Emotion and Symptom-Focused Engagement (EASE) for Caregivers
- Conditions
- Trauma and Stressor Related DisordersPediatric CancerCaregiver Burden
- Interventions
- Behavioral: Emotion and Symptom-Focused Engagement (EASE)
- Registration Number
- NCT06367556
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 306
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Emotion and Symptom-Focused Engagement (EASE) Participants randomized to the intervention group will receive the Emotion and Symptom-focused Engagement (EASE) intervention and usual care. EASE consists of 8-12 psychotherapeutic sessions (\~30-60 minutes each) delivered by a trained mental health clinician over 12 weeks.
- Primary Outcome Measures
Name Time Method The Stanford Acute Stress Reaction Questionnaire [SASRQ] 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.
- Secondary Outcome Measures
Name Time Method The PTSD Checklist for DSM-5 [PCL-5] 6-months PCL-5 is a 20-item self-report measure with a rating scale of 0-4 (total range 0-80) that assesses the presence and severity of traumatic stress symptoms. Higher scores reflect greater severity.
The SF-36v2 Health Survey 6-months SF-36v2 consists of eight scales yielding two summary measures: physical and mental health. It can be scored using both norm-based scoring (NBS) algorithms and the original 0-100 scoring system, where higher scores indicate better health status.
Patient Health Questionnaire [PHQ-9] 6-months PHQ-9 is a 9-item measure with a rating scale of 0-3 (total range 0-27) that assesses the presence and severity of depressive symptoms. Higher scores reflect greater depression severity.
Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC] 6-months CSE-CSC is a 10-item scale (standardized score 0-100) of to measure the extent of self-efficacy of the caregiver when contributing to patient self-care in the complex care context. Higher scores indicate higher self-efficacy.
Family Adaptability and Cohesion Evaluation Scales III [FACES-III] 6-months FACES-III is a 20-item measure with a rating scale of 1-5 that will be used to assess parent perceived family functioning. 10-items measure family cohesion and 10-items measure adaptability (range 10-50, respectively), with higher scores for each domain indicating greater connectivity or flexibility compared to disengagement or rigidity.
Clinical Evaluation Questionnaire [CEQ] 6-months CEQ is a 7-item patient-reported experience measure with a rating scale of 0-4 that will assess the perceived benefits that caregivers experience in their interactions with healthcare providers in domains relevant to advanced cancer. A total score is calculated by summing the item scores where higher scores reflect greater perceived benefit.
Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10] 6-months FAMCARE-10 was developed to measure family caregiver satisfaction with the care of patients with advanced cancer with a rating scale of 0 (dissatisfied) to 2 (satisfied) where higher total scores reflect greater satisfaction.
Trial Locations
- Locations (2)
Princess Margaret Cancer Centre - University Health Network
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada