Companion for CAR-T Web App During Chimeric Antigen Receptor T-cell Therapy

February 6, 2023 updated by: University of California, San Francisco

Feasibility of a "Companion for CAR-T" Web App During Chimeric Antigen Receptor T-cell Therapy

The complex logistics and unique toxicities of chimeric antigen receptor T-cell (CAR-T) therapy require intensive patient education and careful monitoring. The Companion for CAR-T (CC) web app may be able to assist with patient education and preparation, communication between patients and their multidisciplinary teams, and home-based toxicity monitoring.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This is a single-arm pilot study assessing the feasibility and acceptability of the Companion for CAR-T (CC) web app among patients receiving commercially available CAR-T therapies.

Primary Objectives:

I. To evaluate the feasibility of the CC web app. II. To evaluate the acceptability of the CC web app to patients.

Secondary Objectives:

I. To quantify the incidence of fevers being reported via the CC web app. II. To quantify the incidence of electronic Immune Effector Cell-Associated Encephalopathy (eICE) deficits being recorded via the CC web app.

Exploratory Objectives:

I. To explore patient perceptions regarding the CC web app. II. To explore usage patterns regarding the CC web app. III. To explore trends in patient-reported quality of life (QOL), values, and stressors over time during CAR-T therapy.

IV. To explore responses to abnormal findings reported or recorded using the CC web app

Participants will be given access to the web application from beginning at the day of study enrollment through Day +100 following CAR-T therapy.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of a hematologic malignancy (including any plasma cell dyscrasia, any type of lymphoma, or any type of leukemia).
  • Planned receipt of an FDA-approved CAR-T therapy at University of California, San Francisco (UCSF) as standard of care.
  • Patient proficiency in spoken and written English.
  • Caregiver proficiency in spoken and written English.
  • Age >= 18 years old

Exclusion Criteria:

  • FDA-approved CAR-T therapy being administered as part of a prospective industry-sponsored trial, for example registrational trials of CAR-T therapy versus salvage chemotherapy or CAR-T therapy as an off-label line of therapy.

    *However, patients who receive an FDA-approved CAR-T therapy through an Expanded Access Program for non-conforming products (or any observational, non-interventional analysis of CAR-T products) are eligible.

  • Lack of ownership of a personal computing device, tablet device, or smartphone.

  • Refusal of patient and/or caregiver to sign up for a UCSF MyChart account.

    *Participants and caregivers who do not have a MyChart account at enrollment but are willing to create one will receive assistance from the study team to do so.

  • Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could - in the opinion of the study's Principal Investigator (PI) - interfere with provision of informed consent or compliance with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Companion for CAR-T Web Application (CC)
Enrolled participants and caregivers will receive access to the CC web application during the participants Chimeric Antigen Receptor T-cell (CAR-T) therapy. Key components include (1) educational videos and materials, (2) appointment calendars and 'Appointment Companion' features to prepare for clinical appointments, and (3) tools to assist with vital sign and neurological monitoring at home.
Other: Web Application
Internet based application
Other Names:
  • Companion for CAR-T Web Application
  • CAR-T Web Application (CC)
  • CAR-T Web App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who access all four CC web application modules at least once
Time Frame: Up to 6 months
The percentage of participants who access all four CC web application modules at least once from the date of study enrollment through Day +100 after CAR-T therapy will be reported. To meet the acceptability criteria, a threshold of 70% of participant engagement or higher must be met.
Up to 6 months
Percentage of participants agreeing or strongly agreeing with helpfulness of CC web application.
Time Frame: 1 day
Percentage of participants agreeing or strongly agreeing with the statement, "The Companion for CAR-T web app was helpful during my experience with CAR-T therapy." from a one time assessment administered between Day +29 and Day +100 following CAR-T therapy will be reported. This question ranks the helpfulness of the CC application on a scale of 1 (strongly disagree) to 5 (strongly agree). Participants must select an item score of 4 (agree) or 5 (strongly agree). To meet the feasibility criteria, a threshold of 70% of participant agreement or higher must be met.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of times that temperature >= 38. degrees Celsius (°C) is reported
Time Frame: Up to 26 days
The number of times (pooled across all patients) that an internal body temperature >= 38.0°C is reported by the participants via the CC web application between Day +2 to Day +28 following CAR-T therapy.
Up to 26 days
Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported
Time Frame: Up to 26 days
The number of times (pooled across all patients) that a new eICE deficit is recorded via the CC web application between Day +2 to Day +28 following CAR-T therapy.
Up to 26 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

January 1, 2023

Primary Completion (ANTICIPATED)

June 30, 2025

Study Completion (ANTICIPATED)

June 30, 2025

Study Registration Dates

First Submitted

May 2, 2022

First Submitted That Met QC Criteria

May 2, 2022

First Posted (ACTUAL)

May 5, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 6, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212527
  • NCI-2022-03845 (REGISTRY: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe