CAR T-CELL Therapy Educational Video Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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Group A: Educational video tool
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Group B: Standard care
Participants will be in the research study for a month after consent
It is expected that about 60 participants will take part in this research study.
Study Design
Arms and Interventions
| 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 |
Outcome Measures
Primary Outcome Measures
- Feasibility (enrollment and retention rates) [Up to 1 year]
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 and complete at least 60% of the intervention sessions.
Secondary Outcome Measures
- Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire) [up to 1 month]
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.
- Psychological distress (Hospital Anxiety and Depression Scale (HADS) [up to 1 month]
To compare patient's psychological distress between groups as measured by the HADS. HADS subscale ranges from 0-21, with higher scores indicating worse psychological distress.
- Patient's self-efficacy (CASE) [up to 1 month]
To compare patient's self-efficacy between the groups as measured by the Communication and Attitudinal Self-Efficacy Scale-Cancer (CASE-cancer). The CASE ranges from 0-170 with higher scores indicating higher self-efficacy
- Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy) [up to 1 week]
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.
- Decision Satisfaction around receipt of CAR-T cell therapy [up to 1 month]
To compare patient's satisfaction around the decision to receive CAR-T cell therapy between groups as measured by a six-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.
- Acceptability of the video (intervention arm only) [up to 1 month]
To assess, in the intervention group, 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 ranges from 0-3 with lower scores indicating higher acceptability of the video.
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years or age or older
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Established diagnosis of a hematologic malignancy
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Under consideration for CAR T-cell therapy at Massachusetts General Hospital
Exclusion Criteria:
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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
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Undergoing CAR T-cell therapy for solid tumor malignancy
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Inability to comprehend English, as the video is currently only available in English at this time
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-790