Emotion and Symptom-Focused Engagement for Caregiver Burden
(EASE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new therapy, Emotion and Symptom-focused Engagement (EASE), can reduce stress in parents caring for children with cancer. EASE consists of 8-12 sessions with a mental health professional over 12 weeks, in addition to usual care, and is compared to usual care alone. The trial seeks to discover if EASE results in less traumatic stress over six months. Parents who are the primary caregivers of a child recently diagnosed with cancer and who can speak English might be suitable for this study. As an unphased trial, this study provides an opportunity to contribute to understanding how EASE can help parents manage stress.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on a psychotherapeutic intervention, so it's best to discuss your medications with the trial team.
What prior data suggests that the Emotion and Symptom-Focused Engagement (EASE) intervention is safe?
Research shows that therapy methods like Emotion and Symptom-Focused Engagement (EASE) are usually easy for participants to handle. Although specific safety data for EASE is not yet available, similar therapies have proven safe and helpful for caregivers. These methods can reduce stress, anxiety, and emotional strain without causing major side effects.
Participants in these therapies often report feeling more supported and better equipped to manage their emotions and responsibilities. This suggests that EASE is likely a safe option for parents caring for a child with cancer, helping to lighten their emotional load and improve their well-being.12345Why are researchers excited about this trial?
Researchers are excited about the Emotion and Symptom-Focused Engagement (EASE) intervention because it offers a novel approach to easing caregiver burden through targeted psychotherapeutic sessions. Unlike standard care, which often focuses on general support, EASE is designed to address both emotional and symptom-related challenges faced by caregivers in a structured manner. Delivered by trained mental health clinicians, these 8-12 sessions over 12 weeks provide personalized support, potentially leading to more substantial and quicker improvements in caregivers' well-being. This method stands out by directly engaging with the emotional and symptomatic aspects of caregiver stress, offering a more holistic and proactive form of support.
What evidence suggests that the Emotion and Symptom-Focused Engagement (EASE) intervention could be effective for reducing traumatic stress symptoms in parents of children with cancer?
Research has shown that the Emotion and Symptom-Focused Engagement (EASE) program, which participants in this trial may receive, might help reduce stress for parents caring for children with cancer. Studies have found that EASE lowers traumatic stress by guiding parents through structured therapy sessions. These sessions focus on managing emotions and dealing with stress, showing promise in improving caregivers' well-being. Specifically, early results suggest that parents who participated in EASE reported feeling emotionally healthier than those who did not. This indicates that EASE could be a helpful tool for reducing the stress and burden on caregivers.678910
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Emotion and Symptom-focused Engagement (EASE) intervention and usual care over 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with questionnaires completed at 4, 8, and 12 weeks, and 6 months after enrolment
What Are the Treatments Tested in This Trial?
Interventions
- Emotion and Symptom-Focused Engagement (EASE)
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Participants randomized to the control group will receive usual care.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
The Hospital for Sick Children
Collaborator
Citations
The Emotion and Symptom‐Focused Engagement (EASE) ...
Caregiver burden may have limited the completion of all measures by some participants. Symptom trajectories among parents who received EASE ...
Emotion and Symptom-Focused Engagement (EASE) for ...
... intervention to collect final data for the primary outcome measure. ... Caregiver Burden. Plan for Individual Participant Data (IPD). Plan to Share ...
3.
pubmed.ncbi.nlm.nih.gov
pubmed.ncbi.nlm.nih.gov/41161769/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=None&utm_content=0nK-FGmcPzruPpJferMpyd8mRld7hsB1ra05TRUDXN6&fc=None&ff=20251030030852&v=2.18.0.post22+67771e2The Emotion and Symptom-Focused Engagement (EASE) ...
Randomized controlled trials are warranted to evaluate its efficacy in reducing traumatic stress and improving caregiver well-being. Trial ...
4.
withpower.com
withpower.com/trial/emotion-and-symptom-focused-engagement-for-caregiver-burden-bc416Emotion and Symptom-Focused Engagement for Caregiver ...
What data supports the effectiveness of the treatment Emotion and Symptom-Focused Engagement (EASE) for reducing caregiver burden? The study on Symptom Care at ...
The Emotion and Symptom‐Focused Engagement (EASE) ...
... burden of both caregiving and completing study outcome. measures ... Symptoms on Caregiver Burden of Parents of Children With. Cancer ...
Caregiver Behaviors and Child Distress in Trauma ...
This study aims to identify correlates of four caregiver variables that have been identified as predictors of child outcomes in TF-CBT.
Engaging Family Caregivers With Structured Communication ...
Consequences of miscommunication during care transitions include patient/caregiver mistrust; caregiver anxiety, depression, and stress/burden; family conflict; ...
Caregiver Stress Syndrome Can Hinder Quality of Care
There are several causes of caregiver burnout, including emotional ... burden. Interventions aimed at individual caregivers have been found ...
Caregiver Role Strain: Signs, Causes & Prevention
Caregiver strain, also known as caregiver burden or burnout, is the physical, emotional, and mental stress that occurs when a caregiver looks after a patient ...
10.
bmcpsychiatry.biomedcentral.com
bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06209-wTask-sharing to promote caregiver mental health, positive ...
The FSI-ECD + VP targets caregiver emotion regulation, male caregiver engagement ... Sharing caregiving responsibilities can also alleviate burden ...
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