Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy

NCT05064787 | Completed

• 1 other identifier: 2021-0543
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma; Lymphoma, B-Cell; Leukemia; Multiple Myeloma; Mantle Cell Lymphoma; Follicular Lymphoma; Leukemia, Acute Lymphoblastic

Keywords

Receptors, chimeric antigen; Adult; hematologic neoplasms; digital health coaching

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Cancer Behavior Inventory (CBI-B)

  Enrollment, Months 1, 3, 6

• Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)

  Enrollment, Months 1, 3, 6

• National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health 10

  Enrollment, Month 6

• Subjective Assessment of CAR T Management

  Enrollment, Months 1, 3, 6

Other Outcomes (3)

• Socio-demographic, clinical, and treatment characteristics

  Through study completion, at month 6

• Health Care Utilization

  Through study completion, at month 6

• Digital Engagement

  Through study completion, at month 6

Study Arms (1)

Single Arm Cohort Receiving Digital Health Coaching

OTHER

All study participants will be enrolled in a 6-month digital health coaching program.

Behavioral: Digital Health Coaching

Interventions

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.

Single Arm Cohort Receiving Digital Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and older
• Able to read, speak and consent in English
• Confirmed treatment with any commercially available or investigational CAR T cell therapy.
• 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.
• Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2

You may not qualify if:

• 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.
• Non-English speaking/reading individuals.

Sponsors & Collaborators

• Pack Health: lead
• M.D. Anderson Cancer Center: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (16)

• 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.

  PMID: 33520344 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.

  PMID: 30880816 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.

  PMID: 30500439 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.

  PMID: 32552151 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.

  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.

  PMID: 25661828 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.

  PMID: 24639035 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.

  PMID: 25741683 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.

  PMID: 32533435 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.

  PMID: 20878830 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.

  PMID: 23320888 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.

  PMID: 19543809 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.

  PMID: 31187535 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.

  PMID: 32088365 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.

  PMID: 18929686 BACKGROUND

MeSH Terms

Conditions

Lymphoma; Lymphoma, B-Cell; Leukemia; Multiple Myeloma; Lymphoma, Mantle-Cell; Lymphoma, Follicular; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Hematologic Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Leukemia, Lymphoid; Neoplasms by Site

Study Officials

• Sherry Adkins, MSN

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: October 1, 2021
• Study Start: March 11, 2022
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)