Emotion and Symptom-Focused Engagement (EASE) for Caregivers

University Health Network, Toronto

Status: Enrolling

Conditions: Caregiver Burden; Trauma and Stressor Related Disorders; Pediatric Cancer

Treatments: Behavioral: Emotion and Symptom-Focused Engagement (EASE)

Study type: Interventional

Funder types: Other

Identifiers

NCT06367556

4542

Details and patient eligibility

About

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.

Enrollment: 306 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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306 participants in 2 patient groups

Treatment

Experimental group

Description:

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.

Treatment:

Behavioral: Emotion and Symptom-Focused Engagement (EASE)

Usual Care

No Intervention group

Description:

Participants randomized to the control group will receive usual care.