Clinical trial NCT05199961: Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
Official title: Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: Quality of Life
Digital Health Coaching
adult
Receptors, Chimeric Antigen
Lead sponsor: Pack Health
Sponsor class: INDUSTRY
Collaborators: name: Novartis
name: Ohio State University Comprehensive Cancer Center
First posted: 2022-01-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of which will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center.
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 and older
* Able to read, speak and consent in English
* Diagnosis of diffuse large b-cell lymphoma
* Confirmed treatment with tisagenlecleucel (Kymriah)
* Internet access via smartphone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.

Exclusion Criteria:

* Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
* Individuals for whom there is documentation of inability to provide consent in the medical record

Primary outcomes:
measure: Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)
timeFrame: Change across Enrollment, Months 1,2,3,4,5,6
Secondary outcomes:
measure: SF-36
timeFrame: Enrollment, Months 3,6
measure: Cancer Behavior Inventory- Brief (CBI-B)
timeFrame: Enrollment, Months 1,2,3,4,5,6
measure: Subjective Assessment of Patient Experience in Managing CAR T Specific Care
timeFrame: Enrollment, Months 1,2,3,4,5,6
Other outcomes:
measure: Socio-demographic, clinical, and treatment characteristics
timeFrame: Through study completion, at month 6
measure: Digital Engagement
timeFrame: Through study completion, at month 6
measure: Treatment Response
timeFrame: Months 3,6
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Ohio State University Comprehensive Cancer Center
name: Gretchen McNally, PhD
role: PRINCIPAL_INVESTIGATOR
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