A program to support emotional and physical health in patients with acute leukemia
Official title: Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia
Run by Canadian Cancer Trials Group · NCT04224974 · Data updated 2026-11-12
This study tests if a new support program that includes therapy and symptom checks can help people newly diagnosed with acute leukemia feel better emotionally and physically compared to standard care alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 196 (estimated) |
| Sponsor | Canadian Cancer Trials Group Research network |
| Drugs / interventions | chemotherapy |
| Locations | 6 sites (Saint John, New Brunswick and 5 other locations) |
| Status | Recruiting |
| Started | January 6, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT04224974 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have been newly diagnosed with acute leukemia and are about to begin induction therapy.
✕Probably not a fit
Patients who are not fluent in English or those who do not meet the cognitive screening criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of a novel intervention called Emotion and Symptom-focused Engagement (EASE) for individuals newly diagnosed with acute leukemia. Participants will be divided into two groups: one receiving standard care and the other receiving standard care plus the EASE intervention, which includes tailored psychotherapy and symptom screening with referrals to palliative care. The aim is to reduce psychological distress and physical symptom burden during the initial treatment phase. The study builds on preliminary findings suggesting that EASE may improve patient outcomes compared to usual care.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the emotional and physical well-being of patients newly diagnosed with acute leukemia.
How similar studies have gone: Previous studies have shown preliminary success with similar psychosocial interventions in cancer care, indicating potential for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada Recruiting -
Kingston Health Sciences Centre
Kingston, Ontario, Canada Recruiting -
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada Recruiting -
Odette Cancer Centre
Toronto, Ontario, Canada Recruiting -
University Health Network
Toronto, Ontario, Canada Recruiting -
Regional Health Authority B, Zone 2
Saint John, New Brunswick, Canada Not yet recruiting
Study contacts
- Study coordinator: Harriet Richardson
- Email: hrichardson@ctg.queensu.ca
- Phone: 613-533-6430
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.