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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05199961
Recruitment Status : Terminated (Sponsor requested early termination)
First Posted : January 20, 2022
Last Update Posted : May 12, 2023
Sponsor:
Collaborators:
Novartis
Ohio State University Comprehensive Cancer Center
Information provided by (Responsible Party):
Pack Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Behavioral: Digital Health Coaching Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
Actual Study Start Date : January 25, 2022
Actual Primary Completion Date : September 13, 2022
Actual Study Completion Date : September 13, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm Cohort Receiving Digital Health Coaching
A single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of whom will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym) [ Time Frame: Change across Enrollment, Months 1,2,3,4,5,6 ]
    The FACT-lym is a 42-item assessment that measures self-reported quality of life across 4 domains: physical, functional, emotional and social and includes 15 additional items validated specifically for individuals with lymphoma. The instrument can be scored as a whole as well as within the individual domains.


Secondary Outcome Measures :
  1. SF-36 [ Time Frame: Enrollment, Months 3,6 ]
    The SF-36 is a validated measure for the assessment of health-related quality of life for individuals with diverse chronic conditions, including individuals with hematologic malignancies. It consists of 36-items assessing 8 health domains, including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health. The instrument is scored on a scale of 0-100 for each of the 8 health domains. It was recently used in a study of quality-of-life following treatment with tisagenlecleucel.

  2. Cancer Behavior Inventory- Brief (CBI-B) [ Time Frame: Enrollment, Months 1,2,3,4,5,6 ]
    This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".

  3. Subjective Assessment of Patient Experience in Managing CAR T Specific Care [ Time Frame: Enrollment, Months 1,2,3,4,5,6 ]
    As there are no currently validated instruments specific to CAR T-cell therapy, a 5-item assessment of patients' experience in monitoring, managing, and reporting treatment related toxicities will be created specifically for use in this study and will mirror the response scale in the CBI-B. This includes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident". The following items will be included: 1) Understand the treatment toxicities I may experience while receiving CAR T-cell therapy; 2) Identify the signs and symptoms of these toxicities; 3) Communicate symptoms to provider; 4) Manage symptoms according to provider's instructions; 5) Explain treatment to a healthcare provider


Other Outcome Measures:
  1. Socio-demographic, clinical, and treatment characteristics [ Time Frame: Through study completion, at month 6 ]
    Age, Race, Ethnicity, Sex at Birth, Gender Identity, Diagnosis, Treatment History, Co-morbid conditions, referring provider/institution, provider/institution for follow-up care, setting of CAR T-cell infusion

  2. Digital Engagement [ Time Frame: Through study completion, at month 6 ]
    Frequency, types and duration of engagement with the digital health coaching platform

  3. Treatment Response [ Time Frame: Months 3,6 ]
    Complete response, partial response, stable disease, progressive disease, unknown/not evaluated


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05199961


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Pack Health
Novartis
Ohio State University Comprehensive Cancer Center
Investigators
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Principal Investigator: Gretchen McNally, PhD The Ohio State University Comprehensive Cancer Center
More Information
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Additional Information:

Publications:

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Responsible Party: Pack Health
ClinicalTrials.gov Identifier: NCT05199961    
Other Study ID Numbers: 2021C0141
First Posted: January 20, 2022    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pack Health:
Quality of Life
Digital Health Coaching
adult
Receptors, Chimeric Antigen
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
 Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin