Hematologic MalignancyNCT04280133
CAR T-CELL Therapy Educational Video Trial
A study testing Educational Video Tool in people with Hematologic Malignancy and CAR-T Cell Therapy, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, CAR-T Cell Therapy
- What is being tested?
- Educational Video Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2020to 24 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or age or older
- Established diagnosis of a hematologic malignancy
- Under consideration for CAR T-cell therapy at Massachusetts General Hospital
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy
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.
Read the 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.
- Conditions
- Hematologic Malignancy, CAR-T Cell Therapy
- Being tested
- Educational Video Tool
- Keywords
- Hematologic Malignancy, CAR-T cell therapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Video ToolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Educational Video Tool | Experimental | 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. Receives: Behavioral: Educational Video Tool |
| Standard Care | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (6)
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.
Measured: up to 1 month
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.
Measured: up to 1 month
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
Measured: up to 1 month
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.
Measured: up to 1 week
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.
Measured: up to 1 month
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.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start25 May 2020
- Primary completion26 Oct 2022
- Study completion24 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick C. Johnson, MD, Massachusetts General Hospital
- Investigators
- Patrick C Johnson, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280133
- Sponsor's protocol ID
- 19-790
- Status last verified
- Jan 2023
- First submitted
- 19 Feb 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of an Educational Video Tool for Patients Receiving CAR T-Cell Therapy
- ClinicalTrials.gov ID
- NCT04280133
- Acronym / sponsor ID
- 19-790
- Conditions
- Hematologic Malignancy, CAR-T Cell Therapy
- Keywords
- Hematologic Malignancy, CAR-T cell therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 25 May 2020 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 24 Feb 2023 (estimated)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Video Tool | Experimental | Behavioral: Educational Video ToolPatients 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. |
| Standard Care | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or age or older
- Established diagnosis of a hematologic malignancy
- Under consideration for CAR T-cell therapy at Massachusetts General Hospital
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Video ToolThe 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. | Behavioural | Educational Video Tool |
Primary outcome
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.
6 secondary outcomes
Knowledge about CAR-T cell therapy (CAR-T cell Knowledge Questionnaire)
Time frame: up to 1 month
Psychological distress (Hospital Anxiety and Depression Scale (HADS)
Time frame: up to 1 month
Patient's self-efficacy (modified version of CASE-cancer)
Time frame: up to 1 month
Preferences for CAR T-cell therapy (single-item preference for CAR-T cell therapy)
Time frame: up to 1 week
Decision Satisfaction around receipt of CAR-T cell therapy
Time frame: up to 1 month
Acceptability of the video (intervention arm only)
Time frame: up to 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick C Johnson, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Video Tool in people with Hematologic Malignancy and CAR-T Cell Therapy, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (enrollment and retention rates) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.