NCT05199961

Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Pack Health · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma, Large B-Cell, Diffuse

Interventions

Type	Name	Description
BEHAVIORAL	Digital Health Coaching	The digital health coaching program consists of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application. The program is 6-months in duration and designed for engagement following CAR T cell infusion.

Timeline

• Start date: 2022-01-25
• Primary completion: 2022-09-13
• Completion: 2022-09-13
• First posted: 2022-01-20
• Last updated: 2023-05-12

Locations

1 site across 1 country: United States