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

ConditionAcute Leukemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Usual Care

    Other intervention

    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

    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.

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: Other: Usual CareExperimental treatment 1 intervention
Group B: Behavioral: Usual Care + EASE Intervention-psyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
4 weeks
2

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

Time frame
4 weeks

Secondary outcomes

1

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
2

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
3

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
4

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

Time frame
4, 8, 12, 26 and 52 weeks

Other outcomes

Sponsors and contacts

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Canadian Cancer Trials Group

Lead sponsor

Canadian Cancer Society (CCS)

Collaborator

Canadian Institutes of Health Research (CIHR)

Collaborator

Princess Margaret Hospital, Canada

Collaborator

Source ClinicalTrials.gov
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