Back to resultsCAR T-CELL Therapy Educational Video Trial
Primary Purpose
Hematologic Malignancy, CAR-T Cell Therapy
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Video Tool
Sponsored by
About this trial
This is an interventional supportive care trial for Hematologic Malignancy focused on measuring Hematologic Malignancy, CAR-T cell therapy
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational Video Tool
Standard Care
Arm Description
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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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.
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.
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.
Full Information
NCT ID
NCT04280133
First Posted
February 19, 2020
Last Updated
January 24, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04280133
Brief Title
CAR T-CELL Therapy Educational Video Trial
Official Title
A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2020 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
February 24, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, CAR-T Cell Therapy
Keywords
Hematologic Malignancy, CAR-T cell therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Video Tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Educational Video Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility (enrollment and retention rates)
Description
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.
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)
Description
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.
Time Frame
up to 1 month
Title
Psychological distress (Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
up to 1 month
Title
Patient's self-efficacy (modified version of CASE-cancer)
Description
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
Time Frame
up to 1 month
Title
Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)
Description
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.
Time Frame
up to 1 week
Title
Decision Satisfaction around receipt of CAR-T cell therapy
Description
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.
Time Frame
up to 1 month
Title
Acceptability of the video (intervention arm only)
Description
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.
Time Frame
up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick C Johnson, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation
Learn more about this trial
CAR T-CELL Therapy Educational Video Trial
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