An interventional study of Usual Care and EASE-psy in Acute Leukemia, sponsored by Canadian Cancer Trials Group. Recruiting at 6 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Canadian Cancer Trials Group · Not applicable, Interventional, and Supportive care
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.
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.
Canadian Cancer Trials Group is the lead sponsor of 93 studies on the registry; 29 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 7 (88%) have results posted.
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Exclusion Criteria:
Other: Usual Care
EASE Intervention = EASE-psy + EASE-phys
Behavioral: EASE-psy
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
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.
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the Stanford Acute Stress Reaction questionnaire (SASRQ)
This 30-item measure assesses severity of traumatic stress symptoms over the past four weeks; it has been updated to be Diagnostic and Statistical Manual of Mental Disorders (DSM-5)-concordant \[American Psychiatric Association 2013\] for acute stress disorder (ASD). Mean severity of traumatic stress symptoms at 4 weeks will be the first primary outcome
Time frame: 4 weeks
Assess the effect of the EASE intervention compared to usual care to reduce physical symptom severity using the Memorial Symptom Assessment Scale (MSAS)
This reliable and valid instrument assesses symptom prevalence, severity and distress associated with 26 common physical and 6 psychological symptoms of cancer. Mean physical symptom severity at 4 weeks will be the second primary outcome
Time frame: 4 weeks
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the SASRQ
Time frame: 8 weeks, 12 weeks & 26 weeks
Assess the effect of the EASE intervention to usual care to reduce physical symptom severity using the MSAS
Time frame: 8 weeks, 12 weeks & 26 weeks
Assess the effect of the EASE intervention compared to usual care on the number of participants meeting criteria consistent with a diagnosis of ASD and threshold ASD based on DSM-5 criteria using the SASRQ
Time frame: 4, 8, 12 and 26 weeks
Assess the effect of the EASE intervention compared to usual care on Quality of Life using The Functional Assessment of chronic Illness Therapy-Spiritual Well-being Scale
Individual subscales of the FACIT-Sp provide scores for physical, social/family, emotional, functional spiritual well-being
Time frame: 4, 8, 12, 26 and 52 weeks
Assess the effect of the EASE intervention compared to usual care on depressive symptoms using The Patient Health Questionnaire-9 (PHQ-9)
This valid 9-item measure of depression has been widely used with patients with advanced cancer. Two additional items assessing intent to cause self-harm and interference with daily activities were included in the measure to ensure patients' safety but are not considered for data analysis.
Time frame: 4, 8 ,12 and 26 weeks
Assess the effect of the EASE intervention compared to usual care on the number of physical symptoms of cancer and the associated symptom-related distress as measured by the (MSAS)
Time frame: 4, 8, 12 & 26 weeks
Assess the effect of the EASE intervention compared to usual care on patient satisfaction with care using the 16-item FAMCAR-P16
Time frame: 4, 8, 12 and 26 weeks
Assess the effect of the EASE intervention compared to usual care on pain using the modified Brief Pain Inventory-Sort Form (BPI)
The BPI is a widely used measure to rapidly assess the severity of pain and its impact on functioning and will be assessed as part of the secondary outcomes
Time frame: 4, 8 12 and 26 weeks
The modified brief Experiences in Close Relationships Scale (ECR-M16) is an instrument to measure attachment security or the ability to rely on close others for support when distressed.
It provides subscale scores assessing attachment anxiety (i.e. fear of abandonment) and attachment avoidance (i.e. defensive independence). The ECR-M16 will only be administered at baseline in both arms of the study.
Time frame: Baseline
10) The EQ-5D-5L will be used to measure generic health status so that it can be used to compute quality-adjusted life years (QALY) in an economic evaluation that compares the benefit and cost of the EASE intervention
Time frame: 4, 8, 12, 26 and 52 weeks
To compare progression-free survival between treatment arms
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2026, 59 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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