CAR T-CELL Therapy Educational Video Trial

Browse trials for

• Hematologic Neoplasms 1,494

Keywords

• Hematologic Malignancy
• CAR-T cell therapy

Hematologic Neoplasms

1,494 studies on the registry are indexed under Hematologic Neoplasms; 438 are open to participants now.

This study's enrollment of 80 is above the median of 45 across 1,090 interventional studies indexed under Hematologic Neoplasms.

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.

Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Study arms

• Experimental
  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.

  Behavioral: Educational Video Tool

• No intervention
  Standard Care

  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

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.

Primary outcomes

1. 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.

   Time frame: Up to 1 year

Secondary outcomes

1. 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.

   Time frame: up to 1 month

2. 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.

   Time frame: up to 1 month

3. 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

   Time frame: up to 1 month

4. 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.

   Time frame: up to 1 week

5. 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.

   Time frame: up to 1 month

6. 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.

   Time frame: up to 1 month

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data can be shared no earlier than 1 year following the date of publication

Access criteria: Contact the Partners Innovations team at http://www.partners.org/innovation