Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia
Acute LeukemiaThe 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.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
18 and up
Participation 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.
Study Location
Odette Cancer Centre
Odette Cancer CentreToronto, Ontario
Canada
Contact Study Team
Lee Mozessohn
416 480-5000Ottawa Hospital Research Institute
Ottawa Hospital Research InstituteOttawa, Ontario
Canada
Contact Study Team
Pierre Villeneuve
613Juravinski Cancer Centre at Hamilton Health Sciences
Juravinski Cancer Centre at Hamilton Health SciencesHamilton, Ontario
Canada
Contact Study Team
Alejandro Garcia-Horton
University Health Network
University Health NetworkToronto, Ontario
Canada
Contact Study Team
Gary Rodin
416 946-4504Kingston Health Sciences Centre
Kingston Health Sciences CentreKingston, Ontario
Canada
Contact Study Team
Annette Hay
613 533-6430- Study Sponsored By
- Canadian Cancer Trials Group
- Participants Required
- More Information
- Study ID:
NCT04224974