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

NCT ID: NCT05362331

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

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.

Conditions

Lymphoma; Leukemia; Plasma Cell Dyscrasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Web Application

Intervention Type: OTHER

Internet based application

Interventions

Web Application

Internet based application

Intervention Type: OTHER

Other Intervention Names

Companion for CAR-T Web Application; CAR-T Web Application (CC); CAR-T Web App

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rahul Banerjee, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Other Identifiers

NCI-2022-03845

Identifier Type: REGISTRY

Identifier Source: secondary_id

212527

Identifier Type: -

Identifier Source: org_study_id