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

NCT05236296 | Completed

• 1 other identifier: 20-5452
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Leukemia, Acute

Keywords

Caregivers; Psychosocial Intervention; Traumatic Stress; Hematological Malignancies; Supportive Care; Acute Leukemia

Outcome Measures

Primary Outcomes (2)

• Stanford Acute Stress Reaction Questionnaire (SASRQ-II)

  A 30-item reliable, valid, and widely used self-report measure assessing the severity of traumatic stress symptoms over the past four weeks. Total SASRQ scores may range from 0-150, with higher scores indicating increasingly severe traumatic stress symptoms. This measure has been updated to be Diagnostic and Statistical Manual of Mental Disorders (DSM-5)-concordant for acute stress disorder symptoms.

  12 weeks

• PTSD Checklist for DSM-5 (PCL-5)

  A 20-item reliable and valid self-report measure of the presence and severity of post-traumatic stress disorder (PTSD) symptoms over the past month. Total PCL-5 scores may range from 0-80, with higher scores indicating increasingly severe PTSD symptoms. This DSM-5-concordant measure has been included to help validate the DSM-5-concordant version of the SASRQ.

  12 weeks

Secondary Outcomes (6)

• Brief Experiences in Close Relationships Scale (ECR-M16)

  12 weeks

• Patient Health Questionnaire-9 (PHQ-9)

  12 weeks

• Caregiver Reaction Assessment (CRA) Scale

  12 weeks

• Enhancing Recovery In Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI)

  12 weeks

• Family Satisfaction with End-of-Life Care (FAMCARE) Scale

  12 weeks

Study Arms (1)

EASE-CG Intervention

EXPERIMENTAL

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.

Behavioral: EASE-CG

Interventions

EASE-CG BEHAVIORAL

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

EASE-CG Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Hospital for Sick Children: collaborator

Study Sites (2)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (2)

• 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.

  PMID: 31001692 BACKGROUND

• 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.

  PMID: 41161769 DERIVED

MeSH Terms

Conditions

Leukemia; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site

Study Officials

• Gary Rodin, MD FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Lindsay Jibb, RN PhD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All study participants will receive the EASE-CG intervention.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 11, 2022
• Study Start: April 12, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CA (2)