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Emotion and Symptom-Focused Engagement (EASE) for Acute Leukemia (EASE Trial)

N/A
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years.
Newly diagnosed AL (acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL)) and is recruited within 2 weeks of hospital admission. For patients diagnosed with a mixed phenotype AL, the dominant sub-type must be identified for stratification purposes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

EASE Trial Summary

This trial is testing a new intervention called EASE to see if it can help people with leukemia feel better emotionally and physically.

Who is the study for?
This trial is for adults over 18 who've been newly diagnosed with acute leukemia (AML or ALL) and are within two weeks of hospital admission. They must pass a cognitive test, plan to receive induction chemotherapy, speak English fluently, and be able to complete questionnaires. Excluded are those already receiving palliative care or psychological counseling in the hospital, diagnosed with certain types of leukemia, or have major communication issues.Check my eligibility
What is being tested?
The study tests if a new intervention called EASE—combining psychological support with symptom screening and early palliative care referrals—can reduce distress and symptoms in acute leukemia patients compared to usual care alone. Participants will be randomly divided into two groups: one receives standard treatment; the other gets standard plus EASE.See study design
What are the potential side effects?
Since EASE is a psychological support intervention combined with symptom management rather than a drug, it may not have typical 'side effects.' However, participants might experience emotional discomfort when discussing their illness during sessions.

EASE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I was recently diagnosed with acute leukemia and admitted to the hospital within the last 2 weeks.
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I can pass a basic memory and concentration test or have an exception due to special circumstances.
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I am currently undergoing or about to start chemotherapy aimed at curing my cancer.
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I can and will complete English questionnaires.

EASE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess the effect of the EASE intervention compared to usual care to reduce physical symptom severity using the Memorial Symptom Assessment Scale (MSAS)
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the Stanford Acute Stress Reaction questionnaire (SASRQ)
Secondary outcome measures
10) The EQ-5D-5L will be used to measure generic health status so that it can be used to compute quality-adjusted life years (QALY) in an economic evaluation that compares the benefit and cost of the EASE intervention
Assess the effect of the EASE intervention compared to usual care on Quality of Life using The Functional Assessment of chronic Illness Therapy-Spiritual Well-being Scale
Assess the effect of the EASE intervention compared to usual care on depressive symptoms using The Patient Health Questionnaire-9 (PHQ-9)
+8 more

EASE Trial Design

2Treatment groups
Experimental Treatment
Group I: Other: Usual CareExperimental Treatment1 Intervention
Group II: Behavioral: Usual Care + EASE Intervention-psyExperimental Treatment1 Intervention
EASE Intervention = EASE-psy + EASE-phys

Find a Location

Who is running the clinical trial?

Canadian Cancer Society (CCS)OTHER
78 Previous Clinical Trials
37,479 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,336 Previous Clinical Trials
25,750,842 Total Patients Enrolled
Princess Margaret Hospital, University Health NetworkUNKNOWN

Media Library

EASE-psy Clinical Trial Eligibility Overview. Trial Name: NCT04224974 — N/A
Acute Leukemia Research Study Groups: Other: Usual Care, Behavioral: Usual Care + EASE Intervention-psy
Acute Leukemia Clinical Trial 2023: EASE-psy Highlights & Side Effects. Trial Name: NCT04224974 — N/A
EASE-psy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04224974 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaged in this clinical experiment?

"Correct. The information that can be found on clinicaltrials.gov demonstrates that the recruitment of participants is still in progress for this trial, which was first posted on December 23rd 2019 and most recently updated on October 28th 2022. As such, 266 individuals need to be recruited from 3 distinct medical centres."

Answered by AI

Is there still room for additional participants in this clinical investigation?

"Affirmative. As per clinicaltrials.gov, this research study is actively seeking candidates for enrollment and has been since December 23rd 2019. 266 individuals need to be recruited from 3 different clinics before the trial ends on October 28th 2022."

Answered by AI
~84 spots leftby Mar 2025