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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
| Bristol-Myers Squibb | INDUSTRY |
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The aim of this study is to evaluate the feasibility of a digital health coaching program for, and to describe quality of life of, individuals in the 6 months following chimeric antigen receptor (CAR) T cell therapy. Up to 50 English-speaking individuals aged 18 and older who are to receive treatment with a CAR T cell therapy will be enrolled, all at The University of Texas MD Anderson Cancer Center. Participants must have internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments and will be excluded if they are unable to provide informed consent or have a prognosis of 6 months or less.
Consented participants will be enrolled in a 6-month digital health coaching program delivered via weekly calls from a Health Advisor coupled with the digital delivery of content. The program focuses on identification and escalation of treatment-related toxicity, communication with providers, and physical and psychosocial health following treatment. Health related quality of life (HRQoL) will be assessed with the Functional Assessment of Cancer Therapy-Lymphoma (FACT-L), health self-efficacy will be assessed by the Cancer Behavior Inventory-Brief (CBI-B), physical and mental health outcomes will be measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10. Patient experience in managing CAR T specific care will be assessed with a 5-item questionnaire developed specifically for use in this study, focused on participants' confidence in understanding, identifying and managing symptoms, and communicating with providers. Study outcomes will contribute to knowledge about if and how a digital health intervention may be used to support individuals post-CAR T cell therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Cohort Receiving Digital Health Coaching | Other | All study participants will be enrolled in a 6-month digital health coaching program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health Coaching | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the intervention | Feasibility is defined as a retention rate in the digital health coaching program greater than or equal to 60% at month 6 | Through study completion, at month 6 |
| Acceptability | Acceptability will be assessed with a 3-item evaluation to address engagement, usefulness and relevance | Through study completion, at month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Behavior Inventory (CBI-B) | 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Socio-demographic, clinical, and treatment characteristics | Age, Race, Ethnicity, Sex at Birth, Gender Identity, Diagnosis, Treatment History, Co-morbid conditions | Through study completion, at month 6 |
| Health Care Utilization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherry Adkins, MSN | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33520344 | Background | Beaupierre A, Kahle N, Lundberg R, Patterson A. Educating Multidisciplinary Care Teams, Patients, and Caregivers on CAR T-Cell Therapy. J Adv Pract Oncol. 2019 May-Jun;10(Suppl 3):29-40. doi: 10.6004/jadpro.2019.10.4.12. Epub 2019 May 1. | |
| 30880816 | Background | 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. |
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A single cohort of 50 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 from a single site, The University of Texas MD Anderson Cancer Center.
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|
| Enrollment, Months 1, 3, 6 |
| Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) | 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. | Enrollment, Months 1, 3, 6 |
| National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10 | Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale is a ten item likert-scale survey that evaluates physical, social, and psychological well-being. The instrument consists of two scales, one for global physical health and one for global mental health. | Enrollment, Month 6 |
| Subjective Assessment of CAR T Management | 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. | Enrollment, Months 1, 3, 6 |
ER visits and unplanned hospitalizations
| Through study completion, at month 6 |
| Digital Engagement | Frequency, types and duration of engagement with the digital health coaching platform | Through study completion, at month 6 |
| 30500439 | Background | 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. |
| 32552151 | Background | Gajra A, Jeune-Smith Y, Kish J, Yeh TC, Hime S, Feinberg B. Perceptions of community hematologists/oncologists on barriers to chimeric antigen receptor T-cell therapy for the treatment of diffuse large B-cell lymphoma. Immunotherapy. 2020 Jul;12(10):725-732. doi: 10.2217/imt-2020-0118. Epub 2020 Jun 18. |
| Background | Nabhan C, Jeune-Smith Y, Klinefelter P, Fillman J, Feinberg BA. Community Oncologists 'Perception and Adaptability to Emerging Chimeric Antigen T-Cell Therapy. J Clin Pathways. 2017;3(8):31-35. |
| Background | London S. Logistics of CAR T-cell therapy in real-world practice. The ASCO Post website ascopost.com/issues/may-25-2018/logistics-of-car-t-cell-therapy-in-real-world-practice Published May. 2018;25. |
| 25661828 | Background | 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. |
| 24639035 | Background | 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. |
| 25741683 | Background | 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. |
| 32533435 | Background | Aapro M, Bossi P, Dasari A, Fallowfield L, Gascon P, Geller M, Jordan K, Kim J, Martin K, Porzig S. Digital health for optimal supportive care in oncology: benefits, limits, and future perspectives. Support Care Cancer. 2020 Oct;28(10):4589-4612. doi: 10.1007/s00520-020-05539-1. Epub 2020 Jun 12. |
| 20878830 | Background | 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. |
| 23320888 | Background | 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. |
| 19543809 | Background | Hays RD, Bjorner JB, Revicki DA, Spritzer KL, Cella D. Development of physical and mental health summary scores from the patient-reported outcomes measurement information system (PROMIS) global items. Qual Life Res. 2009 Sep;18(7):873-80. doi: 10.1007/s11136-009-9496-9. Epub 2009 Jun 19. |
| 31187535 | Background | Neelapu SS. Managing the toxicities of CAR T-cell therapy. Hematol Oncol. 2019 Jun;37 Suppl 1:48-52. doi: 10.1002/hon.2595. |
| 32088365 | Background | Amonoo HL, Kurukulasuriya C, Chilson K, Onstad L, Huffman JC, Lee SJ. Improving Quality of Life in Hematopoietic Stem Cell Transplantation Survivors Through a Positive Psychology Intervention. Biol Blood Marrow Transplant. 2020 Jun;26(6):1144-1153. doi: 10.1016/j.bbmt.2020.02.013. Epub 2020 Feb 20. |
| 18929686 | Background | 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. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D007938 | Leukemia |
| D009101 | Multiple Myeloma |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D006402 | Hematologic Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D007945 | Leukemia, Lymphoid |
| D009371 | Neoplasms by Site |
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