NCT04571398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

2.9 years

First QC Date

September 25, 2020

Last Update Submit

September 25, 2020

Conditions

Cancer

Keywords

cancerimmunotherapycheckpoint inhibitorsimmune-related adverse events

Outcome Measures

Primary Outcomes (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

    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

Interventions

ApricityRx mobile applicationOTHER

AE detection and monitoring software

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Brian Henick, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Nurse Navigator

CONTACT

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2020

First Posted

October 1, 2020

Study Start

November 19, 2019

Primary Completion

October 15, 2022

Study Completion

October 15, 2023

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)