Emotion and Symptom-Focused Engagement for Caregiver Burden

(EASE Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for parents over 18 who are the main caregivers for a child under 18 with new or relapsed life-threatening cancer diagnosed in the last six months. They must be able to engage in therapy and complete questionnaires in English.

Inclusion Criteria

I can complete health measures and participate in activities in English.

I am 18 years old or older.

I am the main caregiver for my child who has recently been diagnosed with a serious cancer and is under 18.

Treatment Details

Interventions

• Emotion and Symptom-Focused Engagement (EASE) (Behavioral Intervention)

Trial Overview The study tests Emotion and Symptom-Focused Engagement (EASE), a psychotherapeutic approach, plus usual care versus usual care alone. It measures traumatic stress symptoms over six months using questionnaires at multiple points.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to the control group will receive usual care.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Dr. Ronald D. Cohn

The Hospital for Sick Children

Chief Executive Officer since 2019

MD from University of Düsseldorf, Germany

Dr. Lennox Huang

The Hospital for Sick Children

Chief Medical Officer since 2016

MD from McGill University