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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

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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Behavioral: EASE Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
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.
Behavioral: EASE
EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.

No Intervention: Usual Care
Usual care



Primary Outcome Measures :
  1. Stanford Acute Stress Reaction Questionnaire (SASRQ) [ Time Frame: 12 weeks ]
    A 30-item reliable and valid self-report measure of traumatic stress symptoms.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Brief Experiences in Close Relationships Scale (ECR-M16) [ Time Frame: 12 weeks ]
    A 16-item reliable and valid self-report measure of attachment security.

  6. FAMCARE-P16 [ Time Frame: 12 weeks ]
    A 16-item reliable and valid self-report measure of patient satisfaction with healthcare providers.

  7. 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.

  8. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Canadian Cancer Society Research Institute (CCSRI)
Investigators
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Principal Investigator: Gary Rodin, MD FRCPC University Health Network, Toronto
Principal Investigator: Camilla Zimmermann, MD PhD FRCPC University Health Network, Toronto

Publications of Results:
Other Publications:

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02353559     History of Changes
Other Study ID Numbers: 13-6631
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Keywords provided by University Health Network, Toronto:
acute leukemia
traumatic stress
quality of life
symptom burden
psychosocial oncology
palliative care
intervention
hematological malignancies
supportive care
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes