Pilot Study of a Novel Psychotherapeutic Intervention for Caregivers of Patients With Acute Leukemia: Emotion and Symptom-focused Engagement for Caregivers (EASE-CG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Stanford Acute Stress Reaction Questionnaire (SASRQ-II)
研究概览
简要总结
The purpose of this study is to test the feasibility and acceptability of an adapted psychosocial intervention, called Emotion and Symptom-focused Engagement for Caregivers (EASE-CG), to reduce traumatic stress symptoms and other psychological distress and increase well-being in primary caregivers of patients newly diagnosed with acute leukemia.
详细描述
Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) is a brief psychotherapeutic intervention designed for primary caregivers of patients newly diagnosed with acute leukemia (AL). The EASE-CG intervention was adapted from a previous psychotherapeutic intervention for adult patients newly diagnosed with AL, called Emotion and Symptom-focused Engagement (EASE). In a previous pilot trial, EASE was associated with reductions in traumatic stress and physical symptom burden in adult patients with AL.
EASE-CG is a sub-study of a multi-center, longitudinal, mixed-methods study on the experience of traumatic stress in primary caregivers of patients newly diagnosed with AL within three months of admission to the hospital (Main study). The purpose of this sub-study is to conduct a non-randomized, mixed-methods pilot study to test the feasibility and acceptability of EASE-CG. A subset of caregivers of pediatric patients from the Main study will be approached to participate in EASE-CG. Quantitative measures will be administered at baseline, 1, 3 (primary endpoint), 6, 9, and 12 months (Main study endpoint). Participants may be invited to brief, semi-structured interviews.
The study will take place at the Hospital for Sick Children; the largest leukemia treatment center in Canada for pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Self-identified primary caregiver (i.e., person assuming the majority of care activities) or co-primary caregiver (i.e., assuming at least 40% of care activities alongside another co-primary caregiver) of an adult or pediatric patient who is newly diagnosed with acute leukemia within 3 months of admission to the Princess Margaret Cancer Centre or the Hospital for Sick Children
- •Age ≥18 years
- •Fluency in English
排除标准
- 未提供
研究组 & 干预措施
EASE-CG Intervention
Participants will be offered one EASE-CG therapy session every week for up to 12 weeks. Each session will last for approximately 30-60 minutes, delivered by a trained therapist at our center. Frequency and/or length of sessions may vary to accommodate the needs and availability of each participant.
Outcomes will be assessed at baseline, 1, 3, 6, 9, and 12 months. Participants may be invited to brief, semi-structured interviews.
干预措施: EASE-CG (Behavioral)
结局指标
主要结局
Stanford Acute Stress Reaction Questionnaire (SASRQ-II)
时间窗: 12 weeks
A 30-item reliable, valid, and widely used self-report measure assessing the severity of traumatic stress symptoms over the past four weeks. Total SASRQ scores may range from 0-150, with higher scores indicating increasingly severe traumatic stress symptoms. This measure has been updated to be Diagnostic and Statistical Manual of Mental Disorders (DSM-5)-concordant for acute stress disorder symptoms.
PTSD Checklist for DSM-5 (PCL-5)
时间窗: 12 weeks
A 20-item reliable and valid self-report measure of the presence and severity of post-traumatic stress disorder (PTSD) symptoms over the past month. Total PCL-5 scores may range from 0-80, with higher scores indicating increasingly severe PTSD symptoms. This DSM-5-concordant measure has been included to help validate the DSM-5-concordant version of the SASRQ.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(12 weeks)
- Enhancing Recovery In Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI)(12 weeks)
- Traditional Masculinity-Femininity (TMF) Scale(Baseline)
- Brief Experiences in Close Relationships Scale (ECR-M16)(12 weeks)
- Caregiver Reaction Assessment (CRA) Scale(12 weeks)
- Family Satisfaction with End-of-Life Care (FAMCARE) Scale(12 weeks)