EASE-SOT Pilot Study

Transplant;Failure,Kidney Clinical Trial

Official title: Emotion And Symptom-focused Engagement (EASE) Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is a parallel arm, randomized, controlled pilot study that will assess the feasibility for a large effectiveness trial using the EASE intervention to screen and manage emotional distress and physical symptoms among solid organ transplant (SOT) recipients. We will use a sequential cluster organization for recruitment. Initially, we will recruit kidney and kidney-pancreas transplant recipients, since we already have funding for this portion of our work. Subsequently, we will complete our study plan by recruiting liver, lung, and heart transplant recipients.

EASE integrates supportive counseling and trauma-focused cognitive behavioral therapy (CBT) (EASE-psy) with systematic physical symptom screening and triggered referral to supportive care to manage moderate to severe physical symptoms (EASE-phys). 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 week 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).

Based on individual preference, participants will receive these ePROMs either on tablets or their personal electronic devices via email, while in the hospital ward or in clinics, ensuring easy access and administration of these tools. 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.). This report will contain customized embedded URL links to the Symptomcare public domain. Embedded links will be in the form of: https://symptomcare.org/managing-my-symptoms-overview-patient/depression/?subjectid=1234&toke n=abcd. If scoring above threshold for any symptom assessed during routine screening, participants will be referred/re-referred to a "symptom control" team. Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8 12 and 20 weeks by patients in both arms. ;

Related Conditions & MeSH terms

• Renal Insufficiency
• Transplant; Failure, Heart
• Transplant; Failure, Liver
• Transplant; Failure, Pancreas
• Transplant;Failure,Kidney

• NCT number: NCT06396702
• Study type: Interventional
• Source: University Health Network, Toronto
• Contact: Istvan Mucsi
• Phone: 4166596756
• Email: istvan.mucsi@utoronto.ca
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Completion date: August 2027