A Study of ApricityRx™ for Management of IR-AEs in Patien... | NCT04571398

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

NCT04571398

Sponsor

Apricity Health, Inc

Status

Unknown status

Last Update Posted

Oct 1, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Cancer

Interventions

ApricityRx mobile application

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2019Actual

Primary Completion Date

Oct 15, 2022Estimated

Completion Date

Oct 15, 2023Estimated

First Submitted Date

Sep 25, 2020

First Submission Date that Met QC Criteria

Sep 25, 2020

First Posted Date

Oct 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2020

Last Update Posted Date

Oct 1, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ApricityRx mobile application	Other	AE detection and monitoring software

Outcomes Module

Primary Outcomes

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	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Research Nurse Navigator	Contact	212-342-5162		cancerclinicaltrials@cumc.columbia.edu

Overall Officials

Name	Affiliation	Role
Brian Henick, MD	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Irving Medical Center	Recruiting	New York	New York	10032	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided