CAR T-CELL Therapy Educational Video Trial

NCT04280133 | Unknown

• 1 other identifier: 19-790
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test a new educational video to help patients and doctors talk about CAR-T cell therapy, a treatment being used in cancer. \- Educational video tool for patients receiving CAR-T cell therapy.

Conditions

Hematologic Malignancy; CAR-T Cell Therapy

Keywords

Hematologic Malignancy; CAR-T cell therapy

Outcome Measures

Primary Outcomes (1)

• Feasibility (enrollment and retention rates)

  The primary endpoint is feasibility. The proposed video intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study.

  Up to 1 year

Secondary Outcomes (6)

• Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)

  up to 1 month

• Psychological distress (Hospital Anxiety and Depression Scale (HADS)

  up to 1 month

• Patient's self-efficacy (modified version of CASE-cancer)

  up to 1 month

• Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)

  up to 1 week

• Decision Satisfaction around receipt of CAR-T cell therapy

  up to 1 month

Study Arms (2)

Educational Video Tool

EXPERIMENTAL

Patients randomized to the intervention arm will watch a 3-minute video educational tool about CAR-T cell therapy prior to admission for CAR-T cell therapy.

Behavioral: Educational Video Tool

Standard Care

NO INTERVENTION

Patients randomized to the control arm will receive usual care per the treating team. Any questions regarding CAR-T cell therapy will be directed to the patient's medical team

Interventions

Educational Video Tool BEHAVIORAL

The video educational tool was written by the investigators in collaboration with a panel of experts on CAR T-cell therapy, medical ethicists, palliative care clinicians, and oncologists.

Educational Video Tool

Eligibility Criteria

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

You may qualify if:

• years or age or older
• Established diagnosis of a hematologic malignancy
• Under consideration for CAR T-cell therapy at Massachusetts General Hospital

You may not qualify if:

• Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or participation in the study
• Undergoing CAR T-cell therapy for solid tumor malignancy
• Inability to comprehend English, as the video is currently only available in English at this time

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Patrick C Johnson, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: May 25, 2020
• Primary Completion: October 26, 2022
• Study Completion: February 24, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)