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

NCT05362331 | Withdrawn

• 2 other identifiers: 212527NCI-2022-03845
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lymphoma; Leukemia; Plasma Cell Dyscrasia

Keywords

Web Application; CAR-T Therapy

Outcome Measures

Primary Outcomes (2)

• Percentage of participants who access all four CC web application modules at least once

  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.

  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 Outcomes (2)

• Number of times that temperature >= 38. degrees Celsius (°C) is reported

  Up to 26 days

• Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported

  Up to 26 days

Study Arms (1)

Companion for CAR-T Web Application (CC)

EXPERIMENTAL

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

Interventions

Web Application OTHER

Internet based application

Also known as: Companion for CAR-T Web Application, CAR-T Web Application (CC), CAR-T Web App

Companion for CAR-T Web Application (CC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Lymphoma; Leukemia; Paraproteinemias

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases; Blood Protein Disorders

Study Officials

• Rahul Banerjee, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: January 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share