EASE for Organ Transplant Recipients

Overseen By Istvan Mucsi

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Trial Summary

What is the purpose of this trial?

Many transplant recipients may experience physical and emotional symptoms, such as anxiety, fatigue, sleep problems, pain, etc. Often, these symptoms are not reported or managed well, and can affect a patient's quality-of-life. Transplant recipients are grateful for the "gift of life" but physical and emotional symptoms reduce their quality-of-life. Transplant recipients and caregivers have felt unprepared for the ongoing symptoms and reduced quality-of-life post-transplant. One way of monitoring and managing these symptoms is using the Emotion And Symptom-focused Engagement (EASE) intervention. EASE was originally developed for patients with acute leukemia and has begun to be adapted to help monitor and manage physical and emotional symptoms for organ transplant recipients. EASE is comprised of two components: 1. Psychological - 8 supportive counselling sessions delivered by mental health clinicians to address concerns about mental health, losses from organ failure, coping with a transplant, experiences with living on the brink of death for a prolonged period of time, etc. 2. Physical - Regular assessments of physical symptoms using questionnaires and referral to healthcare professionals for symptom management as necessary. EASE uses questionnaires, also called patient reported outcome measures (PROMs), for symptom assessment and monitoring. PROMs measure symptom severity, similarly to how bloodwork measures organ functioning. PROMs, as part of EASE, will ask recipients questions and help identify relevant physical, emotional, and social symptoms to enhance their care. With the help of specialists, patients, and support from the Kidney Foundation of Canada, our team has begun to adapt the EASE intervention for transplant recipients. In order to finalize the adaptation of the EASE intervention for use in a routine transplant clinic, we are launching a pre-pilot study to gain real-life experience from managing symptoms of SOT recipients with the use of EASE-SOT.

Eligibility Criteria

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.

Inclusion Criteria

Participants consented pre-transplant: Potential transplant recipients who are listed on the waitlist and identified by pre-transplant staff, recipients with a living donor arranged (pertaining to kidney and liver recipients), participants currently completing pre-transplant prehabilitation (pertaining to lung and heart recipients), or those who are on the top of their respective organ transplant waitlists.

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

Exclusion Criteria

Unwilling or unable to provide informed consent

Non-English speaking patients

Severe cognitive impairment as assessed by the recruitment and/or research team. This will be determined through communication with the organ transplant teams and by checking the patient's medical charts. If no cognitive impairment is indicated by the patient's organ transplant team or is documented in their medical chart, the patient will be assessed to have no cognitive impairment

Treatment Details

Interventions

• EASE-SOT (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: EASE-SOT Intervention Arm Experimental Treatment 1 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 Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+