RecruitingNot ApplicableNCT07390071

Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy


Sponsor

University of Utah

Enrollment

40 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 21 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

Interventions

DEVICEHome Automated Telemanagement (HAT) Patient Unit

HAT (Home Automated Telemanagement) patient unit will guide patients in following their treatment plans, including exercise and diet prescriptions, monitor patients' progress and symptoms, and communication with health care providers. Participants will receive an internet-enabled device, either a touchscreen tablet or a virtual reality (VR) headset, as part of the patient unit, based on their personal preference. Participants will also be provided a pulse oximeter to monitor their heart rate and oxygen saturation, and a fitbit to assess daily physical activity and step counts.


Locations(1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States

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NCT07390071


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