Emotion and Symptom-Focused Engagement (EASE) for Caregivers

University Health Network, Toronto306 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

306

Conditions

Trauma and Stressor Related Disorders Pediatric Cancer Caregiver Burden

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The Stanford Acute Stress Reaction Questionnaire [SASRQ]

SASRQ is a 30-item self-report measure with a rating scale of 0-30 (total range 0-150) that assesses the presence and severity of traumatic stress symptoms. Higher scores reflect greater severity.

Time frame: 6-months

Secondary Outcomes

The PTSD Checklist for DSM-5 [PCL-5]

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.

Time frame: 6-months

The SF-36v2 Health Survey

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.

Time frame: 6-months

Patient Health Questionnaire [PHQ-9]

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.

Time frame: 6-months

Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC]

CSE-CSC is a 10-item scale (standardized score 0-100) of to measure the extent of self-efficacy of the caregiver when contributing to patient self-care in the complex care context. Higher scores indicate higher self-efficacy.

Time frame: 6-months

Family Adaptability and Cohesion Evaluation Scales III [FACES-III]

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.

Time frame: 6-months

Clinical Evaluation Questionnaire [CEQ]

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.

Time frame: 6-months

Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10]

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.

Time frame: 6-months

Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts