RecruitingNot ApplicableNCT04224974

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

Sponsor

Canadian Cancer Trials Group

Enrollment

266 participants

Start Date

Jan 6, 2022

Study Type

INTERVENTIONAL

Conditions

Acute Leukemia

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study offers emotional and psychological support to patients newly diagnosed with acute leukemia (a fast-moving blood cancer) who are about to start intensive chemotherapy. It tests whether an engagement program can improve emotional well-being during treatment. **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with acute leukemia (AML, ALL, or related types) - You are about to receive induction chemotherapy with the goal of achieving remission - You can speak and read English - You pass a brief mental clarity test (showing you can follow instructions) - You are being recruited within the first two weeks of hospital admission **You may NOT be eligible if...** - You have serious communication difficulties (severe hearing loss or speech impairment) - You are already receiving in-hospital psychological or psychiatric counseling - You are receiving palliative care only - You are unable to complete the required questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUsual 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

BEHAVIORALEASE-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.