EASE-SOT Pilot Study

NCT06396702 | Not Yet Recruiting

• 1 other identifier: 22-6002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Physical - Regular assessments of physical symptoms using questionnaires and referral to healthcare professionals for symptom management as necessary.

Conditions

Transplant;Failure,Kidney; Transplant; Failure, Heart; Transplant; Failure, Liver; Transplant; Failure, Pancreas; Transplant; Failure, Lung(S)

Outcome Measures

Primary Outcomes (7)

• Recruitment Target

  Feasibility of the EASE-SOT intervention will be confirmed if our recruitment target of 120 participants (40 kidney and kidney-pancreas transplant recipients and 80 liver, lung, and heart transplant recipients) in a 30 month recruitment period is met.

  Baseline

• Consent Rate

  The consent rate describes the proportion of eligible patients who decline consent. Feasibility of the EASE-SOT intervention will be confirmed if the decline rate is ≤50%.

  Baseline

• Retention Rate

  The proportion of enrolled participants who continue to participate in the study at 8 weeks post-enrollment. Feasibility will be confirmed by a retention rate of 70%.

  Baseline to week 8 (8 weeks)

• Adherence Rate

  The proportion of enrolled participants who complete the EASE-Psy sessions, the symptom screening (EASE-phys) and outcome measures at the time offered, and have meetings the supportive care team if indicated by screens. Feasibility will be confirmed if ≥50% of participants complete EASE-psy sessions and symptom screening (EASE-phys) and outcome measures ≥50% of the time offered and have ≥1 meeting with the supportive care team if indicated by screens.

  Baseline to week 20 (20 weeks)

• Drop-out Rate

  The drop-out rate describes the proportion of enrolled participants who drop-out of the study for any reason (modality change, death, withdrawal, or loss to follow-up, etc.). Reasons for drop-out will be documented to assess the feasibility of the EASE-SOT intervention.

  Baseline to week 20 (20 weeks)

• Patient Acceptability

  Proportion of patients who find the EASE-SOT intervention 1) acceptable, 2) not burdensome, and 3) important based on responses to the "Patient Satisfaction Survey". Acceptability will be confirmed if \>80% of patients find EASE acceptable.

  Baseline to week 20 (20 weeks)

• Clinical Team Acceptability

  Proportion of staff who find the EASE-SOT intervention intrusive to workflow, based on responses to the "Staff Satisfaction Survey". Acceptability will be confirmed if \<20% of staff find the process intrusive to workflow.

  Baseline to week 20 (20 weeks)

Secondary Outcomes (6)

• Incidence Rate of Healthcare Use

  Baseline to week 20 (20 weeks)

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

  Baseline to week 20 (20 weeks)

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

  Baseline to week 20 (20 weeks)

• Presence of post-traumatic stress symptoms post-transplant using the SASRQ

  Baseline to week 20 (20 weeks)

• Presence of post-traumatic stress symptoms post-transplant using the PCL-5

  Baseline to week 20 (20 weeks)

Study Arms (2)

EASE-SOT Intervention Arm

EXPERIMENTAL

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.

Other: EASE-SOT

Control Arm

NO INTERVENTION

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

Interventions

EASE-SOT OTHER

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) using electronic patient reported outcome measures (ePROMs). The intervention duration is 8 weeks. Based on individual preference, EASE-psy may be administered in person or virtually via Microsoft Teams. Based on individual preference, participants may receive ePROMs either on tablets or to their personal electronic devices via email, while at the hospital ward and in clinics, ensuring easy access and administration of these tools.

EASE-SOT Intervention Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients in ICU.
• Patients who are clinically unstable, have delirium or other severe mental health concern requiring psychiatric treatment - assessed by clinical team.
• 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 patients organ transplant team or is documented in their medical chart, the patient will be assessed to have no cognitive impairment.
• Unwilling or unable to provide informed consent.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

Location

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Central Study Contacts

Istvan Mucsi

CONTACT

4166596756; istvan.mucsi@utoronto.ca

Ana M Samudio

CONTACT

4163404800; ana.samudio@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)