Study Summary
This trial is designed to evaluate quality of life and patient-reported outcomes following CAR T-cell therapy with tisagenlecleucel in adults with diffuse large b-cell lymphoma.
Eligible Conditions
- Diffuse Large B-Cell Lymphoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: Enrollment, Months 1,2,3,4,5,6
Month 1
Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)
Enrollment, Months 1,2,3,4,5,6
Cancer Behavior Inventory- Brief (CBI-B)
Subjective Assessment of Patient Experience in Managing CAR T Specific Care
Enrollment, Months 3,6
SF-36
Months 3,6
Treatment Response
Month 6
Digital Engagement
Socio-demographic, clinical, and treatment characteristics
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Single Arm Cohort Receiving Digital Health Coaching
1 of 1
Experimental Treatment
100 Total Participants · 1 Treatment Group
Primary Treatment: Digital Health Coaching · No Placebo Group · N/A
Single Arm Cohort Receiving Digital Health Coaching
Behavioral
Experimental Group · 1 Intervention: Digital Health Coaching · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: enrollment, months 1,2,3,4,5,6
Who is running the clinical trial?
Pack HealthLead Sponsor
4 Previous Clinical Trials
904 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterOTHER
290 Previous Clinical Trials
286,039 Total Patients Enrolled
NovartisIndustry Sponsor
1,588 Previous Clinical Trials
2,703,872 Total Patients Enrolled
Gretchen McNally, PhDPrincipal InvestigatorThe Ohio State University Comprehensive Cancer Center
Eligibility Criteria
Age 18 - 90 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- “Adult Survivorship: Considerations Following CAR T-cell Therapy”. 2019. “Adult Survivorship: Considerations Following CAR T-cell Therapy”. Clinical Journal of Oncology Nursing. Oncology Nursing Society (ONS). doi:10.1188/19.cjon.s1.42-48.
- Chakraborty, Rajshekhar, Surbhi Sidana, Gunjan L. Shah, Michael Scordo, Betty K. Hamilton, and Navneet S. Majhail. 2019. “Patient-reported Outcomes with Chimeric Antigen Receptor T Cell Therapy: Challenges and Opportunities”. Biology of Blood and Marrow Transplantation. Elsevier BV. doi:10.1016/j.bbmt.2018.11.025.
- “Management Across Settings: An Ambulatory and Community Perspective for Patients Undergoing CAR T-cell Therapy in Multiple Care Settings”. 2019. “Management Across Settings: An Ambulatory and Community Perspective for Patients Undergoing CAR T-cell Therapy in Multiple Care Settings”. Clinical Journal of Oncology Nursing. Oncology Nursing Society (ONS). doi:10.1188/19.cjon.s1.27-34.
- Ventura, Filipa, Joakim Öhlén, and Ingalill Koinberg. 2013. “An Integrative Review of Supportive E-health Programs in Cancer Care”. European Journal of Oncology Nursing. Elsevier BV. doi:10.1016/j.ejon.2012.10.007.
- Madore, Shannon, Kristin Kilbourn, Patricia Valverde, Evelinn Borrayo, and Peter Raich. 2014. “Feasibility of a Psychosocial and Patient Navigation Intervention to Improve Access to Treatment Among Underserved Breast Cancer Patients”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-014-2176-5.
- Jansen, Femke, Cornelia F. van Uden-Kraan, Valesca van Zwieten, Birgit I. Witte, and Irma M. Verdonck-de Leeuw. 2014. “Cancer Survivors’ Perceived Need for Supportive Care and Their Attitude Towards Self-management and Ehealth”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-014-2514-7.
- Green, Amanda C., Laura L. Hayman, and Mary E. Cooley. 2015. “Multiple Health Behavior Change in Adults with or at Risk for Cancer: A Systematic Review”. American Journal of Health Behavior. JCFCorp SG PTE LTD. doi:10.5993/ajhb.39.3.11.
- Girault, Anne, Marie Ferrua, Benoît Lalloué, Claude Sicotte, Aude Fourcade, Fatima Yatim, Guillaume Hébert, Mario Di Palma, and Etienne Minvielle. 2015. “Internet-based Technologies to Improve Cancer Care Coordination: Current Use and Attitudes Among Cancer Patients”. European Journal of Cancer. Elsevier BV. doi:10.1016/j.ejca.2014.12.001.
- Rolfson, Ola, Kate Eresian Chenok, Eric Bohm, Anne Lübbeke, Geke Denissen, Jennifer Dunn, Stephen Lyman, et al.. 2016. “Patient-reported Outcome Measures in Arthroplasty Registries”. Acta Orthopaedica. Medical Journals Sweden AB. doi:10.1080/17453674.2016.1181815.
- Maziarz, Richard T., Edmund K. Waller, Ulrich Jaeger, Isabelle Fleury, Joseph McGuirk, Harald Holte, Samantha Jaglowski, et al.. 2020. “Patient-reported Long-term Quality of Life After Tisagenlecleucel in Relapsed/refractory Diffuse Large B-cell Lymphoma”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2019001026.
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- Hlubocky, Fay J., Kimberly Webster, Jennifer Beaumont, John Cashy, Diane Paul, Amy Abernethy, Karen L. Syrjala, Jamie Von Roenn, and David Cella. 2013. “A Preliminary Study of a Health Related Quality of Life Assessment of Priority Symptoms in Advanced Lymphoma: The National Comprehensive Cancer Network-functional Assessment of Cancer Therapy – Lymphoma Symptom Index”. Leukemia & Lymphoma. Informa UK Limited. doi:10.3109/10428194.2012.762977.
- Heitzmann, Carolyn A., Thomas V. Merluzzi, Pascal Jean-Pierre, Joseph A. Roscoe, Kenneth L. Kirsh, and Steven D. Passik. 2011. “Assessing Self-efficacy for Coping with Cancer: Development and Psychometric Analysis of the Brief Version of the Cancer Behavior Inventory (CBI-B)”. Psycho-oncology. Wiley. doi:10.1002/pon.1735.
- Harris, Paul A., Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, and Jose G. Conde. 2009. “Research Electronic Data Capture (redcap)—a Metadata-driven Methodology and Workflow Process for Providing Translational Research Informatics Support”. Journal of Biomedical Informatics. Elsevier BV. doi:10.1016/j.jbi.2008.08.010.
- Buitrago J, Adkins S, Hawkins M, Iyamu K, Oort T. Adult Survivorship: Considerations Following CAR T-Cell Therapy. Clin J Oncol Nurs. 2019 Apr 1;23(2):42-48. doi: 10.1188/19.CJON.S1.42-48.
- Chakraborty R, Sidana S, Shah GL, Scordo M, Hamilton BK, Majhail NS. Patient-Reported Outcomes with Chimeric Antigen Receptor T Cell Therapy: Challenges and Opportunities. Biol Blood Marrow Transplant. 2019 May;25(5):e155-e162. doi: 10.1016/j.bbmt.2018.11.025. Epub 2018 Nov 28.
- Ventura F, Ohlen J, Koinberg I. An integrative review of supportive e-health programs in cancer care. Eur J Oncol Nurs. 2013 Aug;17(4):498-507. doi: 10.1016/j.ejon.2012.10.007. Epub 2012 Nov 15.
- Girault A, Ferrua M, Lalloue B, Sicotte C, Fourcade A, Yatim F, Hebert G, Di Palma M, Minvielle E. Internet-based technologies to improve cancer care coordination: current use and attitudes among cancer patients. Eur J Cancer. 2015 Mar;51(4):551-557. doi: 10.1016/j.ejca.2014.12.001. Epub 2015 Feb 4.
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- 2022. "Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05199961.
Frequently Asked Questions
How many participants are currently enrolled in this research?
"Yes, the details found on clinicaltrials.gov suggest that this research is currently seeking volunteers. It was first launched January 25th 2022 and underwent its most recent update April 19th 2022, with a target of 100 patients at one site." - Anonymous Online Contributor
Unverified Answer
Are new recruits being accepted for this clinical trial?
"Affirmative. According to clinicaltrials.gov, the trial is actively recruiting for 100 participants at 1 centre and was first posted on January 25th 2022 with a last update occurring April 19th 2022." - Anonymous Online Contributor
Unverified Answer
Does this experiment allow for elderly individuals to participate?
"This medical study is searching for participants aged 18 or older, but no more than 90 years old." - Anonymous Online Contributor
Unverified Answer
Can I partake in this research endeavor?
"This research project is seeking 100 adults aged between 18 and 90 with b-cell lymphoma, diffuse. Criteria for admission into the study include being of legal age or older, access to a device that can receive calls, text messages, emails and internet connection in order to complete electronic assessments." - Anonymous Online Contributor
Unverified Answer