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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 : September 27, 2019
Sponsor:
Collaborator:
Canadian Cancer Society Research Institute (CCSRI)
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE January 28, 2015
First Posted Date  ICMJE February 2, 2015
Last Update Posted Date September 27, 2019
Actual Study Start Date  ICMJE March 2015
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
Stanford Acute Stress Reaction Questionnaire (SASRQ) [ Time Frame: 12 weeks ]
A 30-item reliable and valid self-report measure of traumatic stress symptoms.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02353559 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2017)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2015)
  • 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 34-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 assess perceived treatment and satisfaction with treatment for each symptom.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Emotion And Symptom-focused Engagement (EASE): An Intervention for Individuals With Acute Leukemia
Official Title  ICMJE Emotion And Symptom-focused Engagement (EASE): A Randomized Pilot Trial of an Intervention for Individuals With Acute Leukemia
Brief Summary 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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Leukemia
Intervention  ICMJE Behavioral: EASE
EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.
Study Arms  ICMJE
  • Experimental: EASE
    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.
    Intervention: Behavioral: EASE
  • No Intervention: Usual Care
    Usual care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2017)
47
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2015)
50
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02353559
Other Study ID Numbers  ICMJE 13-6631
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Canadian Cancer Society Research Institute (CCSRI)
Investigators  ICMJE
Principal Investigator: Gary Rodin, MD FRCPC University Health Network, Toronto
Principal Investigator: Camilla Zimmermann, MD PhD FRCPC University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP