Acute Leukemia Clinical Trial
Official title:
Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia
The purpose of this study is to test the feasibility of an individual psychological and physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia.
This study involves the pilot-testing of a newly developed, brief manualized individual
psychotherapy and physical symptom control intervention, called Emotion And Symptom-focused
Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals
newly diagnosed with acute leukemia. The purpose of this study is to conduct a two-arm
randomized pilot trial (RPT) to test the feasibility, acceptability, and preliminary efficacy
of EASE against usual care (UC) for the reduction of traumatic stress and physical symptom
burden in patients with acute leukemia. Usual care for individuals with acute leukemia
treated at the Princess Margaret Cancer Centre includes referral for non-standardized, and
primarily instrumental, psychosocial care and palliative care service as needed.
The design will be an unblinded RPT consisting of two conditions (EASE and UC), with a
baseline assessment and follow-ups at 4, 8, and 12 weeks. The trial will take place at the
Princess Margaret Cancer Centre, University Health Network; a comprehensive cancer center in
Toronto, Canada. Participants will be newly diagnosed with acute leukemia, within one month
of diagnosis and/or admission to hospital for treatment with curative intent.
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