CAR-T Cell Therapy, Hematologic Malignancy
Conditions
Keywords
Hematologic Malignancy, CAR-T cell therapy
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.
Interventions
BEHAVIORALEducational 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed