Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• The Stanford Acute Stress Reaction Questionnaire [SASRQ] — 6-months
  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.

Trial sites (2)

More University Health Network, Toronto trials in Canada

Other trials for the same condition