Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia (EASE)
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|ClinicalTrials.gov Identifier: NCT02353559|
Recruitment Status : Completed
First Posted : February 2, 2015
Last Update Posted : October 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Leukemia||Behavioral: EASE||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia|
|Actual Study Start Date :||March 2015|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
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.
EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.
No Intervention: Usual Care
- Stanford Acute Stress Reaction Questionnaire (SASRQ) [ Time Frame: 12 weeks ]A 30-item reliable and valid self-report measure of traumatic stress symptoms.
- Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp) [ Time Frame: 12 weeks ]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.
- Beck Depression Inventory-II (BDI-II) [ Time Frame: 12 weeks ]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.
- Brief Pain Inventory short form (BPI-sf) [ Time Frame: 12 weeks ]A 9-item reliable and valid self-report measure that assesses pain severity and the impact of pain on daily functioning.
- Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 12 weeks ]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.
- Brief Experiences in Close Relationships Scale (ECR-M16) [ Time Frame: 12 weeks ]A 16-item reliable and valid self-report measure of attachment security.
- FAMCARE-P16 [ Time Frame: 12 weeks ]A 16-item reliable and valid self-report measure of patient satisfaction with healthcare providers.
- Clinical Evaluation Questionnaire (CEQ) [ Time Frame: 12 weeks ]A 7-item measure developed for this study to evaluate the extent to which patients felt emotionally supported by the clinical services provided.
- Edmonton Symptom Assessment System - Acute Leukemia (ESAS-AL) [ Time Frame: 24 hours ]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).
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): NCT02353559
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Gary Rodin, MD FRCPC||University Health Network, Toronto|
|Principal Investigator:||Camilla Zimmermann, MD PhD FRCPC||University Health Network, Toronto|