EASE for Organ Transplant Recipients

Overseen By Istvan Mucsi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: ICU, Clinically unstable, Delirium, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help organ transplant recipients manage physical and emotional symptoms affecting their quality of life. The treatment, EASE-SOT, combines supportive counseling sessions with regular check-ins on physical symptoms through questionnaires. Participants may qualify if they are awaiting or have recently received a kidney, liver, lung, or heart transplant at Toronto General Hospital. The trial will compare usual care to the EASE-SOT approach to determine its effectiveness in improving overall well-being for transplant patients. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance the quality of life for transplant recipients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring and managing symptoms rather than changing existing treatments.

What prior data suggests that the EASE intervention is safe for organ transplant recipients?

Research has shown that the EASE program, initially created for people with acute leukemia, is now being adapted for organ transplant patients. This program includes counseling and regular health check-ins using questionnaires, which help identify physical and emotional symptoms.

No serious safety issues have emerged with the EASE program itself. It focuses on monitoring and managing symptoms without medication or invasive procedures, making it generally safe for participants.

The adaptation of EASE for transplant patients remains in the early stages. However, by concentrating on counseling and symptom monitoring, the safety risks are minimal. This approach aims to help patients manage symptoms better, improving their overall quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about EASE-SOT for organ transplant recipients because it offers a comprehensive approach by integrating psychological and physical health monitoring. Unlike standard care, which typically focuses solely on physical symptoms, EASE-SOT includes EASE-psy sessions to address mental health, helping participants manage stress and emotional challenges post-transplant. Additionally, the use of electronic patient-reported outcome measures (ePROMs) provides real-time feedback on various health domains, allowing for timely interventions. This dual focus on mental and physical health, along with continuous monitoring, aims to enhance overall well-being and potentially improve transplant outcomes.

What evidence suggests that the EASE-SOT intervention is effective for managing symptoms in organ transplant recipients?

Research has shown that the EASE program, provided to participants in the EASE-SOT Intervention Arm of this trial, may assist patients in managing both physical and emotional symptoms. Originally developed for patients with acute leukemia, EASE includes supportive counseling and regular symptom check-ups. It tracks issues like anxiety, tiredness, and pain through patient feedback, helping doctors understand patient experiences and guide them to appropriate care. While specific data collection for organ transplant recipients continues, the EASE program aims to improve quality of life by addressing both mental and physical health needs. Early results suggest it could benefit those facing challenges after a transplant. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the EASE intervention, including 8 supportive counseling sessions and regular physical symptom assessments using ePROMs.

8 weeks

Twice a week during inpatient stay, then once every 1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with additional ePROMs completed at baseline, 4, 8, 12, and 20 weeks.

12 weeks

ePROMs at 4, 8, 12, and 20 weeks

Long-term Follow-up

Participants continue to be monitored for post-transplant quality of life and symptom severity using PROMIS and other measures.

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EASE-SOT

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

A pilot study involving 30 lung transplant recipients showed that a combination of group education and telephone coaching led to trends of lower weight gain and improved body composition compared to standard care over 12 months.

While the results were not statistically significant, the intervention group experienced less increase in weight, fat mass, and waist circumference, suggesting it may be a beneficial approach for managing weight post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can we HALT obesity following lung transplant? A Dietitian- and Physiotherapy-directed pilot intervention. Emsley, C., Snell, G., Paul, E., et al.[2022]

Out of 543 serious adverse events reported in organ donation from 2016 to 2022, 53 cases (9.8%) were identified as proven or probable transmissions of diseases to recipients, highlighting the importance of monitoring disease transmission in organ transplantation.

Infections were the most common type of disease transmission, and the mortality rate among recipients who received infected organs was notably high at 23%, with a particularly alarming 50% mortality rate when malignant diseases were transmitted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vigilance Data in Organ Donation and Solid Organ Transplantation in Germany: Six Years of Experience 2016-2022. Böhler, K., Rahmel, A., Barreiros, AP.[2023]

A new patient education tool was developed to support solid organ transplant recipients after early hospital discharge, addressing the challenges of ensuring patient and family understanding of post-transplant care.

This tool aims to enhance self-care practices, promote wellness, and improve graft survival by providing essential information that can be easily reviewed during home care visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-care guidelines: finding a common ground. Randolph, S., Scholz, K.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06396702

Study Details | NCT06396702 | EASE-SOT Pilot Study This is a parallel arm, randomized, controlled pilot study that will assess the feasibility for a large effectiveness trial using the EASE intervention to ...

2. withpower.com withpower.com/trial/phase-kidney-failure-kidney-transplant-4-2024-c69ac

EASE for Organ Transplant Recipients · Info for Participants The EASE-SOT Pilot Study is for organ transplant recipients experiencing physical and emotional symptoms post-transplant. It aims to help those who struggle ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1600613523006275

Results of a multicenter cluster-randomized controlled ... Introduction. Despite substantial improvements in short-term outcomes in solid organ transplant (SOT) recipients, optimal long-term outcomes remain elusive.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12271768/

Effectiveness and safety of strategies to optimise antimicrobial ... The outcomes assessed were mortality, transplant-related complications, infectious outcomes, development of antimicrobial resistance, ...

5. jscholarship.library.jhu.edu jscholarship.library.jhu.edu/items/4598bcfc-109a-41dd-941b-4fd72e4b738f

Strategies to Reduce Serious Infections in High-Risk Solid ... Most donors were taking effective antiretroviral therapy (ART); 20% showed severe immunosuppression. Although HIV drug resistance mutations were frequent, ...

6. clinicalmicrobiologyandinfection.org clinicalmicrobiologyandinfection.org/article/S1198-743X(22)00116-1/fulltext

Clinical outcome in solid organ transplant recipients ... Prospective or retrospective observational studies comparing clinical outcome in SOT recipients versus general populations affected by COVID-19 were included.