Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
NCT ID: NCT05199961
Last Updated: 2023-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
4 participants
INTERVENTIONAL
2022-01-25
2022-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 for whom there is documentation of inability to provide consent in the medical record
18 Years
90 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Ohio State University Comprehensive Cancer Center
OTHER
Pack Health
INDUSTRY
Responsible Party
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Principal Investigators
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Gretchen McNally, PhD
Role: PRINCIPAL_INVESTIGATOR
The Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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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.
Beaupierre A, Lundberg R, Marrero L, Jain M, Wang T, Alencar MC. Management Across Settings: An Ambulatory and Community Perspective for Patients Undergoing CAR T-Cell Therapy in Multiple Care Settings. Clin J Oncol Nurs. 2019 Apr 1;23(2):27-34. doi: 10.1188/19.CJON.S1.27-34.
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.
Madore S, Kilbourn K, Valverde P, Borrayo E, Raich P. Feasibility of a psychosocial and patient navigation intervention to improve access to treatment among underserved breast cancer patients. Support Care Cancer. 2014 Aug;22(8):2085-93. doi: 10.1007/s00520-014-2176-5. Epub 2014 Mar 18.
Jansen F, van Uden-Kraan CF, van Zwieten V, Witte BI, Verdonck-de Leeuw IM. Cancer survivors' perceived need for supportive care and their attitude towards self-management and eHealth. Support Care Cancer. 2015 Jun;23(6):1679-88. doi: 10.1007/s00520-014-2514-7. Epub 2014 Nov 26.
Green AC, Hayman LL, Cooley ME. Multiple health behavior change in adults with or at risk for cancer: a systematic review. Am J Health Behav. 2015 May;39(3):380-94. doi: 10.5993/AJHB.39.3.11.
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.
Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
Maziarz RT, Waller EK, Jaeger U, Fleury I, McGuirk J, Holte H, Jaglowski S, Schuster SJ, Bishop MR, Westin JR, Mielke S, Teshima T, Bachanova V, Foley SR, Borchmann P, Salles GA, Zhang J, Tiwari R, Pacaud LB, Ma Q, Tam CS. Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2020 Feb 25;4(4):629-637. doi: 10.1182/bloodadvances.2019001026.
Bunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1.
Hlubocky FJ, Webster K, Beaumont J, Cashy J, Paul D, Abernethy A, Syrjala KL, Von Roenn J, Cella D. 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. Leuk Lymphoma. 2013 Sep;54(9):1942-6. doi: 10.3109/10428194.2012.762977. Epub 2013 Feb 7.
Heitzmann CA, Merluzzi TV, Jean-Pierre P, Roscoe JA, Kirsh KL, Passik SD. Assessing self-efficacy for coping with cancer: development and psychometric analysis of the brief version of the Cancer Behavior Inventory (CBI-B). Psychooncology. 2011 Mar;20(3):302-12. doi: 10.1002/pon.1735.
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
Related Links
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FDA approves tisagenlecleucel for adults with relapsed or refractory large B-cell lymphoma
Other Identifiers
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2021C0141
Identifier Type: -
Identifier Source: org_study_id
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