Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Not Applicable

Not yet recruiting

• Conditions: Trauma and Stressor Related Disorders; Pediatric Cancer; Caregiver Burden
• Interventions: Behavioral: Emotion and Symptom-Focused Engagement (EASE)

• Registration Number: NCT06367556
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-15
• Study First Posted: 2024-04-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Study Start: 2024-08-01
• Primary Completion: 2027-10-01
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 306

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Emotion and Symptom-Focused Engagement (EASE)	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.

Primary Outcome Measures

Name	Time	Method
The PTSD Checklist for DSM-5 [PCL-5]	6-months	PCL-5 is a 20-item self-report measure with a rating scale of 0-4 (total range 0-80) that assesses the presence and severity of traumatic stress symptoms. Higher scores reflect greater severity.

Secondary Outcome Measures

Name	Time	Method
Caregiving Health Engagement Scale [CHE-s]	6-months	CHE-s is a 7-item scale to assess a caregiver's psychological attitude towards caring for their child. Items allow caregivers to position themselves in the state that mostly describes their current experience: denial, hyper-activation, drowning, and balance.
Family Adaptability and Cohesion Evaluation Scales III [FACES-III]	6-months	FACES-III is a 20-item measure with a rating scale of 1-5 that will be used to assess parent perceived family functioning. 10-items measure family cohesion and 10-items measure adaptability (range 10-50, respectively), with higher scores for each domain indicating greater connectivity or flexibility compared to disengagement or rigidity.
Clinical Evaluation Questionnaire [CEQ]	6-months	CEQ is a 7-item patient-reported experience measure with a rating scale of 0-4 that will assess the perceived benefits that caregivers experience in their interactions with healthcare providers in domains relevant to advanced cancer. A total score is calculated by summing the item scores where higher scores reflect greater perceived benefit.
Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10]	6-months	FAMCARE-10 was developed to measure family caregiver satisfaction with the care of patients with advanced cancer with a rating scale of 0 (dissatisfied) to 2 (satisfied) where higher total scores reflect greater satisfaction.
The SF-36v2 Health Survey	6-months	SF-36v2 consists of eight scales yielding two summary measures: physical and mental health. It can be scored using both norm-based scoring (NBS) algorithms and the original 0-100 scoring system, where higher scores indicate better health status.
Patient Health Questionnaire [PHQ-9]	6-months	PHQ-9 is a 9-item measure with a rating scale of 0-3 (total range 0-27) that assesses the presence and severity of depressive symptoms. Higher scores reflect greater depression severity.