← Back to Search

Behavioral Intervention

EASE-CG for Acute Leukemia Caregivers (EASE-CG Trial)

N/A

Recruiting

Led By Gary Rodin, MD FRCPC

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

EASE-CG Trial Summary

This trial will test a new intervention to help caregivers of acute leukemia patients manage their own psychological distress.

Who is the study for?

This trial is for adults fluent in English who are the main or co-main caregivers for someone recently diagnosed with acute leukemia. They must be providing care for a patient treated at Princess Margaret Cancer Centre or the Hospital for Sick Children within 3 months of diagnosis.Check my eligibility

What is being tested?

The EASE-CG pilot study is testing an adapted psychosocial intervention aimed to lessen traumatic stress and improve well-being in primary caregivers of acute leukemia patients.See study design

What are the potential side effects?

Since EASE-CG is a psychosocial intervention, it may not have physical side effects but can potentially cause emotional discomfort due to engagement with stressful topics.

EASE-CG Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PTSD Checklist for DSM-5 (PCL-5)

Stanford Acute Stress Reaction Questionnaire (SASRQ-II)

Secondary outcome measures

Brief Experiences in Close Relationships Scale (ECR-M16)

Caregiver Reaction Assessment (CRA) Scale

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

+3 more

EASE-CG Trial Design

1Treatment groups

Experimental Treatment

Group I: EASE-CG InterventionExperimental Treatment1 Intervention

Participants will be offered one EASE-CG therapy session every week for up to 12 weeks. Each session will last for approximately 30-60 minutes, delivered by a trained therapist at our center. Frequency and/or length of sessions may vary to accommodate the needs and availability of each participant. Outcomes will be assessed at baseline, 1, 3, 6, 9, and 12 months. Participants may be invited to brief, semi-structured interviews.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,474 Previous Clinical Trials

485,002 Total Patients Enrolled

The Hospital for Sick ChildrenOTHER

689 Previous Clinical Trials

6,945,381 Total Patients Enrolled

Gary Rodin, MD FRCPCPrincipal InvestigatorUniversity Health Network, Toronto

1 Previous Clinical Trials

47 Total Patients Enrolled

Media Library

EASE-CG (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05236296 — N/A

Acute Leukemia Research Study Groups: EASE-CG Intervention

Acute Leukemia Clinical Trial 2023: EASE-CG Highlights & Side Effects. Trial Name: NCT05236296 — N/A

EASE-CG (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05236296 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the principal goals of this trial?

"The primary metric used to evaluate patient response over a 12-week period is the Stanford Acute Stress Reaction Questionnaire (SASRQ). Secondary evaluations include: the Brief Experiences in Close Relationships Scale (ECR-M16) which measures attachment security, ENRICHD Social Support Instrument (ESSI), and Family Satisfaction with End-of-Life Care (FAMCARE) Scale."

Answered by AI

How many participants are actively participating in this research project?

"Affirmative. Clinicaltrials.gov offers evidence that this clinical investigation, which was first announced on April 12th 2022, is currently recruiting participants. The trial needs to enrol 40 people between two sites."

Answered by AI

Is this investigation actively enlisting participants?

"Affirmative. According to information accessible on clinicaltrials.gov, this medical research is recruiting participants now; it was initially listed on April 12th 2022 and has most recently been modified on May 3rd 2022. 40 patients must be enrolled at two sites for the trial to begin."

Answered by AI

Recent research and studies

Supportive Care in CancerJournal

Emotion and Symptom-focused Engagement (EASE): A Randomized Phase II Trial of an Integrated Psychological and Palliative Care Intervention for Patients with Acute Leukemia

Rodin, Gary, Carmine Malfitano, Anne Rydall, Aaron Schimmer, Charles M. Marmar, Kenneth Mah, Christopher Lo, Rinat Nissim, and Camilla Zimmermann. 2019. “Emotion and Symptom-focused Engagement (EASE): A Randomized Phase II Trial of an Integrated Psychological and Palliative Care Intervention for Patients with Acute Leukemia”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-019-04723-2.

clinicaltrials.govStudy

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

2022. "Emotion and Symptom-focused Engagement for Caregivers (EASE-CG) Pilot Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05236296.