Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06396702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-25
Brief Title:
EASE-SOT Pilot Study
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Emotion And Symptom-focused Engagement EASE Intervention for the Management of Emotional and Physical Symptoms Among Solid Organ Transplant Recipients-pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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 eg depression fatigue etc This report will contain customized embedded URL links to the Symptomcare public domain Embedded links will be in the form of httpssymptomcareorgmanaging-my-symptoms-overview-patientdepressionsubjectid1234tokenabcd If scoring above threshold for any symptom assessed during routine screening participants will be referredre-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
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 eg depression fatigue etc This report will contain customized embedded URL links to the Symptomcare public domain Embedded links will be in the form of httpssymptomcareorgmanaging-my-symptoms-overview-patientdepressionsubjectid1234tokenabcd If scoring above threshold for any symptom assessed during routine screening participants will be referredre-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None