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Completed

NCT Number: NCT05236296

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

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.

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Key information

Conditions

Leukemia, Acute Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Leukemia Neoplasms Neoplasms by Histologic Type 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, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

none

Treatment and study plan

EASE-CG

Behavioral

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

Primary outcomes

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

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 12 weeks

    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).

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

    Time frame: 12 weeks

    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.

  3. Caregiver Reaction Assessment (CRA) Scale

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

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

    Time frame: 12 weeks

    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.

  6. Traditional Masculinity-Femininity (TMF) Scale

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

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

Acronym: EASE-CG

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2022
Registry last updated
Jul 17, 2025

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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