NCT02353559

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
BEHAVIORAL	EASE	EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-02-02
• Last updated: 2019-09-27

Locations

1 site across 1 country: Canada