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

• Sponsor: Apricity Health, LLC (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04571398
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 46.9
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: ApricityRx mobile application

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Study of ApricityRx™ Digital Therapeutic for Management of Immune-Related Adverse Events in Patients on Immuno-Oncology Therapy
• Actual Study Start Date: Nov 19, 2019
• Anticipated Primary Completion Date: Oct 15, 2022
• Anticipated Study Completion Date: Oct 15, 2023

Outcome Measures

Primary Outcome Measures

1. Evaluate digital therapeutic mobile app to capture and transmit to care team patient-generated health data and access education content on IO and irAEs [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Irving Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

• Apricity Health, LLC

Investigators

• Principal Investigator: Brian Henick, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Apricity Health, LLC
• ClinicalTrials.gov Identifier: NCT04571398
• Other Study ID Numbers: AH0001
• First Posted: Oct 1, 2020
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Apricity Health, LLC: cancer; immunotherapy; checkpoint inhibitors; immune-related adverse events

Study Results

No Results Posted as of Oct 1, 2020