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Leukemia, AcuteEASE-CGNCT05236296

Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) Pilot Study

A study testing EASE-CG in people with Leukemia, Acute, run by University Health Network, Toronto at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the feasibility and acceptability of an adapted psychosocial intervention, called Emotion and Symptom-focused Engagement for Caregivers (EASE-CG), to reduce traumatic stress symptoms and other psychological distress and increase well-being in primary caregivers of patients newly… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Acute
What is being tested?
EASE-CG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesCanada
Study dates
12 Apr 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Self-identified primary caregiver (i.e., person assuming the majority of care activities) or co-primary caregiver (i.e., assuming at least 40% of care activities alongside another co-primary caregiver) of an adult or pediatric patient who is newly diagnosed with acute leukemia within 3 months of admission to the Princess Margaret Cancer Centre or the Hospital for Sick Children
  • Age ≥18 years
  • Fluency in English

Who cannot join

None listed.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Pilot Study of a Novel Psychotherapeutic Intervention for Caregivers of Patients With Acute Leukemia: Emotion and Symptom-focused Engagement for Caregivers (EASE-CG)

The purpose of this study is to test the feasibility and acceptability of an adapted psychosocial intervention, called Emotion and Symptom-focused Engagement for Caregivers (EASE-CG), to reduce traumatic stress symptoms and other psychological distress and increase well-being in primary caregivers of patients newly diagnosed with acute leukemia.

Read the detailed description

Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) is a brief psychotherapeutic intervention designed for primary caregivers of patients newly diagnosed with acute leukemia (AL). The EASE-CG intervention was adapted from a previous psychotherapeutic intervention for adult patients newly diagnosed with AL, called Emotion and Symptom-focused Engagement (EASE). In a previous pilot trial, EASE was associated with reductions in traumatic stress and physical symptom burden in adult patients with AL.

EASE-CG is a sub-study of a multi-center, longitudinal, mixed-methods study on the experience of traumatic stress in primary caregivers of patients newly diagnosed with AL within three months of admission to the hospital (Main study). The purpose of this sub-study is to conduct a non-randomized, mixed-methods pilot study to test the feasibility and acceptability of EASE-CG. A subset of caregivers of pediatric patients from the Main study will be approached to participate in EASE-CG. Quantitative measures will be administered at baseline, 1, 3 (primary endpoint), 6, 9, and 12 months (Main study endpoint). Participants may be invited to brief, semi-structured interviews.

The study will take place at the Hospital for Sick Children; the largest leukemia treatment center in Canada for pediatric patients.

Conditions
Leukemia, Acute
Being tested
EASE-CG
Keywords
Caregivers, Psychosocial Intervention, Traumatic Stress, Hematological Malignancies, Supportive Care, Acute Leukemia
Medical subject headings
Leukemia, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EASE-CGBehavioural

    EASE-CG is an adapted brief psychotherapeutic intervention with relational support and trauma-based cognitive behavioral therapy (CBT) components.

Study groups in NCT05236296
Study groupRoleWhat they receive
EASE-CG InterventionExperimentalParticipants will be offered one EASE-CG therapy session every week for up to 12 weeks. Each session will last for approximately 30-60 minutes, delivered by a trained therapist at our center. Frequency and/or length of sessions may vary to accommodate the needs and availability of each participant. Outcomes will be assessed at baseline, 1, 3, 6, 9, and 12 months. Participants may be invited to brief, semi-structured interviews.
Receives: Behavioral: EASE-CG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stanford Acute Stress Reaction Questionnaire (SASRQ-II)

    A 30-item reliable, valid, and widely used self-report measure assessing the severity of traumatic stress symptoms over the past four weeks. Total SASRQ scores may range from 0-150, with higher scores indicating increasingly severe traumatic stress symptoms. This measure has been updated to be Diagnostic and Statistical Manual of Mental Disorders (DSM-5)-concordant for acute stress disorder symptoms.

    Measured: 12 weeks

  2. PTSD Checklist for DSM-5 (PCL-5)

    A 20-item reliable and valid self-report measure of the presence and severity of post-traumatic stress disorder (PTSD) symptoms over the past month. Total PCL-5 scores may range from 0-80, with higher scores indicating increasingly severe PTSD symptoms. This DSM-5-concordant measure has been included to help validate the DSM-5-concordant version of the SASRQ.

    Measured: 12 weeks

Secondary outcomes (6)

  1. Brief Experiences in Close Relationships Scale (ECR-M16)

    A 16-item reliable and valid self-report measure of attachment security (i.e., the ability to rely on close others for support when distressed); in addition to a total score, it has subscales assessing anxious and avoidant attachment. Total ECR-M16 scores may range from 16-112, with higher scores indicating poorer attachment security (or greater attachment insecurity).

    Measured: 12 weeks

  2. Patient Health Questionnaire-9 (PHQ-9)

    A 9-item reliable and valid measure of depressive symptoms that has been widely used in patients with cancer. Total PHQ-9 scores may range from 0-27, with higher scores indicating increasingly severe depressive symptoms.

    Measured: 12 weeks

  3. Caregiver Reaction Assessment (CRA) Scale

    A 24-item reliable and valid measure of the positive and negative reactions to five dimensions of caregiver burden: (1) impact on schedule (i.e., disruption to usual daily activities) (5 items), (2) impact on finances (i.e., financial strain) (3 items), (3) lack of family support (5 items), (4) impact on caregiver's health (4 items), and (5) impact on caregiver's self-esteem (7 items). Higher scores indicate a stronger impact of caregiving on each dimension (either negative or positive). For dimensions 1-4, higher scores indicate higher negative experiences of caregiving. For dimension 5, higher scores indicate a higher level of positive caregiving experience. No overall summed score is used.

    Measured: 12 weeks

  4. Enhancing Recovery In Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI)

    A 7-item reliable and valid measure of the perceived availability of social support. Total ESSI scores may range from 6-31, with higher scores indicating greater perceived social support.

    Measured: 12 weeks

  5. Family Satisfaction with End-of-Life Care (FAMCARE) Scale

    A 20-item reliable and valid measure of satisfaction with health care practitioners' behaviour towards family caregivers and their loved ones with advanced cancer. Total FAMCARE scores may range from 20-100, with higher scores indicating greater caregiver satisfaction with health care practitioners.

    Measured: 12 weeks

  6. Traditional Masculinity-Femininity (TMF) Scale

    A 6-item reliable and valid measure of gender role, or the extent to which people view their interests, behaviour, attitudes and other aspects of themselves as masculine or feminine. Total TMF scores may range from 6-42, with higher scores indicating a greater sense of femininity. A score of four indicates an equal balance between masculine and feminine traits.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2022
  2. Study start12 Apr 2022
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
All study participants will receive the EASE-CG intervention.
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05236296
Sponsor's protocol ID
20-5452
Acronym
EASE-CG
Status last verified
Jul 2025
First submitted
1 Feb 2022
Last updated
17 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 31001692

  • Jibb LA, Yu A, Nanos S, Malfitano C, Foran L, Hunt K, Malakian A, Zimmermann C, Schultebraucks K, Pham NA, Rydall A, Alexander S, Rodin G. The Emotion and Symptom-Focused Engagement (EASE) Psychotherapeutic Intervention for Parents of Children With Acute Leukemia: A Feasibility Trial. Psychooncology. 2025 Nov;34(11):e70310. doi: 10.1002/pon.70310.

    PubMed 41161769

Questions about this trial

What is this clinical trial studying?

A study testing EASE-CG in people with Leukemia, Acute, run by University Health Network, Toronto at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stanford Acute Stress Reaction Questionnaire (SASRQ-II) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05236296, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2025.

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