Emotion and Symptom-Focused Engagement for Caregiver Burden

(EASE Trial)

Not yet recruiting at 1 trial location

Overseen By Dr. Lindsay Jibb, RN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Cognitive impairment, Ongoing psychotherapy, Suicidal intention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

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. ^{1 2 3 4 5}

Why 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. ^{6 7 8 9 10}

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

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Emotion and Symptom-focused Engagement (EASE) intervention and usual care over 12 weeks

12 weeks

8-12 sessions (in-person or virtual)

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

6 months

4 visits (virtual)

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?

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+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12571586/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06367556

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+67771e2

The 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-bc416

Emotion 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 ...

5. researchgate.net researchgate.net/publication/397047106_The_Emotion_and_Symptom-Focused_Engagement_EASE_Psychotherapeutic_Intervention_for_Parents_of_Children_With_Acute_Leukemia_A_Feasibility_Trial

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8765780/

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.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK603405/

Engaging Family Caregivers With Structured Communication ... Consequences of miscommunication during care transitions include patient/caregiver mistrust; caregiver anxiety, depression, and stress/burden; family conflict; ...

8. medcentral.com medcentral.com/geriatrics/caregiver-stress-syndrome-can-hinder-quality-of-care

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 ...

9. creyos.com creyos.com/blog/caregiver-role-strain

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-w

Task-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 ...