Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia

Recruiting now · Not applicable

Conditions studied: Acute Leukemia

In brief

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.

Key facts

Study ID

NCT04224974

Run by

Canadian Cancer Trials Group

People needed

266

Starts

2022-01-06

Expected to finish

2027-06-30

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada (enrolling)
• Kingston Health Sciences Centre — Kingston, Ontario, Canada (enrolling)
• Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (enrolling)
• Odette Cancer Centre — Toronto, Ontario, Canada (enrolling)
• University Health Network — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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