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

NCT ID: NCT05236296

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2024-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

EASE-CG Intervention

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.

Group Type: EXPERIMENTAL

EASE-CG

Intervention Type: BEHAVIORAL

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

Interventions

EASE-CG

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Rodin, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Lindsay Jibb, RN PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

References

Rodin G, Malfitano C, Rydall A, Schimmer A, Marmar CM, Mah K, Lo C, Nissim R, Zimmermann C. Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia. Support Care Cancer. 2020 Jan;28(1):163-176. doi: 10.1007/s00520-019-04723-2. Epub 2019 Apr 17.

Reference Type: BACKGROUND

PMID: 31001692 (View on PubMed)

Jibb LA, Yu A, Nanos S, Malfitano C, Foran L, Hunt K, Malakian A, Zimmermann C, Schultebraucks K, Pham NA, Rydall A, Alexander S, Rodin G. The Emotion and Symptom-Focused Engagement (EASE) Psychotherapeutic Intervention for Parents of Children With Acute Leukemia: A Feasibility Trial. Psychooncology. 2025 Nov;34(11):e70310. doi: 10.1002/pon.70310.

Reference Type: DERIVED

PMID: 41161769 (View on PubMed)

Other Identifiers

20-5452

Identifier Type: -

Identifier Source: org_study_id