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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EASE

Intervention Type BEHAVIORAL

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

Usual Care

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EASE

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No