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

NCT ID: NCT04224974

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-06
• Study Completion Date: 2027-06-30

Brief 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.

Detailed Description

The standard or usual care treatment for patients with newly diagnosed acute leukemia involves admission to hospital for treatment (e.g. induction chemotherapy). Additional support services may be delivered if requested or if a doctor thinks it is necessary.

Little research has been done looking at the psychological and physical consequences of being diagnosed with and treated for acute leukemia, but our research team has found that a significant number of these individuals experience symptoms of traumatic stress and severe physical symptoms. Even less research has been done looking at ways to help alleviate this psychological and physical distress. Emotion and Symptom-focused Engagement (EASE) is an integrated psychosocial and early palliative care (symptom control) intervention designed to reduce psychological distress and physical symptom burden in patients newly diagnosed with acute leukemia. The EASE intervention provides i) tailored supportive psychotherapy (called EASE-psy) during the initial weeks of treatment to reduce symptoms of traumatic stress, and ii) symptom screening during the initial inpatient treatment period with triggered referral to early palliative care (symptom control) to help manage moderate to severe physical symptoms (called EASE-phys).

A phase II trial of EASE in patients with newly diagnosed acute leukemia demonstrated feasibility and preliminary evidence that it reduces psychological distress and physical symptom severity compared to usual care. This new trial is a definitive phase III, multi-site randomized controlled trial to test the effectiveness of EASE at reducing psychological distress and physical burden.

Conditions

Acute Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Other: Usual Care

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: OTHER

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: Usual Care + EASE Intervention-psy

EASE Intervention = EASE-psy + EASE-phys

Group Type: EXPERIMENTAL

EASE-psy

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Cancer Society (CCS)

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Princess Margaret Hospital, University Health Network

UNKNOWN

Sponsor Role: collaborator

Canadian Cancer Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gary Rodin

Role: STUDY_CHAIR

Princess Margaret Hospital, University Health Network

Camilla Zimmerman

Role: STUDY_CHAIR

Princess Margaret Hospital, University Health Network

Locations

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status: RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status: RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Site Status: RECRUITING

Odette Cancer Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

University Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Harriet Richardson

Role: CONTACT

hrichardson@ctg.queensu.ca

613-533-6430

Lois Shepherd

Role: CONTACT

lshepherd@ctg.queensu.ca

613-533-6430

Facility Contacts

Alejandro Garcia-Horton

Role: primary

Annette Hay

Role: primary

613 533-6430 ext. 77094

Pierre Villeneuve

Role: primary

613

Lee Mozessohn

Role: primary

416 480-5000 ext. 5847

Gary Rodin

Role: primary

416 946-4504

Other Identifiers

SC26

Identifier Type: -

Identifier Source: org_study_id