EASE-SOT Pilot Study

April 29, 2024 updated by: Istvan Mucsi, University Health Network, Toronto

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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&token=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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G2C4
        • Toronto General Hospital
        • Principal Investigator:
          • Istvan Mucsi, MD PHD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EASE-SOT Intervention Arm
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
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.
No Intervention: Control Arm
Participants in the control group receive usual care alone. Additional ePROMs will be completed at baseline, 4, 8, 12 and 20 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment Target
Time Frame: Baseline
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
Time Frame: Baseline
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
Time Frame: Baseline to week 8 (8 weeks)
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
Time Frame: Baseline to week 20 (20 weeks)
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
Time Frame: Baseline to week 20 (20 weeks)
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
Time Frame: Baseline to week 20 (20 weeks)
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
Time Frame: Baseline to week 20 (20 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Healthcare Use
Time Frame: Baseline to week 20 (20 weeks)
11-item recent healthcare use questions regarding healthcare use events such as recent hospitalizations, emergency visits, healthcare use. Incidence rates (event/100 patient years) of hospitalization, emergency admission, and hospitalization. Incidence rates will be compared between the two groups.
Baseline to week 20 (20 weeks)
Post-transplant Quality of Life using the EQ-5D-5L
Time Frame: Baseline to week 20 (20 weeks)
Measured by the the EuroQol-5 Dimension-5 Level (EQ5D5L) and Patient Reported Outcomes Measurement Information System (PROMIS) physical and mental health summary scores. The EQ5D5L measures quality of life (QOL) and utilities of health states by assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a single item for each domain, measured on five response levels. We will use the Canadian value set. The PROMIS physical and mental health summary scores are calculated using responses to the domain specific item banks included in the PROMIS 29+2 v2.1 Profile measure.
Baseline to week 20 (20 weeks)
Post-transplant Quality of Life using PROMIS physical and mental health summary scores
Time Frame: Baseline to week 20 (20 weeks)
The Patient Reported Outcome Measurement Information System (PROMIS) 29+2 v1.2 profile assesses pain intensity using a single 0-10 numeric rating item, cognitive function using 2 items, and seven additional domains of health (physical function, fatigue, pain interference, depression, anxiety, ability to participate in social roles and activities, and sleep disturbance). The seven additional domains of health will be assessed using computer adaptive testing (CAT). The PROMIS 29 scales are scored on a T-score metric with a mean score of 50 and standard deviation of 10. For symptom domains, a higher score indicates a higher severity of that symptom. For function domains, a higher score indicates less impairment. The PROMIS physical and mental health summary scores are calculated using responses to the domain specific item banks included in the PROMIS 29+2 v2.1 Profile measure.
Baseline to week 20 (20 weeks)
Presence of post-traumatic stress symptoms post-transplant using the SASRQ
Time Frame: Baseline to week 20 (20 weeks)
Measured by the Stanford Acute Stress Reaction Questionnaire (SASRQ). The SASRQ is a 30-item questionnaire used to measure traumatic stress symptoms, including anxiety and dissociation symptoms, using a valid and reliable scale. The instructions were modified to refer to organ failure and the transplant surgery as the "traumatic event".
Baseline to week 20 (20 weeks)
Presence of post-traumatic stress symptoms post-transplant using the PCL-5
Time Frame: Baseline to week 20 (20 weeks)
Measured by the Post-traumatic stress disorder checklist (PCL-5). The PCL-5 is a 20-item questionnaire used to measure traumatic stress using a valid and reliable scale. The self-report rating scale is 0-4 for each symptom, reflecting a change from 1-5 in the Diagnostic and Statistical Manual - IV (DSM-IV).
Baseline to week 20 (20 weeks)
Severity of physical and emotional symptoms post-transplant
Time Frame: Baseline to week 20 (20 weeks)
Measured by Patient Reported Outcomes Measurement Information System item banks administered using Computer Adaptive Testing (CAT) for anxiety, depression, dyspnea severity, fatigue, sleep disturbance, pain interference, pain intensity, physical function, cognitive function, and ability to participate in social roles and activities. For each domain specific item bank, responses to individual items are summed and converted into a standardized T-score, normalized to the US general population with a mean score of 50 and standard deviation of 10. For symptom domains, a higher score indicates a higher severity of that symptom. For function domains, a higher score indicates less impairment. When administered as CATs, 4 or more items are administered until standard error of measurement (SEM) is 0.30 or lower (equivalent to a reliability of 0.9 or higher) or 6 items have been asked. The recommended cut-off score for moderate-severe anxiety and depression symptoms on PROMIS tools is ≥60.
Baseline to week 20 (20 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Estimated)

May 2, 2024

Study Record Updates

Last Update Posted (Estimated)

May 2, 2024

Last Update Submitted That Met QC Criteria

April 29, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-6002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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