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

Primary Purpose

Lymphoma, Leukemia, Plasma Cell Dyscrasia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web Application
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lymphoma focused on measuring Web Application, CAR-T Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Companion for CAR-T Web Application (CC)

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Number of times that temperature >= 38. degrees Celsius (°C) is reported
    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.
    Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported
    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.

    Full Information

    First Posted
    May 2, 2022
    Last Updated
    February 6, 2023
    Sponsor
    University of California, San Francisco
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05362331
    Brief Title
    Companion for CAR-T Web App During Chimeric Antigen Receptor T-cell Therapy
    Official Title
    Feasibility of a "Companion for CAR-T" Web App During Chimeric Antigen Receptor T-cell Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Contract issues
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of California, San Francisco

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma, Leukemia, Plasma Cell Dyscrasia
    Keywords
    Web Application, CAR-T Therapy

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Companion for CAR-T Web Application (CC)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Web Application
    Other Intervention Name(s)
    Companion for CAR-T Web Application, CAR-T Web Application (CC), CAR-T Web App
    Intervention Description
    Internet based application
    Primary Outcome Measure Information:
    Title
    Percentage of participants who access all four CC web application modules at least once
    Description
    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.
    Time Frame
    Up to 6 months
    Title
    Percentage of participants agreeing or strongly agreeing with helpfulness of CC web application.
    Description
    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.
    Time Frame
    1 day
    Secondary Outcome Measure Information:
    Title
    Number of times that temperature >= 38. degrees Celsius (°C) is reported
    Description
    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.
    Time Frame
    Up to 26 days
    Title
    Number of times an Electronic immune effector-cell associated encephalopathy assessment (eICE) is reported
    Description
    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.
    Time Frame
    Up to 26 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rahul Banerjee, MD
    Organizational Affiliation
    University of California, San Francisco
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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