Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513678
Status:
COMPLETED
Last Update Posted:
2022-04-07
First Post:
2020-08-07
Brief Title:
Development of ImmunOncoTool
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Development of ImmunOncoTool A Web-Based irAE Monitoring Platform
Status:
COMPLETED
Status Verified Date:
2022-04
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:
ACS-MRA
Brief Summary:
The purpose of this study is to facilitate the recognition and early management of Immune Related Adverse Events irAEs experienced by cancer patients taking immunotherapy This is done through the development of a web-based platform in which patients receive valuable education about irAEs patients irAEs are routinely monitored patient reported irAEs are embedded into patient clinical care and patient-provider communication and prompt management of irAEs is facilitated
The intervention component includes access to the web-based platform routine monitoring of irAEs every week for twelve weeks and then bi-weekly for an additional eight weeks and messages to healthcare providers and patients if a reported irAE is deemed severe enough that it warrants provider attention
Participants are randomized into either an intervention group described above or a control group in which their irAEs are monitored once after a twelve week interval and again after an additional eight weeks Additionally both intervention and control participants complete three assessments baseline at the beginning of the research study 12-week follow-up and 20-week follow-up
The intervention component includes access to the web-based platform routine monitoring of irAEs every week for twelve weeks and then bi-weekly for an additional eight weeks and messages to healthcare providers and patients if a reported irAE is deemed severe enough that it warrants provider attention
Participants are randomized into either an intervention group described above or a control group in which their irAEs are monitored once after a twelve week interval and again after an additional eight weeks Additionally both intervention and control participants complete three assessments baseline at the beginning of the research study 12-week follow-up and 20-week follow-up
Detailed Description:
Experiencing adverse events can compromise the clinical benefit of a cancer treatment and may go undetected by clinicians Specific to checkpoint inhibitors Immune Related Adverse Events irAEs include symptoms such as fatigue headaches skin reactions nausea or vomiting diarrhea as well as colitis liver toxicities and endocrinopathies A systematic review for 50 clinical trials with a total of 5071 patients receiving immune checkpoint inhibitors revealed that grade 3 or 4 irAEs were present in up to 66 of patients In general if irAEs are detected quickly they are reversible and manageable with immunosuppressive therapy However severe or life-threatening irAEs may lead to discontinuation of the checkpoint inhibitor which can lead to cancer progression and ultimately patient mortality Therefore prompt recognition and management of irAEs before they become severe can prevent irAEs that may be life-threatening as well as prevent discontinuation of checkpoint inhibitors
Web-based interventions provide flexibility and overcome many obstacles to accessibility for patients who may not be able to meet at a certain location due to disease-related physical limitations or logistical limitations Specific to cancer web-based interventions have demonstrated efficacy in reducing depressive symptoms distress and improved functional well-being among patients with cancer Finally web based platforms are useful for monitoring patient-reported outcomes and linking outcomes to providers Overall web-based monitoring and embedding of patient-reported adverse events into clinical care can improve cancer outcomes To the best of our knowledge no study has established the efficacy of a platform that links patient-reported irAEs to oncology providers
Our primary outcome will measure the feasibility of the digital health program ImmunOncoTool Our secondary outcome will be the preliminary intended effects of ImmunOncoTool which will be assessed through endpoints such as clinician response and time to clinician response of patient-reported irAEs number and length of unscheduled breaks in checkpoint inhibitor treatment and discontinuation of checkpoint inhibitor treatment length of time spent managing any irAEs provider reported irAEs and concurrence between patientreported irAE and provider reported irAEs as these factors may explain the effect of ImmunOncoTool on improved clinical outcomes
Web-based interventions provide flexibility and overcome many obstacles to accessibility for patients who may not be able to meet at a certain location due to disease-related physical limitations or logistical limitations Specific to cancer web-based interventions have demonstrated efficacy in reducing depressive symptoms distress and improved functional well-being among patients with cancer Finally web based platforms are useful for monitoring patient-reported outcomes and linking outcomes to providers Overall web-based monitoring and embedding of patient-reported adverse events into clinical care can improve cancer outcomes To the best of our knowledge no study has established the efficacy of a platform that links patient-reported irAEs to oncology providers
Our primary outcome will measure the feasibility of the digital health program ImmunOncoTool Our secondary outcome will be the preliminary intended effects of ImmunOncoTool which will be assessed through endpoints such as clinician response and time to clinician response of patient-reported irAEs number and length of unscheduled breaks in checkpoint inhibitor treatment and discontinuation of checkpoint inhibitor treatment length of time spent managing any irAEs provider reported irAEs and concurrence between patientreported irAE and provider reported irAEs as these factors may explain the effect of ImmunOncoTool on improved clinical outcomes
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