NCT05236296

Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) Pilot Study

Pilot Study of a Novel Psychotherapeutic Intervention for Caregivers of Patients With Acute Leukemia: Emotion and Symptom-focused Engagement for Caregivers (EASE-CG)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the feasibility and acceptability of an adapted psychosocial intervention, called Emotion and Symptom-focused Engagement for Caregivers (EASE-CG), to reduce traumatic stress symptoms and other psychological distress and increase well-being in primary caregivers of patients newly diagnosed with acute leukemia.

Detailed description

Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) is a brief psychotherapeutic intervention designed for primary caregivers of patients newly diagnosed with acute leukemia (AL). The EASE-CG intervention was adapted from a previous psychotherapeutic intervention for adult patients newly diagnosed with AL, called Emotion and Symptom-focused Engagement (EASE). In a previous pilot trial, EASE was associated with reductions in traumatic stress and physical symptom burden in adult patients with AL. EASE-CG is a sub-study of a multi-center, longitudinal, mixed-methods study on the experience of traumatic stress in primary caregivers of patients newly diagnosed with AL within three months of admission to the hospital (Main study). The purpose of this sub-study is to conduct a non-randomized, mixed-methods pilot study to test the feasibility and acceptability of EASE-CG. A subset of caregivers of pediatric patients from the Main study will be approached to participate in EASE-CG. Quantitative measures will be administered at baseline, 1, 3 (primary endpoint), 6, 9, and 12 months (Main study endpoint). Participants may be invited to brief, semi-structured interviews. The study will take place at the Hospital for Sick Children; the largest leukemia treatment center in Canada for pediatric patients.

Conditions

• Leukemia, Acute

Interventions

Type	Name	Description
BEHAVIORAL	EASE-CG	EASE-CG is an adapted brief psychotherapeutic intervention with relational support and trauma-based cognitive behavioral therapy (CBT) components.

Timeline

• Start date: 2022-04-12
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-02-11
• Last updated: 2025-07-17

Locations

2 sites across 1 country: Canada