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

NCT04224974 | Recruiting DMC

• 1 other identifier: SC26
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Leukemia

Outcome Measures

Primary Outcomes (2)

• Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the Stanford Acute Stress Reaction questionnaire (SASRQ)

  This 30-item measure assesses severity of traumatic stress symptoms over the past four weeks; it has been updated to be Diagnostic and Statistical Manual of Mental Disorders (DSM-5)-concordant \[American Psychiatric Association 2013\] for acute stress disorder (ASD). Mean severity of traumatic stress symptoms at 4 weeks will be the first primary outcome

  4 weeks

• Assess the effect of the EASE intervention compared to usual care to reduce physical symptom severity using the Memorial Symptom Assessment Scale (MSAS)

  This reliable and valid instrument assesses symptom prevalence, severity and distress associated with 26 common physical and 6 psychological symptoms of cancer. Mean physical symptom severity at 4 weeks will be the second primary outcome

  4 weeks

Secondary Outcomes (11)

• Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the SASRQ

  8 weeks, 12 weeks & 26 weeks

• Assess the effect of the EASE intervention to usual care to reduce physical symptom severity using the MSAS

  8 weeks, 12 weeks & 26 weeks

• Assess the effect of the EASE intervention compared to usual care on the number of participants meeting criteria consistent with a diagnosis of ASD and threshold ASD based on DSM-5 criteria using the SASRQ

  4, 8, 12 and 26 weeks

• 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

  4, 8, 12, 26 and 52 weeks

• Assess the effect of the EASE intervention compared to usual care on depressive symptoms using The Patient Health Questionnaire-9 (PHQ-9)

  4, 8 ,12 and 26 weeks

Study Arms (2)

Other: Usual Care

EXPERIMENTAL

Other: Usual Care

Behavioral: Usual Care + EASE Intervention-psy

EXPERIMENTAL

EASE Intervention = EASE-psy + EASE-phys

Behavioral: EASE-psy

Interventions

Usual Care 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

Other: Usual Care

EASE-psy 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.

Behavioral: Usual Care + EASE Intervention-psy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Canadian Cancer Society (CCS): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Princess Margaret Hospital, University Health Network: collaborator

Study Sites (5)

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Study Officials

• Gary Rodin

  Princess Margaret Hospital, University Health Network

  STUDY CHAIR

• Camilla Zimmerman

  Princess Margaret Hospital, University Health Network

  STUDY CHAIR

Central Study Contacts

Harriet Richardson

CONTACT

613-533-6430; hrichardson@ctg.queensu.ca

Lois Shepherd

CONTACT

613-533-6430; lshepherd@ctg.queensu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 13, 2020
• Study Start: January 6, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)