EASE-SOT Pilot Study

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Recruitment Target — 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.
• Consent Rate — 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%.
• Retention Rate — 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%.
• Adherence Rate — 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.
• Drop-out Rate — 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.
• Patient Acceptability — 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.
• Clinical Team Acceptability — 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.

Trial sites (1)

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