Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia

Official Title

Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia

Summary:

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.

Trial Description

Primary Outcome:

  • Stanford Acute Stress Reaction Questionnaire (SASRQ)
Secondary Outcome:
  • Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)
  • Beck Depression Inventory-II (BDI-II)
  • Brief Pain Inventory short form (BPI-sf)
  • Memorial Symptom Assessment Scale (MSAS)
  • Brief Experiences in Close Relationships Scale (ECR-M16)
  • FAMCARE-P16
  • Clinical Evaluation Questionnaire (CEQ)
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 centre 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society