A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hematologic Malignancy
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Feasibility (enrollment and retention rates)
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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.
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.
Investigators
Patrick C. Johnson, MD
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Feasibility (enrollment and retention rates)
Time Frame: 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.
Secondary Outcomes
- Patient's self-efficacy (modified version of CASE-cancer)(up to 1 month)
- Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)(up to 1 week)
- Acceptability of the video (intervention arm only)(up to 1 month)
- Decision Satisfaction around receipt of CAR-T cell therapy(up to 1 month)
- Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)(up to 1 month)
- Psychological distress (Hospital Anxiety and Depression Scale (HADS)(up to 1 month)