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NCT05199961 · ClinicalTrials.gov registry record · NA
Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
A NA study, sponsored by Pack Health.
- Terminated
- Registry status
- NA
- Development phase
- 4
- Enrollment target
NCT05199961 is a NA study that was terminated before completion, run by Pack Health. The registered enrollment target is 4 participants.
The verdict
NCT05199961, a NA study, was terminated before completion, sponsored by Pack Health.
- TERMINATED
- Registry status
- NA
- Development phase
- 4 participants
- Enrollment target
Study Summary
The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individuals will be enrolled prior to tisagenlecleucel infusion in either the inpatient or ambulatory setting and followed for 6 months post-enrollment to evaluate changes in QOL from baseline to post-treatment, as measured by the Functional Assessment of Cancer Treatment- lymphoma (FACT-Lym). Secondary outcomes will assess patient self-efficacy in assessing for and managing treatment-related toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) and communicating these and other concerns across care settings. To support patients and facilitate the collection of key PROs, a digital health coaching solution provided by Pack Health will be provided to each participant over the 6-month study enrollment. The digital coaching program provides an evidence-based curriculum focused on monitoring and managing CAR T-cell associated toxicities, enhancing overall wellness post-treatment, and navigating within and between referring and treating facilities. The participating site(s) will collect longitudinal PRO data focused on QOL across physiologic and psychosocial domains that coaching personnel will access and review with participants.
Interventions
- BEHAVIORAL Digital Health Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2022-01-25 |
| Est. Completion | 2022-09-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05199961
The ClinicalTrials.gov registry entry for NCT05199961 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pack Health, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Digital Health Coaching is the first listed.
NCT05199961 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05199961 about?
NCT05199961 is a clinical study titled "Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel". The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individual...
What is the current status of trial NCT05199961?
This trial is currently terminated. It is a NA study. The enrollment target is 4 participants. The study started on 2022-01-25. Estimated completion is 2022-09-13.
What interventions are being tested in trial NCT05199961?
The interventions under investigation include: Digital Health Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT05199961?
This trial is sponsored by Pack Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
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