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

September 26, 2019 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stanford Acute Stress Reaction Questionnaire (SASRQ)
Time Frame: 12 weeks
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)
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.
12 weeks
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.
12 weeks
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.
12 weeks
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.
12 weeks
Brief Experiences in Close Relationships Scale (ECR-M16)
Time Frame: 12 weeks
A 16-item reliable and valid self-report measure of attachment security.
12 weeks
FAMCARE-P16
Time Frame: 12 weeks
A 16-item reliable and valid self-report measure of patient satisfaction with healthcare providers.
12 weeks
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.
12 weeks
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).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Cancer Society (CCS)

Investigators

  • Principal Investigator: Camilla Zimmermann, MD PhD FRCPC, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (ESTIMATE)

February 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-6631

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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