CAR T-CELL Therapy Educational Video Trial

A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematologic Malignancy; CAR-T Cell Therapy
• Intervention / Treatment: Behavioral: Educational Video Tool

Detailed Description

This research study is a Feasibility Study, which is the first-time investigators are examining this educational video tool for patients receiving CAR-T cell therapy.

The research study procedures include screening for eligibility, randomization and a series of questionnaires

Participants will be randomized to one of 2 groups:

• Group A: Educational video tool
• Group B: Standard care

Participants will be in the research study for a month after consent

It is expected that about 80 participants will take part in this research study.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

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:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational Video Tool; 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; 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.
No Intervention: Standard Care; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)	To compare patient's knowledge about CAR-T cell therapy between groups as measured by the CAR-T cell therapy Knowledge Questionnaire (Score range 0-10). Higher scores indicating higher knowledge.	up to 1 month
Psychological distress (Hospital Anxiety and Depression Scale (HADS)	To compare patient's psychological distress between groups as measured by the HADS. HADS Anxiety and Depression subscales range from 0-21, with higher scores indicating worse psychological distress.	up to 1 month
Patient's self-efficacy (modified version of CASE-cancer)	To compare patient's self-efficacy between the groups as measured by a modified version of the Communication and Attitudinal Self-Efficacy Scale-Cancer (CASE-cancer) for patients receiving CAR-T cell therapy. The modified CASE ranges from 0-170 with higher scores indicating higher self-efficacy	up to 1 month
Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)	To compare patient's preferences for CAR-T cell therapy between groups as measured by a single-item "Do you prefer to receive CAR-T cell therapy". We will compare proportion of patients stating "yes" to receiving CAR-T cell therapy between groups.	up to 1 week
Decision Satisfaction around receipt of CAR-T cell therapy	To compare patient's satisfaction around the decision to receive CAR-T cell therapy between groups as measured by a five-item Likert scale ranging from "Strongly Disagree" to "Strongly Agree" with statements about satisfaction regarding the decision to receive CAR-T cell therapy, with "Strongly Agree" indicating the highest decision satisfaction. We will compare the proportion of patients stating "Agree" or "Strongly Agree" to the six items between groups.	up to 1 month
Acceptability of the video (intervention arm only)	To assess, in the intervention group only, patients' comfort with watching the video, whether they find the video helpful in their understanding of CAR T-cell therapy, and whether they would recommend it to others as measured by a 3-item survey. Each of the three items is a four-point Likert scale. Acceptability is defined as at least 80% of patients intervention reporting they felt "very comfortable" or "somewhat comfortable" on a four-point Likert scale when asked about their comfort watching the video.	up to 1 month

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Patrick C Johnson, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): October 26, 2022
• Study Completion (Anticipated): February 24, 2023

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 19, 2020
• First Posted (Actual): February 21, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: CAR-T cell therapy; Hematologic Malignancy
• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 19-790

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No