CancerACS-MRANCT04513678
Development of ImmunOncoTool
A study testing ImmunOncoTool Condition in people with Cancer and Cancer, Treatment-Related, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Cancer, Treatment-Related
- What is being tested?
- ImmunOncoTool Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 17 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cancer, Cancer, Treatment-Related
- Being tested
- ImmunOncoTool Condition
- Keywords
- eHealth, Symptom Burden, Health Related Quality of Life, Immunotherapy
- Medical subject headings
- Neoplasms, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunOncoTool ConditionBehavioural
Also called Experimental
Immunotherapy education + irAE monitoring + Facilitation of patient-provider communication
| Study group | Role | What they receive |
|---|---|---|
| ImmunOncoTool Condition | Experimental | 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. Receives: Behavioral: ImmunOncoTool Condition |
| Control | No intervention | Participants in the control condition are not assigned an intervention. They receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demand of ImmunOncoTool: Recruitment Rate
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.
Measured: 20 weeks
Demand of ImmunOncoTool: Retention Rate
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.
Measured: 20 weeks
Acceptability of ImmunOncoTool
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.
Measured: T2 (immediately following 12 week intervention)
Engagement of ImmunOncoTool: Number of Login's
We assess engagement of the ImmunOncoTool application by examining the number of participant logins to the web-based application.
Measured: 20 weeks
Engagement of ImmunOncoTool: Duration of Usage
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.
Measured: 20 weeks
Engagement of ImmunOncoTool: Content Accessed
We assess engagement of the ImmunOncoTool application by examining the type of content accessed by participants on the website.
Measured: 20 weeks
Secondary outcomes (3)
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G8)
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.
Measured: T1 (prior to starting intervention), T2 (immediately following 12 week intervention), T3 (2 months following intervention)
Healthcare Utilization Form
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.
Measured: T2 (immediately following 12 week intervention), T3 (2 months following intervention)
Immune Related Adverse Events (irAEs) are measured with the Health Questionnaire.
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start18 Dec 2019
- Primary completion17 Dec 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc., Bristol-Myers Squibb, Melanoma Research Foundation Breakthrough Consortium
- Responsible party
- Principal investigator, Betina Yanez, Northwestern University
- Investigators
- Betina Yanez, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04513678
- Sponsor's protocol ID
- STU00207560
- Acronym
- ACS-MRA
- Status last verified
- Apr 2022
- First submitted
- 7 Aug 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with any researchers outside Northwestern.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of ImmunOncoTool: A Web-Based irAE Monitoring Platform
- ClinicalTrials.gov ID
- NCT04513678
- Acronym / sponsor ID
- ACS-MRA / STU00207560
- Conditions
- Cancer, Cancer, Treatment-Related
- Keywords
- eHealth, Symptom Burden, Health Related Quality of Life, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc., Bristol-Myers Squibb, Melanoma Research Foundation Breakthrough Consortium
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 17 Dec 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ImmunOncoTool Condition | Experimental | Behavioral: ImmunOncoTool ConditionThe 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. |
| Control | No intervention | –Participants in the control condition are not assigned an intervention. They receive standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunOncoTool ConditionAlso: ExperimentalImmunotherapy education + irAE monitoring + Facilitation of patient-provider communication | Behavioural | ImmunOncoTool Condition |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
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)
Healthcare Utilization Form
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with any researchers outside Northwestern.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betina Yanez, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ImmunOncoTool Condition in people with Cancer and Cancer, Treatment-Related, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demand of ImmunOncoTool: Recruitment Rate (time frame: 20 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022.