Recruiting

Observational Study

Sponsor:

Canadian Cancer Trials Group

Code:

NCT04224974

Conditions

Acute Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Usual Care

EASE-psy

Study Details

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

Study ID

NCT04224974

Start date

Jan 6, 2022

Status verified date

Jan, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

266 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Other: Usual Care

experimental: Behavioral: Usual Care + EASE Intervention-psy

EASE Intervention = EASE-psy + EASE-phys

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

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.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Harriet Richardson

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

Lois Shepherd

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

Locations

Juravinski Cancer Centre at Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Annette Hay

613 533-6430

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Pierre Villeneuve

613

Odette Cancer Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Lee Mozessohn

416 480-5000

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Gary Rodin

416 946-4504

More Information

Sponsor

Canadian Cancer Trials Group

Last update posted

Mar 27, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Canadian Cancer Trials Group on 2026-03-27.