Clinical trial NCT05236296: Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) Pilot Study
Official title: Pilot Study of a Novel Psychotherapeutic Intervention for Caregivers of Patients With Acute Leukemia: Emotion and Symptom-focused Engagement for Caregivers (EASE-CG)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia, Acute
Keywords: Caregivers
Psychosocial Intervention
Traumatic Stress
Hematological Malignancies
Supportive Care
Acute Leukemia
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2022-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All study participants will receive the EASE-CG intervention.
Primary purpose: SUPPORTIVE_CARE

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.

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: none

Primary outcomes:
measure: Stanford Acute Stress Reaction Questionnaire (SASRQ-II)
timeFrame: 12 weeks
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: 12 weeks
Secondary outcomes:
measure: Brief Experiences in Close Relationships Scale (ECR-M16)
timeFrame: 12 weeks
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 weeks
measure: Caregiver Reaction Assessment (CRA) Scale
timeFrame: 12 weeks
measure: Enhancing Recovery In Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI)
timeFrame: 12 weeks
measure: Family Satisfaction with End-of-Life Care (FAMCARE) Scale
timeFrame: 12 weeks
measure: Traditional Masculinity-Femininity (TMF) Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Gary Rodin, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Lindsay Jibb, RN PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.