Trauma and Stressor Related DisordersEASENCT06367556
Emotion and Symptom-Focused Engagement (EASE) for Caregivers
A study testing Emotion and Symptom-Focused Engagement (EASE) in people with Trauma and Stressor Related Disorders and Pediatric Cancer, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
The goal of this Phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Trauma and Stressor Related Disorders, Pediatric Cancer, Caregiver Burden
- What is being tested?
- Emotion and Symptom-Focused Engagement (EASE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 2 sitesCanada
- Study dates
- 14 Feb 2025to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified primary family caregiver/guardian (i.e., parent assuming the majority of care activities) of a child: i) <18yo; ii) diagnosed with a new or relapsed life-threatening cancer within the preceding six months (disease-type eligibility per the Pediatric Oncology Group of Ontario Networked Information System); and iii) receiving active cancer therapy;
- Age ≥18 years; and,
- Able to complete outcome measures and engage in EASE in English, which need not be their first language.
Who cannot join
- Impairment in cognitive functioning or communication that would preclude participation in EASE sessions or outcome measure completion, as determined by the research team;
- Receiving formal ongoing psychotherapy at the time of recruitment;
- Active suicidal intention, based on an item in the Distress Assessment and Response Tool (DART) that has been widely used in suicidal intention screening in cancer; or,
- Child not expected to survive past the duration of trial, as determined by the child's medical team.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 1 recruiting
- Active, not recruiting
Princess Margaret Cancer Centre - University Health Network
Toronto, Ontario
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
Lindsay Jibb, RN, PhD, 416-813-7654 x309160, lindsay.jibb@sickkids.ca
Lindsay Jibb, RN, PhD
About this study
Official title: Emotion and Symptom-Focused Engagement (EASE) for Caregivers: A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Parents of Children With Cancer
The goal of this Phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:
- Is EASE plus usual care associated with less severe traumatic stress symptoms over six months, measured by area under the curve, when compared to usual care alone in the parents of children diagnosed with cancer in the preceding six months?
For the primary outcome analysis, area under the curve will be calculated for each participant. The statistical significance of the difference between arms will also be evaluated. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience.
- Being tested
- Emotion and Symptom-Focused Engagement (EASE)
- Medical subject headings
- Trauma and Stressor Related Disorders, Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion and Symptom-Focused Engagement (EASE)Behavioural
EASE sessions are directed to provide relational support, affect regulation, and problem-solving related to cancer in the child, to changes in spousal, family, and other relationships, and to the burden of multiple individual and family responsibilities.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants randomized to the intervention group will receive the Emotion and Symptom-focused Engagement (EASE) intervention and usual care. EASE consists of 8-12 psychotherapeutic sessions (~30-60 minutes each) delivered by a trained mental health clinician over 12 weeks. Receives: Behavioral: Emotion and Symptom-Focused Engagement (EASE) |
| Usual Care | No intervention | Participants randomized to the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Stanford Acute Stress Reaction Questionnaire [SASRQ]
SASRQ is a 30-item self-report measure with a rating scale of 0-30 (total range 0-150) that assesses the presence and severity of traumatic stress symptoms. Higher scores reflect greater severity.
Measured: 6-months
Secondary outcomes (7)
The PTSD Checklist for DSM-5 [PCL-5]
PCL-5 is a 20-item self-report measure with a rating scale of 0-4 (total range 0-80) that assesses the presence and severity of traumatic stress symptoms. Higher scores reflect greater severity.
Measured: 6-months
The SF-36v2 Health Survey
SF-36v2 consists of eight scales yielding two summary measures: physical and mental health. It can be scored using both norm-based scoring (NBS) algorithms and the original 0-100 scoring system, where higher scores indicate better health status.
Measured: 6-months
Patient Health Questionnaire [PHQ-9]
PHQ-9 is a 9-item measure with a rating scale of 0-3 (total range 0-27) that assesses the presence and severity of depressive symptoms. Higher scores reflect greater depression severity.
Measured: 6-months
Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC]
CSE-CSC is a 10-item scale (standardized score 0-100) of to measure the extent of self-efficacy of the caregiver when contributing to patient self-care in the complex care context. Higher scores indicate higher self-efficacy.
Measured: 6-months
Family Adaptability and Cohesion Evaluation Scales III [FACES-III]
FACES-III is a 20-item measure with a rating scale of 1-5 that will be used to assess parent perceived family functioning. 10-items measure family cohesion and 10-items measure adaptability (range 10-50, respectively), with higher scores for each domain indicating greater connectivity or flexibility compared to disengagement or rigidity.
Measured: 6-months
Clinical Evaluation Questionnaire [CEQ]
CEQ is a 7-item patient-reported experience measure with a rating scale of 0-4 that will assess the perceived benefits that caregivers experience in their interactions with healthcare providers in domains relevant to advanced cancer. A total score is calculated by summing the item scores where higher scores reflect greater perceived benefit.
Measured: 6-months
Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10]
FAMCARE-10 was developed to measure family caregiver satisfaction with the care of patients with advanced cancer with a rating scale of 0 (dissatisfied) to 2 (satisfied) where higher total scores reflect greater satisfaction.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start14 Feb 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma and Stressor Related DisordersStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Gary Rodin Research Team, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367556
- Sponsor's protocol ID
- 4542
- Acronym
- EASE
- Status last verified
- Dec 2025
- First submitted
- 10 Apr 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion and Symptom-Focused Engagement (EASE) for Caregivers: A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Parents of Children With Cancer
- ClinicalTrials.gov ID
- NCT06367556
- Acronym / sponsor ID
- EASE / 4542
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Canadian Institutes of Health Research (CIHR)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Phase III randomized controlled trial is to evaluate the effectiveness of a novel psychotherapeutic intervention called Emotion and Symptom-focused Engagement (EASE) in parents caring for a child or adolescent with cancer. The main question it aims to answer is:
- Is EASE plus usual care associated with less severe traumatic stress symptoms over six months, measured by area under the curve, when compared to usual care alone in the parents of children diagnosed with cancer in the preceding six months?
For the primary outcome analysis, area under the curve will be calculated for each participant. The statistical significance of the difference between arms will also be evaluated. Participants in both groups will complete questionnaires package at enrolment, and 4, 8, and 12 weeks, and 6 months after enrolment. They will also be invited to participate in optional qualitative interviews to better understand their experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Emotion and Symptom-Focused Engagement (EASE)Participants randomized to the intervention group will receive the Emotion and Symptom-focused Engagement (EASE) intervention and usual care. EASE consists of 8-12 psychotherapeutic sessions (~30-60 minutes each) delivered by a trained mental health clinician over 12 weeks. |
| Usual Care | No intervention | –Participants randomized to the control group will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified primary family caregiver/guardian (i.e., parent assuming the majority of care activities) of a child: i) <18yo; ii) diagnosed with a new or relapsed life-threatening cancer within the preceding six months (disease-type eligibility per the Pediatric Oncology Group of Ontario Networked Information System); and iii) receiving active cancer therapy;
- Age ≥18 years; and,
- Able to complete outcome measures and engage in EASE in English, which need not be their first language.
Key exclusion criteria (4 listed)
- Impairment in cognitive functioning or communication that would preclude participation in EASE sessions or outcome measure completion, as determined by the research team;
- Receiving formal ongoing psychotherapy at the time of recruitment;
- Active suicidal intention, based on an item in the Distress Assessment and Response Tool (DART) that has been widely used in suicidal intention screening in cancer; or,
- Child not expected to survive past the duration of trial, as determined by the child's medical team.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion and Symptom-Focused Engagement (EASE)EASE sessions are directed to provide relational support, affect regulation, and problem-solving related to cancer in the child, to changes in spousal, family, and other relationships, and to the burden of multiple individual and family responsibilities. | Behavioural | Treatment |
Primary outcome
The Stanford Acute Stress Reaction Questionnaire [SASRQ]
Time frame: 6-months
SASRQ is a 30-item self-report measure with a rating scale of 0-30 (total range 0-150) that assesses the presence and severity of traumatic stress symptoms. Higher scores reflect greater severity.
7 secondary outcomes
The PTSD Checklist for DSM-5 [PCL-5]
Time frame: 6-months
The SF-36v2 Health Survey
Time frame: 6-months
Patient Health Questionnaire [PHQ-9]
Time frame: 6-months
Caregiver Self-Efficacy in Contributing to Patient Self Care Scale [CSE-CSC]
Time frame: 6-months
Family Adaptability and Cohesion Evaluation Scales III [FACES-III]
Time frame: 6-months
Clinical Evaluation Questionnaire [CEQ]
Time frame: 6-months
Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10]
Time frame: 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion and Symptom-Focused Engagement (EASE) in people with Trauma and Stressor Related Disorders and Pediatric Cancer, 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 4 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: looking for participants now, as of the sponsor's last update on 17 Dec 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Lindsay Jibb, RN, PhD (416-813-7654 ext. 309160, lindsay.jibb@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Stanford Acute Stress Reaction Questionnaire [SASRQ] (time frame: 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.