Clinical trial NCT04513678: Development of ImmunOncoTool
Official title: Development of ImmunOncoTool: A Web-Based irAE Monitoring Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cancer, Treatment-Related
Keywords: eHealth
Symptom Burden
Health Related Quality of Life
Immunotherapy
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Bristol-Myers Squibb
name: Melanoma Research Foundation Breakthrough Consortium
First posted: 2020-08-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Provider and electronic medical report (EMR) confirmed diagnosis of lung, kidney, urothelial, or melanoma cancer as checkpoint inhibitors are used primarily in these disease sites
* English-speaking as the content and website will only be available in English for feasibility testing
* Have initiated a checkpoint inhibitor
* Have access to the internet

Exclusion Criteria:

* significant cognitive impairment or inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis)
* concurrent cancer-related treatment aside from checkpoint inhibitors
* pre-existing auto-immune condition which may impact the course of treatment.

Primary outcomes:
measure: Demand of ImmunOncoTool: Recruitment Rate
timeFrame: 20 weeks
measure: Demand of ImmunOncoTool: Retention Rate
timeFrame: 20 weeks
measure: Acceptability of ImmunOncoTool
timeFrame: T2 (immediately following 12 week intervention)
measure: Engagement of ImmunOncoTool: Number of Login's
timeFrame: 20 weeks
measure: Engagement of ImmunOncoTool: Duration of Usage
timeFrame: 20 weeks
measure: Engagement of ImmunOncoTool: Content Accessed
timeFrame: 20 weeks
Secondary outcomes:
measure: Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G8)
timeFrame: T1 (prior to starting intervention), T2 (immediately following 12 week intervention), T3 (2 months following intervention)
measure: Healthcare Utilization Form
timeFrame: T2 (immediately following 12 week intervention), T3 (2 months following intervention)
measure: Immune Related Adverse Events (irAEs) are measured with the Health Questionnaire.
timeFrame: T1 (prior to starting intervention), every week during the 12 week intervention, T2 (immediately following 12 week intervention), biweekly for 8 weeks immediately following intervention, T3 (2 months following intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Betina Yanez, PhD
role: PRINCIPAL_INVESTIGATOR
References: