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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Hospital for Sick Children
  Toronto, Ontario, Canada Recruiting
• Princess Margaret Cancer Centre - University Health Network
  Toronto, Ontario, Canada Active not recruiting

Study contacts

• Study coordinator: Dr. Lindsay Jibb, RN, PhD
• Email: lindsay.jibb@sickkids.ca
• Phone: 416-813-7654

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.