CAR T-CELL Therapy Educational Video Trial

NCT ID: NCT04280133

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2023-02-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematologic Malignancy CAR-T Cell Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Educational Video Tool

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Patrick C. Johnson, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick C Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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19-790

Identifier Type: -

Identifier Source: org_study_id

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