Trials / Recruiting
RecruitingNCT06367556
Emotion and Symptom-Focused Engagement (EASE) for Caregivers
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
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 306 (estimated)
- Sponsor
- University Health Network, Toronto · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-02-14
- Primary completion
- 2027-10-01
- Completion
- 2028-10-01
- First posted
- 2024-04-16
- Last updated
- 2025-12-17
Locations
2 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT06367556. Inclusion in this directory is not an endorsement.