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Recruiting NCT07390071

Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy

Trial Parameters

Condition Lymphoma
Sponsor University of Utah
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2025-09-01
Completion 2029-01
Interventions
Home Automated Telemanagement (HAT) Patient Unit

Brief Summary

The proposed multimodal telerehabilitation model allows a rehabilitation therapy team to set up individualized rehabilitation plans using a web-based care management portal and monitor patient progress online. Patients at home follow a safe and effective personalized exercise and nutrition plan guided by interactive touch-screen technology combined with behavioral counseling, social support, and interactive education and empowerment. The design of the telerehabilitation system is based on the cloud-based Internet-of-Things architecture allowing real-time monitoring of cardiovascular parameters and exercise performance. The patient's level of exertion during exercise is automatically identified by a validated AI-driven algorithm supporting exercise safety and efficacy. The ultimate goal of this pilot feasibility project is to establish the extent of the impact of the proposed patient-centered cancer telerehabilitation model on disease-specific quality of life, and functional and symptom outcomes and to obtain sufficient evidence for a definitive randomized clinical trial evaluating this approach in a multi-center study.

Eligibility Criteria

Inclusion Criteria: * age \>21 * confirmed diagnosis of lymphoma or myeloma * commercial FDA-approved CAR-T delivery planned for ≥4 weeks following enrollment * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Access to a working telephone line in their home or a cell phone. Exclusion Criteria: * have unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers, painful or unstable bony metastases, or recent skeletal fractures; * are engaged in a regular exercise rehabilitation program; * have relocation plans within next 6 months; * participate in another clinical trial.

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