Development of ImmunOncoTool — ACS-MRA  

Cancer Clinical Trial

Official title: Development of ImmunOncoTool: A Web-Based irAE Monitoring Platform

Status Completed

Clinical Trial 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.

Clinical Trial 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 5,071 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. ;

Related Conditions & MeSH terms

• Cancer
• Cancer, Treatment-Related
• Neoplasms, Second Primary

• NCT number: NCT04513678
• Study type: Interventional
• Source: Northwestern University
• Status: Completed
• Phase: N/A
• Start date: December 18, 2019
• Completion date: December 17, 2021