Clinical trial · Interventional
Evaluating the Feasibility of a Digital Health Coaching Program for Individuals Following CAR T Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Leukemia, Acute Lymphoblastic | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Health Coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm Cohort Receiving Digital Health Coaching
- description
- All study participants will be enrolled in a 6-month digital health coaching program.
- interventionNames
- Behavioral: Digital Health Coaching
Primary outcomes (2)
- measure
- Feasibility of the intervention
- timeFrame
- Through study completion, at month 6
- description
- Feasibility is defined as a retention rate in the digital health coaching program greater than or equal to 60% at month 6
- measure
- Acceptability
- timeFrame
- Through study completion, at month 6
- description
- Acceptability will be assessed with a 3-item evaluation to address engagement, usefulness and relevance
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 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. * Non-English speaking/reading individuals.
References
Publications (16)
- BACKGROUNDBeaupierre 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
- BACKGROUNDBuitrago 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
- BACKGROUNDChakraborty 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
- BACKGROUNDGajra 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
- BACKGROUNDNabhan 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.
- BACKGROUNDLondon 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.
- BACKGROUNDGirault 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