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

University Health Network, Toronto

Status: Completed

Conditions: Leukemia, Acute

Treatments: Behavioral: EASE-CG

Study type: Interventional

Funder types: Other

Identifiers

NCT05236296

20-5452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Self-identified primary caregiver (i.e., person assuming the majority of care activities) or co-primary caregiver (i.e., assuming at least 40% of care activities alongside another co-primary caregiver) of an adult or pediatric patient who is newly diagnosed with acute leukemia within 3 months of admission to the Princess Margaret Cancer Centre or the Hospital for Sick Children
• Age ≥18 years
• Fluency in English

Exclusion Criteria: none

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

EASE-CG Intervention

Experimental group

Description:

Participants will be offered one EASE-CG therapy session every week for up to 12 weeks. Each session will last for approximately 30-60 minutes, delivered by a trained therapist at our center. Frequency and/or length of sessions may vary to accommodate the needs and availability of each participant. Outcomes will be assessed at baseline, 1, 3, 6, 9, and 12 months. Participants may be invited to brief, semi-structured interviews.

Treatment:

Behavioral: EASE-CG