CAR T-CELL Therapy Educational Video Trial

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04280133
• Other study ID #: 19-790
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: February 24, 2023

Study information

• Verified date: January 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: February 24, 2023
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CAR-T Cell Therapy
• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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