Actively Recruiting
Emotion and Symptom-Focused Engagement (EASE) for Caregivers
Led by University Health Network, Toronto · Updated on 2025-12-17
306
Participants Needed
2
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
T
The Hospital for Sick Children
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Emotion and Symptom-Focused Engagement (EASE) for Caregivers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identified primary family caregiver or guardian of a child under 18 years old diagnosed with new or relapsed life-threatening cancer within the last six months and receiving active cancer therapy
- Age 18 years or older
- Able to complete outcome measures and participate in EASE sessions in English
You will not qualify if you...
- Cognitive or communication impairment that prevents participation in EASE sessions or completing outcome measures
- Receiving formal ongoing psychotherapy at the time of recruitment
- Active suicidal intention as assessed by screening tool
- Child not expected to survive beyond the trial duration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario, Canada
Active, Not Recruiting
2
The Hospital for Sick Children
Toronto, Ontario, Canada
Actively Recruiting
Research Team
D
Dr. Lindsay Jibb, RN, PhD
CONTACT
E
Elham Hashemi, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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