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.
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.
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.
Single group
Home Automated Telemanagement (HAT) Patient Unit
DeviceHAT (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.
System Usability Score - Feasibility
To assess the feasibility of a multimodal cancer telerehabilitation model in patients with hematologic malignancies undergoing CAR-T therapy by evaluating system usability, acceptability, and exercise adherence. This outcome measure will report the System Usability Score for home telerehabilitation in patients undergoing CAR-T therapy. The System Usability Scale (SUS) is a 10-item, 5-point Likert questionnaire that yields a single usability score on a 0-100 scale; the minimum possible score is 0 (worst perceived usability) and the maximum is 100 (best perceived usability). This outcome measure will report the mean System Usability Score at 12 weeks after completion of the CAR-T procedure.
Adherence Indicators - Feasibility
To assess the feasibility of a multimodal cancer telerehabilitation model in patients with hematologic malignancies undergoing CAR-T therapy by evaluating daily exercise logs. This outcome measure will report adherence based on daily exercise logs in patients utilizing the home telerehabilitation after undergoing CAR-T therapy. Adherence will be defined as the percentage of exercise sessions of the total number of prescribed exercise sessions.
6-minute walk distance (6MWD)
6MWD is an assessment of functional and aerobic capacity by measuring how far a patient can walk over 6 minutes. This outcome measure will report mean 6MWD.
Short Physical Performance Battery (SPPB)
The Short Physical Performance Battery (SPPB) is a series of assessments to measure balance, strength, and physical functioning. SPPB scores range from 0-12, with lower scores indicating severe limitations and higher scores indicating better physical functioning. This outcome measure will report mean SPPB.
Godin Leisure Score Index
Godin Leisure Score Index is a questionnaire to assess time spent in leisure exercise. Godin Leisure Score Index is a continuous index, with a minimum of 0. Lower scores indicate lower activity and higher cores indicate higher activity. This outcome measure will report mean Godin Leisure Score Index.
Extended Activities of Daily Living (ADL)
The Extended ADL scale is an assessment of functional independence. Extended ADL is a 22-item questionnaire, with each item scaled from 0 to 3. The Extended ADL total score ranges from 0 to 66, with lower scores indicating better functional independence and higher scores indicating worse functional independence.
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University of Utah
Lead sponsor
United States Department of Defense
Collaborator
