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Development of ImmunOncoTool

NCT04513678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-04-07

No results posted yet for this study

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

Interventions

BEHAVIORAL

ImmunOncoTool Condition

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

Sponsors & Collaborators

Principal Investigators

  • Betina Yanez, PhD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-18
Primary Completion
2021-12-17
Completion
2021-12-17

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04513678 on ClinicalTrials.gov