Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Emotion and Symptom-Focused Engagement (EASE)
  EASE sessions are directed to provide relational support, affect regulation, and problem-solving related to cancer in the child, to changes in spousal, family, and other relationships, and to the burden of multiple individual and family responsibilities.

Первичные конечные точки

• The Stanford Acute Stress Reaction Questionnaire [SASRQ] [Срок оценки: 6-months]

Вторичные конечные точки (7)

• The PTSD Checklist for DSM-5 [PCL-5] [Срок оценки: 6-months]
• The SF-36v2 Health Survey [Срок оценки: 6-months]
• Patient Health Questionnaire [PHQ-9] [Срок оценки: 6-months]
• Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC] [Срок оценки: 6-months]
• Family Adaptability and Cohesion Evaluation Scales III [FACES-III] [Срок оценки: 6-months]
• Clinical Evaluation Questionnaire [CEQ] [Срок оценки: 6-months]
• Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10] [Срок оценки: 6-months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 2 центра

• Princess Margaret Cancer Centre - University Health Network — Toronto
• The Hospital for Sick Children — Toronto

Идентификаторы

NCT: NCT06367556 · 4542

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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