CAR T-CELL Therapy Educational Video Trial

Study Overview
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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.

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

Conditions
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Hematologic Malignancy, CAR-T Cell Therapy

Intervention / Treatment
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* Behavioral: Educational Video Tool


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Video Tool<br>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<br>* 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.<br>|
| No Intervention: Standard Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematologic Malignancy, CAR-T cell therapy