Emotion and Symptom-Focused Engagement for Caregiver Burden

(EASE Trial)

Recruiting at 1 trial location

Overseen By Dr. Lindsay Jibb, RN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Cognitive impairment, Ongoing psychotherapy, Suicidal intention, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

306 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a psychotherapeutic intervention, so it's best to discuss your medications with the trial team.

What data supports the effectiveness of the treatment Emotion and Symptom-Focused Engagement (EASE) for reducing caregiver burden?

The study on Symptom Care at Home (SCH), a similar intervention, showed that automated digital coaching for family caregivers during home hospice care reduced overall caregiver burden compared to usual care. This suggests that structured support and coaching, like EASE, may help alleviate caregiver stress. ^{1 2 3 4 5}

How is the Emotion and Symptom-Focused Engagement (EASE) treatment different from other treatments for caregiver burden?

The EASE treatment is unique because it specifically targets the emotional and symptom-focused aspects of caregiver burden, such as worry about caregiving performance, which is a distinct factor from general role and personal strain. This approach may help improve caregivers' self-efficacy, especially in the early stages of burden, by addressing specific emotional challenges that other treatments might not focus on. ^{5 6 7 8 9}

Eligibility Criteria

This trial is for parents over 18 who are the main caregivers for a child under 18 with new or relapsed life-threatening cancer diagnosed in the last six months. They must be able to engage in therapy and complete questionnaires in English.

Inclusion Criteria

I can complete health measures and participate in activities in English.

I am 18 years old or older.

I am the main caregiver for my child who has recently been diagnosed with a serious cancer and is under 18.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Emotion and Symptom-focused Engagement (EASE) intervention and usual care over 12 weeks

12 weeks

8-12 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with questionnaires completed at 4, 8, and 12 weeks, and 6 months after enrolment

6 months

4 visits (virtual)

Treatment Details

Interventions

• Emotion and Symptom-Focused Engagement (EASE)

Trial Overview The study tests Emotion and Symptom-Focused Engagement (EASE), a psychotherapeutic approach, plus usual care versus usual care alone. It measures traumatic stress symptoms over six months using questionnaires at multiple points.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to the control group will receive usual care.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

The Hospital for Sick Children

Collaborator

Trials

724

Recruited

6,969,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Impact on caregiver burden of a patient-focused palliative care intervention for patients with advanced cancer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Trajectories of fatigue in family caregivers of patients undergoing radiation therapy for prostate cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of an automated, remote monitoring and coaching intervention in reducing hospice cancer family caregiving burden: A multisite randomized controlled trial. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

EVALUATE-AD and Tele-STAR: Novel Methodologies for Assessment of Caregiver Burden in a Telehealth Caregiver Intervention - A Case Study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Worry About Caregiving Performance: A Confirmatory Factor Analysis. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Sociocontextual circumstances in daily stress reactivity among caregivers for elder relatives. [2010]

7. England pubmed.ncbi.nlm.nih.gov

Factors emerging from the "Zarit Burden Interview" and predictive variables in a UK sample of caregivers for people with dementia. [2019]

8. China pubmed.ncbi.nlm.nih.gov

Behavioral health characteristics of a technology-enabled sample of Alzheimer's caregivers with high caregiver burden. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Reproducibility of the Caregiver Strain Index and the Caregiver Reaction Assessment in partners of stroke patients living in the Dutch community. [2022]