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

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.

Interventions

• 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.

Primary outcome measures

• The Stanford Acute Stress Reaction Questionnaire [SASRQ] [Time frame: 6-months]

Secondary outcome measures (7)

• The PTSD Checklist for DSM-5 [PCL-5] [Time frame: 6-months]
• The SF-36v2 Health Survey [Time frame: 6-months]
• Patient Health Questionnaire [PHQ-9] [Time frame: 6-months]
• Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC] [Time frame: 6-months]
• Family Adaptability and Cohesion Evaluation Scales III [FACES-III] [Time frame: 6-months]
• Clinical Evaluation Questionnaire [CEQ] [Time frame: 6-months]
• Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10] [Time frame: 6-months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Canada · 2 centers

• Princess Margaret Cancer Centre - University Health Network — Toronto
• The Hospital for Sick Children — Toronto

Identifiers

NCT: NCT06367556 · 4542

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗