NCT02353559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

1.7 years

First QC Date

January 28, 2015

Last Update Submit

September 26, 2019

Conditions

Acute Leukemia

Keywords

acute leukemiatraumatic stressquality of lifesymptom burdenpsychosocial oncologypalliative careinterventionhematological malignanciessupportive care

Outcome Measures

Primary Outcomes (1)

  • Stanford Acute Stress Reaction Questionnaire (SASRQ)

    A 30-item reliable and valid self-report measure of traumatic stress symptoms.

    12 weeks

Secondary Outcomes (8)

  • Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale (FACIT-Sp)

    12 weeks

  • Beck Depression Inventory-II (BDI-II)

    12 weeks

  • Brief Pain Inventory short form (BPI-sf)

    12 weeks

  • Memorial Symptom Assessment Scale (MSAS)

    12 weeks

  • Brief Experiences in Close Relationships Scale (ECR-M16)

    12 weeks

  • +3 more secondary outcomes

Study Arms (2)

EASE

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Usual care

Interventions

EASEBEHAVIORAL

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

EASE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (9)

  • Rodin G, Yuen D, Mischitelle A, Minden MD, Brandwein J, Schimmer A, Marmar C, Gagliese L, Lo C, Rydall A, Zimmermann C. Traumatic stress in acute leukemia. Psychooncology. 2013 Feb;22(2):299-307. doi: 10.1002/pon.2092. Epub 2011 Nov 13.

    PMID: 22081505BACKGROUND

  • Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, Moore M, Rydall A, Rodin G, Tannock I, Donner A, Lo C. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014 May 17;383(9930):1721-30. doi: 10.1016/S0140-6736(13)62416-2. Epub 2014 Feb 19.

    PMID: 24559581BACKGROUND

  • Zimmermann C, Yuen D, Mischitelle A, Minden MD, Brandwein JM, Schimmer A, Gagliese L, Lo C, Rydall A, Rodin G. Symptom burden and supportive care in patients with acute leukemia. Leuk Res. 2013 Jul;37(7):731-6. doi: 10.1016/j.leukres.2013.02.009. Epub 2013 Mar 11.

    PMID: 23490030BACKGROUND

  • Nissim R, Zimmermann C, Minden M, Rydall A, Yuen D, Mischitelle A, Gagliese L, Schimmer A, Rodin G. Abducted by the illness: a qualitative study of traumatic stress in individuals with acute leukemia. Leuk Res. 2013 May;37(5):496-502. doi: 10.1016/j.leukres.2012.12.007. Epub 2013 Jan 24.

    PMID: 23352641BACKGROUND

  • Nissim R, Rodin G, Schimmer A, Minden M, Rydall A, Yuen D, Mischitelle A, Fitzgerald P, Lo C, Gagliese L, Zimmermann C. Finding new bearings: a qualitative study on the transition from inpatient to ambulatory care of patients with acute myeloid leukemia. Support Care Cancer. 2014 Sep;22(9):2435-43. doi: 10.1007/s00520-014-2230-3. Epub 2014 Apr 5.

    PMID: 24705856BACKGROUND

  • Zimmermann C, Seccareccia D, Clarke A, Warr D, Rodin G. Bringing palliative care to a Canadian cancer center: the palliative care program at Princess Margaret Hospital. Support Care Cancer. 2006 Oct;14(10):982-7. doi: 10.1007/s00520-006-0093-y. Epub 2006 Jun 27.

    PMID: 16802127BACKGROUND

  • Rodin G, Deckert A, Tong E, Le LW, Rydall A, Schimmer A, Marmar CR, Lo C, Zimmermann C. Traumatic stress in patients with acute leukemia: A prospective cohort study. Psychooncology. 2018 Feb;27(2):515-523. doi: 10.1002/pon.4488. Epub 2017 Aug 10.

    PMID: 28665521BACKGROUND

  • Shaulov A, Rodin G, Popovic G, Caraiscos VB, Le LW, Rydall A, Schimmer AD, Zimmermann C. Pain in patients with newly diagnosed or relapsed acute leukemia. Support Care Cancer. 2019 Aug;27(8):2789-2797. doi: 10.1007/s00520-018-4583-5. Epub 2018 Dec 8.

    PMID: 30535882BACKGROUND

  • Rodin G, Malfitano C, Rydall A, Schimmer A, Marmar CM, Mah K, Lo C, Nissim R, Zimmermann C. Emotion And Symptom-focused Engagement (EASE): a randomized phase II trial of an integrated psychological and palliative care intervention for patients with acute leukemia. Support Care Cancer. 2020 Jan;28(1):163-176. doi: 10.1007/s00520-019-04723-2. Epub 2019 Apr 17.

    PMID: 31001692RESULT

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Gary Rodin, MD FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Camilla Zimmermann, MD PhD FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 2, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

CA(1)