Can talk therapy and symptom tracking ease the trauma of leukemia?
NCT ID NCT04224974
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests a program called EASE that combines psychological support with regular symptom checks and early access to palliative care. Researchers want to see if it reduces traumatic stress and physical symptoms in people newly diagnosed with acute leukemia. Half of the 266 participants will get usual care, and half will get usual care plus the EASE program.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Emotion and Symptom-focused Engagement (EASE) intervention combining psychotherapy with symptom screening and palliative care referral
- What this could lead to
- If it works, this could provide a proven way to reduce emotional distress and physical symptoms for people newly diagnosed with acute leukemia.
- What could go wrong
- This is a behavioral intervention trial, not a drug or cure. Results may show only modest benefits, and the intervention requires trained therapists, limiting widespread use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 266 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Juravinski Cancer Centre at Hamilton Health Sciences
RECRUITINGHamilton, Ontario, L8V 5C2, Canada
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Kingston Health Sciences Centre
RECRUITINGKingston, Ontario, K7L 2V7, Canada
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Odette Cancer Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Ottawa Hospital Research Institute
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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Regional Health Authority B, Zone 2
NOT_YET_RECRUITINGSaint John, New Brunswick, E2L 4L2, Canada
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University Health Network
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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