Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to test the feasibility of an individual psychological and physical symptom intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia.

Detailed Description
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This study involves the pilot-testing of a newly developed, brief manualized individual psychotherapy and physical symptom control intervention, called Emotion And Symptom-focused Engagement (EASE), to reduce traumatic stress and physical symptom burden in individuals newly diagnosed with acute leukemia. The purpose of this study is to conduct a two-arm randomized pilot trial (RPT) to test the feasibility, acceptability, and preliminary efficacy of EASE against usual care (UC) for the reduction of traumatic stress and physical symptom burden in patients with acute leukemia. Usual care for individuals with acute leukemia treated at the Princess Margaret Cancer Centre includes referral for non-standardized, and primarily instrumental, psychosocial care and palliative care service as needed. The design will be an unblinded RPT consisting of two conditions (EASE and UC), with a baseline assessment and follow-ups at 4, 8, and 12 weeks. The trial will take place at the Princess Margaret Cancer Centre, University Health Network; a comprehensive cancer center in Toronto, Canada. Participants will be newly diagnosed with acute leukemia, within one month of diagnosis and/or admission to hospital for treatment with curative intent.

Official Title
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Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia

Conditions
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Acute Leukemia

Intervention / Treatment
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* Behavioral: EASE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: new or relapsed diagnosis of acute leukemia (an amendment to allow recruitment of relapsed patients was approved on 24-Sep-2015, although no relapsed patients were ultimately recruited) will be receiving induction chemotherapy with curative intent and within 1 month of diagnosis and/or admission to hospital at the Princess Margaret Cancer Centre age ≥ 18 years fluency in English no cognitive impairment indicated in the medical record, communicated by the hematology clinical team, or determined by research staff at recruitment. Exclusion Criteria: inability to pass the cognitive screening test (Short Orientation-Memory Concentration Test [SOMC] score <20) actively receiving psychological/psychiatric counseling or palliative care services from the Department of Psychosocial Oncology and Palliative Care (POPC), now called the Department of Supportive Care, at the Princess Margaret Cancer Centre at the time of recruitment to this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EASE<br>Patients assigned to the intervention arm will receive 8 - 12 psychotherapy sessions lasting 30 - 60 minutes each, delivered by a trained therapist at our center. Patients will receive specialized symptom control from a nurse/physician team in our Palliative Care Service, when indicated by routine symptom screening. | Behavioral: EASE<br>* EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.<br>|
| No Intervention: Usual Care<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stanford Acute Stress Reaction Questionnaire (SASRQ) | A 30-item reliable and valid self-report measure of traumatic stress symptoms. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) | A 40-item reliable and valid self-report measure of overall quality of life, including 12 items that assess spiritual well-being, spiritual meaning and peace, and faith. | 12 weeks | 
| Beck Depression Inventory-II (BDI-II) | A 21-item reliable and valid self-report measure of the intensity of depressive symptoms, consistent with the DSM-V criteria for major depressive disorder. | 12 weeks | 
| Brief Pain Inventory short form (BPI-sf) | A 9-item reliable and valid self-report measure that assesses pain severity and the impact of pain on daily functioning. | 12 weeks | 
| Memorial Symptom Assessment Scale (MSAS) | A 32-item reliable and valid self-report inventory assessing the presence and severity of 26 common physical symptoms and 6 psychological symptoms of cancer. The scale has been adapted to reduce burden. A shortened version that omits frequency of symptoms and treatment, and satisfaction with treatment for each symptom was used. | 12 weeks | 
| Brief Experiences in Close Relationships Scale (ECR-M16) | A 16-item reliable and valid self-report measure of attachment security. | 12 weeks | 
| FAMCARE-P16 | A 16-item reliable and valid self-report measure of patient satisfaction with healthcare providers. | 12 weeks | 
| Clinical Evaluation Questionnaire (CEQ) | A 7-item measure developed for this study to evaluate the extent to which patients felt emotionally supported by the clinical services provided. | 12 weeks | 
| Edmonton Symptom Assessment System - Acute Leukemia (ESAS-AL) | A 14-item symptom severity assessment measure adapted for patients with acute leukemia to include prevalent and treatable symptoms in this population: mouth sores, diarrhea, itching, constipation, and insomnia. ESAS-AL was used as a screening tool as part of the clinical intervention, and was added as an outcome later in the trial (13-Apr-2016). | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute leukemia, traumatic stress, quality of life, symptom burden, psychosocial oncology, palliative care, intervention, hematological malignancies, supportive care