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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04571398
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Apricity Health, LLC

Study Description
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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
Cancer Other: ApricityRx mobile application

Study Design
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Study Type : Observational
Estimated 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 : November 19, 2019
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : October 15, 2023
Groups and Cohorts
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Intervention Details:
  • Other: ApricityRx mobile application
    AE detection and monitoring software

Outcome Measures
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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 [ 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Subject with a confirmed cancer diagnosis and prescribed checkpoint inhibitor therapy.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04571398


Contacts
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Contact: Research Nurse Navigator 212-342-5162 cancerclinicaltrials@cumc.columbia.edu

Locations
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United States, New York
Columbia University Irving Medical Center Recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Apricity Health, LLC
Investigators
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Principal Investigator: Brian Henick, MD Columbia University
More Information
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Responsible Party: Apricity Health, LLC
ClinicalTrials.gov Identifier: NCT04571398    
Other Study ID Numbers: AH0001
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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