Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Stanford Acute Stress Reaction Questionnaire (SASRQ)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Usual Care
Usual care
EASE
Patients assigned to the intervention arm will receive 8 - 12 psychotherapy sessions lasting 30 - 60 minutes each, delivered by a trained therapist at our center. Patients will receive specialized symptom control from a nurse/physician team in our Palliative Care Service, when indicated by routine symptom screening.
干预措施: EASE (Behavioral)
结局指标
主要结局
Stanford Acute Stress Reaction Questionnaire (SASRQ)
时间窗: 12 weeks
A 30-item reliable and valid self-report measure of traumatic stress symptoms.
次要结局
- 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)