NCT04224974

Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia

Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out whether a novel manualized intervention, called Emotion and Symptom-focused Engagement (EASE), that combines psychological support with symptom screening plus triggered referral to early palliative care for symptom control, reduces psychological distress and physical symptom burden in individuals newly diagnosed with acute leukemia. To do this, half of the participants in this study will receive the usual care offered to patients with acute leukemia and half of the participants will receive usual care plus the EASE intervention.

Detailed description

The standard or usual care treatment for patients with newly diagnosed acute leukemia involves admission to hospital for treatment (e.g. induction chemotherapy). Additional support services may be delivered if requested or if a doctor thinks it is necessary. Little research has been done looking at the psychological and physical consequences of being diagnosed with and treated for acute leukemia, but our research team has found that a significant number of these individuals experience symptoms of traumatic stress and severe physical symptoms. Even less research has been done looking at ways to help alleviate this psychological and physical distress. Emotion and Symptom-focused Engagement (EASE) is an integrated psychosocial and early palliative care (symptom control) intervention designed to reduce psychological distress and physical symptom burden in patients newly diagnosed with acute leukemia. The EASE intervention provides i) tailored supportive psychotherapy (called EASE-psy) during the initial weeks of treatment to reduce symptoms of traumatic stress, and ii) symptom screening during the initial inpatient treatment period with triggered referral to early palliative care (symptom control) to help manage moderate to severe physical symptoms (called EASE-phys). A phase II trial of EASE in patients with newly diagnosed acute leukemia demonstrated feasibility and preliminary evidence that it reduces psychological distress and physical symptom severity compared to usual care. This new trial is a definitive phase III, multi-site randomized controlled trial to test the effectiveness of EASE at reducing psychological distress and physical burden.

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
OTHER	Usual Care	The usual care group will receive usual care of their acute leukemia at their centre but no formal psychological or palliative care intervention as part of this trial
BEHAVIORAL	EASE-psy	All patients randomized to EASE will receive tailored supportive psychotherapy over the initial 8 weeks following the diagnosis of acute leukemia. The psychotherapy will be delivered by trained therapists and combines elements of relational support, affect regulation, and trauma-informed cognitive behavioural therapy (CBT). -EASE-phys: All patients randomized to EASE will receive weekly symptom screening during the initial inpatient treatment period (typically 4 weeks) with triggered referral to early palliative care (symptom control) to help manage moderate to severe physical symptoms based on a philosophy of multidisciplinary care and comprehensive assessment of symptoms.

Timeline

• Start date: 2022-01-06
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2020-01-13
• Last updated: 2026-03-27

Locations

5 sites across 1 country: Canada