Emotion and Symptom-Focused Engagement Trial for Individuals With Acute Leukemia (EASE)
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|ClinicalTrials.gov Identifier: NCT04224974|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 25, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia||Other: Usual Care Behavioral: EASE-psy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Emotion and Symptom-Focused Engagement (EASE): A Multi-Site Randomized Controlled Trial of an Intervention for Individuals With Acute Leukemia|
|Actual Study Start Date :||December 23, 2019|
|Estimated Primary Completion Date :||January 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
|Experimental: Other: Usual Care||
Other: 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
Experimental: Behavioral: Usual Care + EASE Intervention-psy
EASE Intervention = EASE-psy + EASE-phys
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.
- 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
- 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 ]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
- 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 ]Individual subscales of the FACIT-Sp provide scores for physical, social/family, emotional, functional spiritual well-being
- 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 ]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.
- 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 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
- 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 ]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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224974
|Contact: Harriet Richardsonfirstname.lastname@example.org|
|Contact: Lois Shepherdemail@example.com|
|Kingston Health Sciences Centre||Not yet recruiting|
|Kingston, Ontario, Canada, K7L 2V7|
|Contact: Annette Hay 613 533-6430 ext 77094|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Gary Rodin 416 946-4504|
|Study Chair:||Gary Rodin||Princess Margaret Hospital, University Health Network|
|Study Chair:||Camilla Zimmerman||Princess Margaret Hospital, University Health Network|