Clinical trial NCT06396702: EASE-SOT Pilot Study
Official title: Emotion And Symptom-focused Engagement (EASE) Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transplant;Failure,Kidney
Transplant; Failure, Heart
Transplant; Failure, Liver
Transplant; Failure, Pancreas
Transplant; Failure, Lung(S)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Target
timeFrame: Baseline
measure: Consent Rate
timeFrame: Baseline
measure: Retention Rate
timeFrame: Baseline to week 8 (8 weeks)
measure: Adherence Rate
timeFrame: Baseline to week 20 (20 weeks)
measure: Drop-out Rate
timeFrame: Baseline to week 20 (20 weeks)
measure: Patient Acceptability
timeFrame: Baseline to week 20 (20 weeks)
measure: Clinical Team Acceptability
timeFrame: Baseline to week 20 (20 weeks)
Secondary outcomes:
measure: Incidence Rate of Healthcare Use
timeFrame: Baseline to week 20 (20 weeks)
measure: Post-transplant Quality of Life using the EQ-5D-5L
timeFrame: Baseline to week 20 (20 weeks)
measure: Post-transplant Quality of Life using PROMIS physical and mental health summary scores
timeFrame: Baseline to week 20 (20 weeks)
measure: Presence of post-traumatic stress symptoms post-transplant using the SASRQ
timeFrame: Baseline to week 20 (20 weeks)
measure: Presence of post-traumatic stress symptoms post-transplant using the PCL-5
timeFrame: Baseline to week 20 (20 weeks)
measure: Severity of physical and emotional symptoms post-transplant
timeFrame: Baseline to week 20 (20 weeks)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
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