Acute LeukemiaEASENCT04224974
Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia
A study testing EASE-psy in people with Acute Leukemia, run by Canadian Cancer Trials Group at 6 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- EASE-psy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 6 sitesCanada
- Study dates
- 6 Jan 2022to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Canada6 sites, 6 recruiting
- Recruiting
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
Alejandro Garcia-Horton
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Annette Hay, 613 533-6430 ext. 77094
- Recruiting
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
Pierre Villeneuve, 613
- Not yet recruiting
Regional Health Authority B, Zone 2
Saint John, New Brunswick, E2L 4L2
Alfonso Rivera Duarte, 506 648-7109
- Recruiting
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
Lee Mozessohn, 416 480-5000 ext. 5847
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Gary Rodin, 416 946-4504
About this study
Official title: Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia
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.
Read the 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
- Being tested
- Usual Care, EASE-psy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
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
EASE-psyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Other: Usual Care | Experimental | Not described Receives: Other: Usual Care |
| Behavioral: Usual Care + EASE Intervention-psy | Experimental | EASE Intervention = EASE-psy + EASE-phys Receives: Behavioral: EASE-psy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (12)
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
Measured: 4 weeks
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the SASRQ
Measured: 8 weeks, 12 weeks & 26 weeks
Assess the effect of the EASE intervention to usual care to reduce physical symptom severity using the MSAS
Measured: 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
Measured: 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
Individual subscales of the FACIT-Sp provide scores for physical, social/family, emotional, functional spiritual well-being
Measured: 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)
This valid 9-item measure of depression has been widely used with patients with advanced cancer. Two additional items assessing intent to cause self-harm and interference with daily activities were included in the measure to ensure patients' safety but are not considered for data analysis.
Measured: 4, 8 ,12 and 26 weeks
Assess the effect of the EASE intervention compared to usual care on the number of physical symptoms of cancer and the associated symptom-related distress as measured by the (MSAS)
Measured: 4, 8, 12 & 26 weeks
Assess the effect of the EASE intervention compared to usual care on patient satisfaction with care using the 16-item FAMCAR-P16
Measured: 4, 8, 12 and 26 weeks
Assess the effect of the EASE intervention compared to usual care on pain using the modified Brief Pain Inventory-Sort Form (BPI)
The BPI is a widely used measure to rapidly assess the severity of pain and its impact on functioning and will be assessed as part of the secondary outcomes
Measured: 4, 8 12 and 26 weeks
The modified brief Experiences in Close Relationships Scale (ECR-M16) is an instrument to measure attachment security or the ability to rely on close others for support when distressed.
It provides subscale scores assessing attachment anxiety (i.e. fear of abandonment) and attachment avoidance (i.e. defensive independence). The ECR-M16 will only be administered at baseline in both arms of the study.
Measured: Baseline
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
Measured: 4, 8, 12, 26 and 52 weeks
To compare progression-free survival between treatment arms
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start6 Jan 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Gary Rodin, Study chair, Princess Margaret Hospital, CanadaCamilla Zimmerman, Study chair, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224974
- Sponsor's protocol ID
- SC26
- Acronym
- EASE
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2019
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia
- ClinicalTrials.gov ID
- NCT04224974
- Acronym / sponsor ID
- EASE / SC26
- Conditions
- Acute Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Canadian Cancer Society (CCS), Canadian Institutes of Health Research (CIHR), Princess Margaret Hospital, Canada
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Other: Usual Care | Experimental | Other: Usual Care |
| Behavioral: Usual Care + EASE Intervention-psy | Experimental | Behavioral: EASE-psyEASE Intervention = EASE-psy + EASE-phys |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareThe 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 | Other: Usual Care |
| EASE-psyAll 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. | Behavioural | Behavioral: Usual Care + EASE Intervention-psy |
Primary outcome
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the Stanford Acute Stress Reaction questionnaire (SASRQ)
Time frame: 4 weeks
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
12 secondary outcomes
Assess the effect of the EASE intervention compared to usual care to reduce physical symptom severity using the Memorial Symptom Assessment Scale (MSAS)
Time frame: 4 weeks
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the SASRQ
Time frame: 8 weeks, 12 weeks & 26 weeks
Assess the effect of the EASE intervention to usual care to reduce physical symptom severity using the MSAS
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 4, 8 ,12 and 26 weeks
Assess the effect of the EASE intervention compared to usual care on the number of physical symptoms of cancer and the associated symptom-related distress as measured by the (MSAS)
Time frame: 4, 8, 12 & 26 weeks
Assess the effect of the EASE intervention compared to usual care on patient satisfaction with care using the 16-item FAMCAR-P16
Time frame: 4, 8, 12 and 26 weeks
Assess the effect of the EASE intervention compared to usual care on pain using the modified Brief Pain Inventory-Sort Form (BPI)
Time frame: 4, 8 12 and 26 weeks
The modified brief Experiences in Close Relationships Scale (ECR-M16) is an instrument to measure attachment security or the ability to rely on close others for support when distressed.
Time frame: Baseline
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
Time frame: 4, 8, 12, 26 and 52 weeks
To compare progression-free survival between treatment arms
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary Rodin study chair
Princess Margaret Hospital, Canada
Camilla Zimmerman study chair
Princess Margaret Hospital, Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EASE-psy in people with Acute Leukemia, run by Canadian Cancer Trials Group at 6 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Harriet Richardson (613-533-6430, hrichardson@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the Stanford Acute Stress Reaction questionnaire (SASRQ) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.