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EASE for Organ Transplant Recipients

N/A

Waitlist Available

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

Participants consented post-transplant: Incident kidney, kidney-pancreas, liver, lung, or heart transplant recipients identified during index transplant hospital admission at the inpatient transplant unit of the Ajmera Transplant Centre at Toronto General Hospital

Be older than 18 years old

Must not have

Patients in ICU

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 20 (20 weeks)

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to help organ transplant recipients manage physical and emotional symptoms through the Emotion And Symptom-focused Engagement (EASE) intervention. EASE involves counseling sessions and regular assessments to address mental health

Who is the study for?

The EASE-SOT Pilot Study is for organ transplant recipients experiencing physical and emotional symptoms post-transplant. It aims to help those who struggle with anxiety, fatigue, sleep issues, and pain after receiving a kidney, liver, pancreas, heart or lung transplant.

What is being tested?

This study tests the Emotion And Symptom-focused Engagement (EASE) intervention adapted for transplant patients. It includes psychological support through counseling sessions and physical symptom assessments using questionnaires to improve overall care.

What are the potential side effects?

Since EASE-SOT primarily involves counseling and symptom assessment rather than medication or invasive procedures, side effects are minimal but may include discomfort from discussing personal experiences or emotions during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I consented to participate after receiving a transplant of kidney, liver, lung, heart, or kidney-pancreas at Ajmera Transplant Centre.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently in the Intensive Care Unit (ICU).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 20 (20 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 20 (20 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 20 (20 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adherence Rate

Clinical Team Acceptability

Consent Rate

+4 more

Secondary study objectives

Incidence Rate of Healthcare Use

Post-transplant Quality of Life using PROMIS physical and mental health summary scores

Post-transplant Quality of Life using the EQ-5D-5L

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: EASE-SOT Intervention ArmExperimental Treatment1 Intervention

Participants in the intervention group receive EASE plus usual care. Each participant will participate in 8 EASE-psy sessions, starting twice a week during the inpatient stay and once every 1-2 weeks thereafter. They will also be screened for physical symptoms using electronic patient-reported outcome measures (ePROMs) twice a week while in-patient and once a week during the rest of the 8-week intervention period (EASE-phys). Participants will receive an output report that provides graphic representation of their current and previous scores on the various domains of health (e.g., depression, fatigue, etc.). If scoring above threshold for any symptom assessed during routine screening, participants will be referred/re-referred to a "symptom control" team. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.

Group II: Control ArmActive Control1 Intervention

Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.

0 / 2Eligibility criteria met