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RECRUITING
NCT06367556
NA

Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

306

Start Date

2025-02-14

Completion Date

2028-10-01

Last Updated

2025-12-17

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

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.

Locations (2)

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada