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NCT04571398 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04571398
Other study ID # AH0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 19, 2019
Est. completion date October 15, 2023

Study information
Verified date September 2020
Source Apricity Health, LLC
Contact Research Nurse Navigator
Phone 212-342-5162
Email cancerclinicaltrials@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date October 15, 2023
Est. primary completion date October 15, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• ApricityRx mobile application
AE detection and monitoring software

Locations
Country Name City State
United States Columbia University Irving Medical Center New York New York

Sponsors (1)
Lead Sponsor Collaborator
Apricity Health, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluate digital therapeutic mobile app to capture and transmit to care team patient-generated health data and access education content on IO and irAEs 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
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