A Study of ApricityRx™ for Management of IR-AEs in Patients on Immuno-Oncology Therapy

September 25, 2020 updated by: Apricity Health, LLC

A Study of ApricityRx™ Digital Therapeutic for Management of Immune-Related Adverse Events in Patients on Immuno-Oncology Therapy

Study of ApricityRx™ for Management of IR-AEs for patients on I-O therapy. Patients currently receiving immunotherapy will be asked to consent to participate in ApricityRx software platform mobile telephone application to report symptoms, view educational content in video form about IO and irAEs and communicate with site study team.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject with a confirmed cancer diagnosis and prescribed checkpoint inhibitor therapy.

Description

Inclusion Criteria:

  • Confirmed cancer diagnosis
  • Prescribed treatment with immune-checkpoint inhibitor
  • Age ≥ 18 years
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Uncomfortable with or unwilling to use digital or mobile technology
  • Lack of a smart phone with compatible operating systems: iOS version 10 and above, or Android 6.0 Marshmallow
  • Presence of any medical, psychological or social condition that, in the opinion of the investigator, would preclude participation in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate digital therapeutic mobile app to capture and transmit to care team patient-generated health data and access education content on IO and irAEs
Time Frame: 12 weeks
Number of times and percentage of study participants who use the app to report patient reported health data during a 12 week period and access education videos.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Apricity Health, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2019

Primary Completion (ANTICIPATED)

October 15, 2022

Study Completion (ANTICIPATED)

October 15, 2023

Study Registration Dates

First Submitted

September 25, 2020

First Submitted That Met QC Criteria

September 25, 2020

First Posted (ACTUAL)

October 1, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AH0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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