- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04513678
Development of ImmunOncoTool (ACS-MRA)
Development of ImmunOncoTool: A Web-Based irAE Monitoring Platform
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ImmunOncoTool Condition
The ImmunOncoTool condition 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.
|
Immunotherapy education + irAE monitoring + Facilitation of patient-provider communication
Other Names:
|
NO_INTERVENTION: Control
Participants in the control condition are not assigned an intervention.
They receive standard of care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demand of ImmunOncoTool: Recruitment Rate
Time Frame: 20 weeks
|
We assess demand of the ImmunOncoTool application through study recruitment.
Based on previous psychosocial and behavioral studies in oncology, an 80% recruitment rate is considered an adequate level of demand.
|
20 weeks
|
Demand of ImmunOncoTool: Retention Rate
Time Frame: 20 weeks
|
Another way we assess demand of the ImmunOncoTool application is through participant retention.
Based on previous psychosocial and behavioral studies in oncology, an 80% retention rate is considered an adequate level of demand.
|
20 weeks
|
Acceptability of ImmunOncoTool
Time Frame: T2 (immediately following 12 week intervention)
|
To assess acceptability, all participants are asked to complete an exit interview on ImmunOncoTool.
This interview assesses usefulness, satisfaction, learnability and usability of the application.
This exit interview was synthesized from validated measures assessing eHealth intervention feasibility, and was adapted for our study to better fit our target population and our application design.
Above average scores on the questionnaire are considered acceptable.
The satisfaction questionnaire is administered over the phone immediately following the 12 week intervention.
|
T2 (immediately following 12 week intervention)
|
Engagement of ImmunOncoTool: Number of Login's
Time Frame: 20 weeks
|
We assess engagement of the ImmunOncoTool application by examining the number of participant logins to the web-based application.
|
20 weeks
|
Engagement of ImmunOncoTool: Duration of Usage
Time Frame: 20 weeks
|
We assess engagement of the ImmunOncoTool application by examining the duration participant time spent on the website.
Based on previous psychosocial and behavioral studies in oncology, an average of 8 hours of use is considered an adequate level of engagement.
|
20 weeks
|
Engagement of ImmunOncoTool: Content Accessed
Time Frame: 20 weeks
|
We assess engagement of the ImmunOncoTool application by examining the type of content accessed by participants on the website.
|
20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G8)
Time Frame: T1 (prior to starting intervention), T2 (immediately following 12 week intervention), T3 (2 months following intervention)
|
The FACT-G8 is a validated questionnaire that assesses top-rated symptoms and concerns for a broad spectrum of advanced cancers and serves as a health-related quality of life (HRQoL) measure.
|
T1 (prior to starting intervention), T2 (immediately following 12 week intervention), T3 (2 months following intervention)
|
Healthcare Utilization Form
Time Frame: T2 (immediately following 12 week intervention), T3 (2 months following intervention)
|
The Healthcare Utilization Form is used in order to capture possible medical events outside of the NU system that research staff was not able to catch through the patients' electronic medical record.
|
T2 (immediately following 12 week intervention), T3 (2 months following intervention)
|
Immune Related Adverse Events (irAEs) are measured with the Health Questionnaire.
Time Frame: 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)
|
The Health Questionnaire assesses the severity of symptoms patients may feel that often correspond with immunotherapy.
These symptoms can provide information regarding possible irAEs experienced by participants.
|
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)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00207560
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Case Comprehensive Cancer CenterCompletedStage IIA Rectal Cancer | Stage IIB Rectal Cancer | Stage IIC Rectal Cancer | Stage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Recurrent Colon Cancer | Recurrent Rectal Cancer | Stage IVA Colon Cancer | Stage IVA Rectal Cancer and other conditionsUnited States
Clinical Trials on ImmunOncoTool Condition
-
University of Colorado, BoulderNational Institute of Mental Health (NIMH)CompletedPhysical Activity | Affect
-
Universidade Federal de Sao CarlosCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.CompletedShoulder Impingement SyndromeBrazil
-
Rutgers, The State University of New JerseyRecruitingAggression | Problem Behavior | Self InjuryUnited States
-
University of MichiganCompleted
-
Columbia UniversityCompletedChronic Lung Disease | Cardiopulmonary DiseaseUnited States
-
Weill Medical College of Cornell UniversityNational Institute on Aging (NIA); Florida Institute for Human and Machine...CompletedPhysical Activity | Aging | Social IsolationUnited States
-
University of LausanneEmpa - Swiss Federal Laboratories for Materials Testing and Research, ZürichCompleted
-
University of California, IrvineCompleted
-
Nanyang Technological UniversityNational Museum of SingaporeUnknownLoneliness | Intergenerational Relations | Well AgingSingapore
-
Arizona State UniversityCompleted