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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

Tracking Information
First Submitted Date September 25, 2020
First Posted Date October 1, 2020
Last Update Posted Date October 1, 2020
Actual Study Start Date November 19, 2019
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2020)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study of ApricityRx™ for Management of IR-AEs in Patients on Immuno-Oncology Therapy
Official Title A Study of ApricityRx™ Digital Therapeutic for Management of Immune-Related Adverse Events in Patients on Immuno-Oncology Therapy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subject with a confirmed cancer diagnosis and prescribed checkpoint inhibitor therapy.
Condition Cancer
Intervention Other: ApricityRx mobile application
AE detection and monitoring software
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 25, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 15, 2023
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Research Nurse Navigator 212-342-5162 cancerclinicaltrials@cumc.columbia.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04571398
Other Study ID Numbers AH0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Apricity Health, LLC
Study Sponsor Apricity Health, LLC
Collaborators Not Provided
Investigators
Principal Investigator: Brian Henick, MD Columbia University
PRS Account Apricity Health, LLC
Verification Date September 2020