CAR T-CELL Therapy Educational Video Trial
- Conditions
- Hematologic MalignancyCAR-T Cell Therapy
- Interventions
- Behavioral: Educational Video Tool
- Registration Number
- NCT04280133
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 18 years or age or older
- Established diagnosis of a hematologic malignancy
- Under consideration for CAR T-cell therapy at Massachusetts General Hospital
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Educational Video Tool 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Patient's self-efficacy (modified version of CASE-cancer) up to 1 month 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
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.
Acceptability of the video (intervention arm only) up to 1 month 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.
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 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.
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 Anxiety and Depression subscales range from 0-21, with higher scores indicating worse psychological distress.
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States