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
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Newly diagnosed AL (acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL) chronic myelogenous leukemia (CML) in blast crisis; T-cell leukemia lymphoma (TLL), and AL of ambiguous lineage) and is recruited up to 1 week prior to hospital admission or within 2 weeks of hospital admission. For patients diagnosed with a mixed phenotype AL, the dominant sub-type must be identified for stratification purposes.
* Receiving or expected to receive induction therapy with curative intent at the time of recruitment.
* Age ≥ 18 years.
* Ability to pass the cognitive screening test at the time of recruitment (Short Orientation-Memory-Concentration Test (SOMC) score ≥ 20), unless deemed suitable at the CRA's discretion (e.g. in extenuating circumstances such as interruptions during the administration of the measure or when patients report a learning disability that can influence the results).
* Patient is fluent in English and is able (i.e. sufficiently literate and competent) and willing to complete the baseline questionnaires in English. Ability but unwillingness to complete the baseline questionnaires will make the patient ineligible.
Exclusion Criteria:
* Major communication difficulties at the time of recruitment, as assessed by the research team (e.g. severe hearing impairment or inability to speak).
* Receiving on-site (in hospital) psychological/psychiatric counseling at the time of recruitment.
* Receiving on-site (in hospital) palliative care services at the time of recruitment.
* A diagnosis of acute promyelocytic leukemia.
Primary outcome measure(s)
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the Stanford Acute Stress Reaction questionnaire (SASRQ) — 4 weeks 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
Assess the effect of the EASE intervention compared to usual care to reduce physical symptom severity using the Memorial Symptom Assessment Scale (MSAS) — 4 weeks 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
Trial sites (6)
Facility
City
Region
Status
Regional Health Authority B, Zone 2
Saint John
New Brunswick
Not Yet Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton
Ontario
Recruiting
Kingston Health Sciences Centre
Kingston
Ontario
Recruiting
Ottawa Hospital Research Institute
Ottawa
Ontario
Recruiting
Odette Cancer Centre
Toronto
Ontario
Recruiting
University Health Network
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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