure of the intensity of depressive symptoms, consistent with the DSM-V criteria for major depressive disorder.	12 weeks
Secondary	Brief Pain Inventory short form (BPI-sf)	A 9-item reliable and valid self-report measure that assesses pain severity and the impact of pain on daily functioning.	12 weeks
Secondary	Memorial Symptom Assessment Scale (MSAS)	A 32-item reliable and valid self-report inventory assessing the presence and severity of 26 common physical symptoms and 6 psychological symptoms of cancer. The scale has been adapted to reduce burden. A shortened version that omits frequency of symptoms and treatment, and satisfaction with treatment for each symptom was used.	12 weeks
Secondary	Brief Experiences in Close Relationships Scale (ECR-M16)	A 16-item reliable and valid self-report measure of attachment security.	12 weeks
Secondary	FAMCARE-P16	A 16-item reliable and valid self-report measure of patient satisfaction with healthcare providers.	12 weeks
Secondary	Clinical Evaluation Questionnaire (CEQ)	A 7-item measure developed for this study to evaluate the extent to which patients felt emotionally supported by the clinical services provided.	12 weeks
Secondary	Edmonton Symptom Assessment System - Acute Leukemia (ESAS-AL)	A 14-item symptom severity assessment measure adapted for patients with acute leukemia to include prevalent and treatable symptoms in this population: mouth sores, diarrhea, itching, constipation, and insomnia. ESAS-AL was used as a screening tool as part of the clinical intervention, and was added as an outcome later in the trial (13-Apr-2016).	24 hours