Emotion and Symptom-Focused Engagement (EASE) for Caregivers

NCT06367556 | Recruiting

• 1 other identifier: 4542
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 2

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.

Conditions

Trauma and Stressor Related Disorders; Caregiver Burden; Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6-months

Secondary Outcomes (7)

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

  6-months

• The SF-36v2 Health Survey

  6-months

• Patient Health Questionnaire [PHQ-9]

  6-months

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

  6-months

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

  6-months

Other Outcomes (4)

• Caregiver Reaction Assessment Scale [CRA]

  6-months

• ENRICHD Social Support Instrument [ESSI]

  6-months

• Experiences in Close Relationships Scale [ECR-16]

  6-months

Study Arms (2)

Treatment

EXPERIMENTAL

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.

Behavioral: Emotion and Symptom-Focused Engagement (EASE)

Usual Care

NO INTERVENTION

Participants randomized to the control group will receive usual care.

Interventions

Emotion and Symptom-Focused Engagement (EASE) BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Hospital for Sick Children: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (2)

Princess Margaret Cancer Centre - University Health Network

Toronto, Ontario, Canada

ACTIVE NOT RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Trauma and Stressor Related Disorders; Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Dr. Lindsay Jibb, RN, PhD

CONTACT

416-813-7654; lindsay.jibb@sickkids.ca

Elham Hashemi, MA

CONTACT

416-813-7654; elham.hashemi@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 16, 2024
• Study Start: February 14, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)