Clinical trial NCT04224974: Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia
Official title: Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Leukemia
Lead sponsor: Canadian Cancer Trials Group
Sponsor class: NETWORK
Collaborators: name: Canadian Cancer Society (CCS)
name: Canadian Institutes of Health Research (CIHR)
name: Princess Margaret Hospital, University Health Network
First posted: 2020-01-13
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
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)
timeFrame: 4 weeks
measure: Assess the effect of the EASE intervention compared to usual care to reduce physical symptom severity using the Memorial Symptom Assessment Scale (MSAS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Assess the effect of the EASE intervention compared to usual care to reduce traumatic stress symptoms using the SASRQ
timeFrame: 8 weeks, 12 weeks & 26 weeks
measure: Assess the effect of the EASE intervention to usual care to reduce physical symptom severity using the MSAS
timeFrame: 8 weeks, 12 weeks & 26 weeks
measure: 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
timeFrame: 4, 8, 12 and 26 weeks
measure: 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
timeFrame: 4, 8, 12, 26 and 52 weeks
measure: Assess the effect of the EASE intervention compared to usual care on depressive symptoms using The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 4, 8 ,12 and 26 weeks
measure: 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)
timeFrame: 4, 8, 12 & 26 weeks
measure: Assess the effect of the EASE intervention compared to usual care on patient satisfaction with care using the 16-item FAMCAR-P16
timeFrame: 4, 8, 12 and 26 weeks
measure: Assess the effect of the EASE intervention compared to usual care on pain using the modified Brief Pain Inventory-Sort Form (BPI)
timeFrame: 4, 8 12 and 26 weeks
measure: 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.
timeFrame: Baseline
measure: 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
timeFrame: 4, 8, 12, 26 and 52 weeks
measure: To compare progression-free survival between treatment arms
timeFrame: 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre at Hamilton Health Sciences
state: Ontario
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, University Health Network
name: Gary Rodin
role: STUDY_CHAIR
affiliation: Princess Margaret Hospital, University Health Network
name: Camilla Zimmerman
role: STUDY_CHAIR
References: