Recruiting

EASE

Sponsor:

University Health Network, Toronto

Code:

NCT06367556

Conditions

Trauma and Stressor Related Disorders

Pediatric Cancer

Caregiver Burden

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Emotion and Symptom-Focused Engagement (EASE)

Study Details

Brief 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. 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.

Conditions

Trauma and Stressor Related Disorders

Pediatric Cancer

Caregiver Burden

Study ID

NCT06367556

Start date

Feb 14, 2025

Status verified date

Dec, 2025

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

306 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment

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.

no intervention: Usual Care

Participants randomized to the control group will receive usual care.

Interventions

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.

Primary outcome measure

  • The Stanford Acute Stress Reaction Questionnaire [SASRQ] [ Time Frame: 6-months ]

Central Contacts and Locations

Central contacts

Dr. Lindsay Jibb, RN, PhD

416-813-7654lindsay.jibb@sickkids.ca

Elham Hashemi, MA

416-813-7654elham.hashemi@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Lindsay Jibb, RN, PhD

416-813-7654 x309160lindsay.jibb@sickkids.ca

Principal Investigator:

Lindsay Jibb, RN, PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-17.