Development of ImmunOncoTool

NCT04513678 | Completed DMC

• 1 other identifier: STU00207560
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Cancer, Treatment-Related

Keywords

eHealth; Symptom Burden; Health Related Quality of Life; Immunotherapy

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  20 weeks

Secondary Outcomes (3)

• Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G8)

  T1 (prior to starting intervention), T2 (immediately following 12 week intervention), T3 (2 months following intervention)

• Healthcare Utilization Form

  T2 (immediately following 12 week intervention), T3 (2 months following intervention)

• Immune Related Adverse Events (irAEs) are measured with the Health Questionnaire.

  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)

Study Arms (2)

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.

Behavioral: ImmunOncoTool Condition

Control

NO INTERVENTION

Participants in the control condition are not assigned an intervention. They receive standard of care.

Interventions

ImmunOncoTool Condition BEHAVIORAL

Immunotherapy education + irAE monitoring + Facilitation of patient-provider communication

Also known as: Experimental

ImmunOncoTool Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• American Cancer Society, Inc.: collaborator
• Bristol-Myers Squibb: collaborator
• Melanoma Research Foundation Breakthrough Consortium: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasms, Second Primary

Study Officials

• Betina Yanez, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 14, 2020
• Study Start: December 18, 2019
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)