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Trial Title:
Emotion and Symptom-Focused Engagement (EASE) for Caregivers
NCT ID:
NCT06367556
Condition:
Trauma and Stressor Related Disorders
Pediatric Cancer
Caregiver Burden
Conditions: Official terms:
Caregiver Burden
Trauma and Stressor Related Disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Masking description:
Quantitative outcome assessors and data analysts will be blinded to participant treatment
group. Blinding is not possible for trial participants, intervention providers, or
pediatric oncology teams, as assignment cannot be hidden from these individuals.
Intervention:
Intervention type:
Behavioral
Intervention name:
Emotion and Symptom-Focused Engagement (EASE)
Description:
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.
Arm group label:
Treatment
Summary:
The goal of this two-site 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:
- Does EASE reduce traumatic stress symptom severity (primary outcome)?
To do so, researchers will compare parents receiving EASE to usual care. 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Self-identified primary parental family caregiver/guardian (i.e., parent assuming
the majority of care activities) of a child: i) 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); ii) <18
years of age; 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
August 1, 2024
Completion date:
October 1, 2028
Lead sponsor:
Agency:
University Health Network, Toronto
Agency class:
Other
Collaborator:
Agency:
The Hospital for Sick Children
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (CIHR)
Agency class:
Other
Source:
University Health Network, Toronto
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06367556
