Pilot Study of a Novel Psychotherapeutic Intervention for Caregivers of Patients With Acute Leukemia: Emotion and Symptom-focused Engagement for Caregivers (EASE-CG)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Leukemia, Acute
- Sponsor
- University Health Network, Toronto
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Stanford Acute Stress Reaction Questionnaire (SASRQ-II)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Stanford Acute Stress Reaction Questionnaire (SASRQ-II)
Time Frame: 12 weeks
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.
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: 12 weeks
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.
Secondary Outcomes
- Patient Health Questionnaire-9 (PHQ-9)(12 weeks)
- Enhancing Recovery In Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI)(12 weeks)
- Traditional Masculinity-Femininity (TMF) Scale(Baseline)
- Brief Experiences in Close Relationships Scale (ECR-M16)(12 weeks)
- Caregiver Reaction Assessment (CRA) Scale(12 weeks)
- Family Satisfaction with End-of-Life Care (FAMCARE) Scale(12 weeks)