Emotion and Symptom-Focused Engagement (EASE) for Caregivers

Pediatric Cancer Clinical Trial

— EASE  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06367556
• Other study ID #: 4542
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: October 1, 2028

Study information

• Verified date: April 2024
• Source: University Health Network, Toronto
• Contact: Lindsay Jibb, RN, PhD
• Phone: 416-813-7654
• Email: lindsay.jibb[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this two-site 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:

• Does EASE reduce traumatic stress symptom severity (primary outcome)?

To do so, researchers will compare parents receiving EASE to usual care. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 306
• Est. completion date: October 1, 2028
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Self-identified primary parental family caregiver/guardian (i.e., parent assuming the majority of care activities) of a child: i) 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); ii) <18 years of age; 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.

Related Conditions & MeSH terms

• Caregiver Burden
• Pediatric Cancer
• Trauma and Stressor Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR), The Hospital for Sick Children

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Traditional Masculinity-Femininity Scale [TMF]	This will be used to assess gender role.	Baseline
Other	Caregiver Reaction Assessment Scale [CRA]	This will be used to measure caregiver burden.	6-months
Other	ENRICHD Social Support Instrument [ESSI]	This will be used to measure perceived social support.	6-months
Other	Experiences in Close Relationships Scale [ECR-16]	This will be used to measure attachment security.	6-months
Other	Hope of Improvement subscale of the Therapy Expectation and Evaluation Scale [PATHEVH]	This will be used to assess expectation of EASE effectiveness in the treatment arm.	Baseline
Primary	Posttraumatic Stress Disorder Checklist for DSM-5 [PCL-5]	This will be used to measure traumatic stress symptoms.	6-months
Secondary	SF-36v2 Health Survey	This will be used to measure quality of life.	6-months
Secondary	Patient Health Questionnaire [PHQ-9]	This will be used to measure depressive symptoms.	6-months
Secondary	Caregiving Health Engagement Scale [CHE-s]	This will be used to measure parent capacity to care for their child.	6-months
Secondary	Family Adaptability and Cohesion Evaluation Scales III [FACES-III]	This will be used to measure parent perceived family functioning.	6-months
Secondary	Clinical Evaluation Questionnaire [CEQ]	This will be used to measure parent perceived benefit from interaction with clinicians.	6-months
Secondary	Family Satisfaction with End-of-Life Care Tool, 10-item version [FAMCARE-10]	This will be used to measure parent satisfaction with care.	6-months