Emotion and Symptom-Focused Engagement (EASE) for parents of children with cancer

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

This trial will test whether adding the EASE psychotherapy to usual care helps parents of children newly diagnosed or relapsed with cancer have fewer traumatic stress symptoms over six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 306 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Health Network, Toronto (Academic / other)
• Locations: 2 sites (Toronto, Ontario and 1 other locations)
• Trial ID: NCT06367556 on ClinicalTrials.gov

What this trial studies

This Phase III randomized controlled trial compares EASE plus usual care to usual care alone in primary caregivers of children under 18 who have been newly diagnosed or relapsed with life-threatening cancer within the prior six months. Participants complete questionnaires at enrolment and at 4, 8, and 12 weeks and six months, with the primary outcome defined as traumatic stress symptom severity summarized by area under the curve over six months. The trial excludes caregivers with significant cognitive or communication impairment, active suicidal intent, current formal psychotherapy, or whose child is not expected to survive the study period. Optional qualitative interviews will capture caregiver experiences with the intervention.

Who should consider this trial

Good fit: Ideal candidates are English-speaking primary family caregivers aged 18 or older of a child under 18 who was diagnosed or relapsed with a life-threatening cancer within the past six months and is receiving active cancer therapy.

Not a fit: Caregivers with major cognitive or communication impairments, active suicidal intent, those already in formal psychotherapy, or whose child is not expected to survive the study period are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, EASE could reduce traumatic stress symptoms in parents and improve their coping and day-to-day functioning while caring for a child with cancer.

How similar studies have performed: Related emotion-focused and symptom-targeted psychotherapies for caregivers have shown some positive results in prior studies, but EASE is a novel, tailored intervention being tested in a definitive Phase III trial.

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.

Where this trial is running

Toronto, Ontario and 1 other locations

• Princess Margaret Cancer Centre - University Health Network — Toronto, Ontario, Canada (Active_not_recruiting)
• The Hospital for Sick Children — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Dr. Lindsay Jibb, RN, PhD

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