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

Titre officiel

Pilot Study of a Novel Psychotherapeutic Intervention for Caregivers of Patients With Acute Leukemia: Emotion and Symptom-focused Engagement for Caregivers (EASE-CG)

Sommaire:

L’objectif de cette étude est d’évaluer la faisabilité et l’acceptabilité d’une intervention psychosociale adaptée, appelée Engagement centré sur les émotions et les symptômes pour les soignants (en anglais Emotion and Symptom-focused Engagement for Caregivers [EASE]), afin de réduire les symptômes de stress traumatique et autre détresse psychologique et d’accroître le bien-être des soignants principaux de patients auxquels une leucémie aiguë a récemment été diagnostiquée.

Description de l'essai

Primary Outcome:

• Stanford Acute Stress Reaction Questionnaire (SASRQ)
• PTSD Checklist for DSM-5 (PCL-5)

Secondary Outcome:

• Brief Experiences in Close Relationships Scale (ECR-M16)
• Patient Health Questionnaire-9 (PHQ-9)
• Caregiver Reaction Assessment (CRA) Scale
• ENRICHD Social Support Instrument (ESSI)
• Family Satisfaction with End-of-Life Care (FAMCARE) Scale
• Traditional Masculinity-Femininity (TMF) Scale

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-centre, 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 centre in Canada for pediatric patients.

Voir cet essai sur ClinicalTrials.gov