Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Sponsor
University Health Network, Toronto
Study ID
NCT06367556
Status
Recruiting
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Conditions

  • Caregiver Burden
  • Pediatric Cancer
  • Trauma and Stressor Related Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Emotion and Symptom-Focused Engagement (EASE) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Apr 16, 2024
Start date
Feb 14, 2025
Status verified
Dec 2025
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
306 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Treatment
    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.
  • No Intervention: Usual Care
    Participants randomized to the control group will receive usual care.

Primary Outcome Measure

The Stanford Acute Stress Reaction Questionnaire [SASRQ] [ Time Frame: 6-months ]

Central Contacts

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