Emotion and Symptom-Focused Engagement (EASE) for Caregivers
Recruiting
N/AInterventional Study
Trauma and Stressor Related DisordersPediatric CancerCaregiver Burden
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Supportive Care
Participants needed
306 (estimated)
Sponsor
University Health Network, Toronto · Other
Who this trial is looking for
This trial is looking for parents who take care of a child with cancer and want support to manage stress. Participants will complete questionnaires and can join interviews to share their experiences.
Are You a Good Fit for This Trial?
You may be able to join if
I am the primary caregiver for a child under 18 years old.
My child has been diagnosed with cancer in the last six months.
My child is currently receiving cancer treatment.
I am at least 18 years old.
I can complete questionnaires in English.
You may not be able to join if
I have difficulty with thinking or communication.
I am currently in therapy for mental health issues.
I have thoughts of harming myself.
My child is not expected to survive for the duration of the trial.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 unde…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* 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 Gr…
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.