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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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 criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Usual Care
  • EASE-psy

Treatment groups

266 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Canadian Cancer Trials Group

Lead sponsor

Canadian Cancer Society (CCS)

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Princess Margaret Hospital, Canada

Collaborator