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Completed

NCT Number: NCT02353559

Emotion And Symptom-focused Engagement (EASE): 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.

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Key information

Conditions

Acute Leukemia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EASE

Behavioral

EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Cancer Society (CCS)

Registry information

Official study title

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

Acronym: EASE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2015
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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