Clinical trial · Interventional
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)
NCT05236296CI-TRIAL-00092301EASE-CGcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EASE-CG | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EASE-CG Intervention
- 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.
- interventionNames
- Behavioral: EASE-CG
Primary outcomes (2)
- measure
- Stanford Acute Stress Reaction Questionnaire (SASRQ-II)
- timeFrame
- 12 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDRodin 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
- DERIVEDJibb 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