Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Leukemia
- Sponsor
- University Health Network, Toronto
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Stanford Acute Stress Reaction Questionnaire (SASRQ)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Stanford Acute Stress Reaction Questionnaire (SASRQ)
Time Frame: 12 weeks
A 30-item reliable and valid self-report measure of traumatic stress symptoms.
Secondary Outcomes
- Edmonton Symptom Assessment System - Acute Leukemia (ESAS-AL)(24 hours)
- Memorial Symptom Assessment Scale (MSAS)(12 weeks)
- Brief Experiences in Close Relationships Scale (ECR-M16)(12 weeks)
- FAMCARE-P16(12 weeks)
- Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)(12 weeks)
- Beck Depression Inventory-II (BDI-II)(12 weeks)
- Brief Pain Inventory short form (BPI-sf)(12 weeks)
- Clinical Evaluation Questionnaire (CEQ)(12 weeks)