Emotion and Symptom-Focused Engagement (EASE) for Caregivers: A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Parents of Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 2
- 主要终点
- The Stanford Acute Stress Reaction Questionnaire [SASRQ]
研究概览
简要总结
The goal of this Phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:
- Is EASE plus usual care associated with less severe traumatic stress symptoms over six months, measured by area under the curve, when compared to usual care alone in the parents of children diagnosed with cancer in the preceding six months?
For the primary outcome analysis, area under the curve will be calculated for each participant. The statistical significance of the difference between arms will also be evaluated. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Quantitative outcome assessors and data analysts will be blinded to participant treatment group. Blinding is not possible for trial participants, intervention providers, or pediatric oncology teams, as assignment cannot be hidden from these individuals.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-identified primary family caregiver/guardian (i.e., parent assuming the majority of care activities) of a child: i) <18yo; ii) diagnosed with a new or relapsed life-threatening cancer within the preceding six months (disease-type eligibility per the Pediatric Oncology Group of Ontario Networked Information System); and iii) receiving active cancer therapy;
- •Age ≥18 years; and,
- •Able to complete outcome measures and engage in EASE in English, which need not be their first language.
排除标准
- •Impairment in cognitive functioning or communication that would preclude participation in EASE sessions or outcome measure completion, as determined by the research team;
- •Receiving formal ongoing psychotherapy at the time of recruitment;
- •Active suicidal intention, based on an item in the Distress Assessment and Response Tool (DART) that has been widely used in suicidal intention screening in cancer; or,
- •Child not expected to survive past the duration of trial, as determined by the child's medical team.
结局指标
主要结局
The Stanford Acute Stress Reaction Questionnaire [SASRQ]
时间窗: 6-months
SASRQ is a 30-item self-report measure with a rating scale of 0-30 (total range 0-150) that assesses the presence and severity of traumatic stress symptoms. Higher scores reflect greater severity.
次要结局
- The PTSD Checklist for DSM-5 [PCL-5](6-months)
- The SF-36v2 Health Survey(6-months)
- Patient Health Questionnaire [PHQ-9](6-months)
- Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC](6-months)
- Family Adaptability and Cohesion Evaluation Scales III [FACES-III](6-months)
- Clinical Evaluation Questionnaire [CEQ](6-months)
- Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10](6-months)
研究者
Gary Rodin Research Team
Senior Scientist
University Health Network, Toronto