Clinical trial NCT06367556: Emotion and Symptom-Focused Engagement (EASE) for Caregivers
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma and Stressor Related Disorders
Pediatric Cancer
Caregiver Burden
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-04-16
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


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 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.

Primary outcomes:
measure: The Stanford Acute Stress Reaction Questionnaire [SASRQ]
timeFrame: 6-months
Secondary outcomes:
measure: The PTSD Checklist for DSM-5 [PCL-5]
timeFrame: 6-months
measure: The SF-36v2 Health Survey
timeFrame: 6-months
measure: Patient Health Questionnaire [PHQ-9]
timeFrame: 6-months
measure: Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC]
timeFrame: 6-months
measure: Family Adaptability and Cohesion Evaluation Scales III [FACES-III]
timeFrame: 6-months
measure: Clinical Evaluation Questionnaire [CEQ]
timeFrame: 6-months
measure: Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10]
timeFrame: 6-months
Other outcomes:
measure: Caregiver Reaction Assessment Scale [CRA]
timeFrame: 6-months
measure: ENRICHD Social Support Instrument [ESSI]
timeFrame: 6-months
measure: Experiences in Close Relationships Scale [ECR-16]
timeFrame: 6-months
measure: Hope of Improvement subscale of the Therapy Expectation and Evaluation Scale [PATHEVH]
timeFrame: Baseline
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre - University Health Network
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References: