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

NCT04224974 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-03-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Usual Care

The usual care group will receive usual care of their acute leukemia at their centre but no formal psychological or palliative care intervention as part of this trial

BEHAVIORAL

EASE-psy

All patients randomized to EASE will receive tailored supportive psychotherapy over the initial 8 weeks following the diagnosis of acute leukemia. The psychotherapy will be delivered by trained therapists and combines elements of relational support, affect regulation, and trauma-informed cognitive behavioural therapy (CBT). -EASE-phys: All patients randomized to EASE will receive weekly symptom screening during the initial inpatient treatment period (typically 4 weeks) with triggered referral to early palliative care (symptom control) to help manage moderate to severe physical symptoms based on a philosophy of multidisciplinary care and comprehensive assessment of symptoms.

Sponsors & Collaborators

  • Canadian Cancer Society (CCS)

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Princess Margaret Hospital, University Health Network

    collaborator UNKNOWN

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Gary Rodin · Princess Margaret Hospital, University Health Network

  • Camilla Zimmerman · Princess Margaret Hospital, University Health Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2026-12-31
Completion
2027-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04224974 on ClinicalTrials.gov