Recruiting

Telerehabilitation Model

Sponsor:

University of Utah

Code:

NCT07390071

Conditions

Lymphoma

Myeloma

Cytokine Release Syndrome

Immune Effector Cell Associated Neurotoxicity Syndrome

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Home Automated Telemanagement (HAT) Patient Unit

Study Details

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.

Conditions

Lymphoma

Myeloma

Cytokine Release Syndrome

Immune Effector Cell Associated Neurotoxicity Syndrome

Study ID

NCT07390071

Start date

Sep 1, 2025

Status verified date

Jan, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Multimodal Cancer Telerehabilitation

Each enrolled patient will undergo a four-week multimodal prehabilitation before the commencement of the CAR-T therapy. During CAR-T therapy, the patients will use an interactive app supporting cancer self-care education and early mobilization while undergoing chemotherapy, infusion, in-hospital toxicity monitoring, and recovery (the duration depends on the specific CAR-T treatment regimen). After completion of the CAR-T procedures and hospital discharge, the patients will undergo a 12-week home-based multimodal telerehabilitation.

Individualized rehabilitation plans using a web-based care management portal. 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.

Interventions

Home 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.

Primary outcome measure

  • System Usability Score - Feasibility [ Time Frame: up to 12 weeks after completion of the CAR-T procedures. ]
  • Adherence Indicators - Feasibility [ Time Frame: up to 12 weeks after completion of the CAR-T procedures. ]

Central Contacts and Locations

Central contacts

Aileen Gabriel

801-585-3229aileen.gabriel@utah.edu

Locations

Huntsman Cancer Institute at University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Douglas Sborov, MD, MS

801-585-3229Douglas.Sborov@hci.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Feb 5, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Utah on 2026-02-05.