Multimodal Telerehabilitation in Patients Undergoing CAR-T Cell Immunotherapy

January 28, 2026 updated by: University of Utah
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CAR-T therapy is a relatively new, innovative treatment strategy to manage refractory hematological cancers, including some types of leukemia, lymphoma, and multiple myeloma (Efficace, 2022). This pivotal treatment has become a standard-of-care for certain malignancies, such as relapsed non-Hodgkins lymphoma, relapsed or refractory acute lymphoblastic leukemia, and relapsed refractory multiple myeloma, with some studies showing at least 80% of the patients with a positive response to treatment (June, 2018; Landry, 2020). While CAR T-cell therapy has led to significant advances in the treatment of hematologic malignancies, it also presents a set of unique toxicities. The two most common acute adverse effects are cytokine release syndrome (CRS) and neurological toxicity known as immune effector cell-associated neurotoxicity syndrome (ICANS), respectively (Neelapu, 2017).

Recent studies suggest that there should be an emphasis on prehabilitation soon after initiating the workup process for CAR-T therapy, maintaining function during active treatment, and close follow-up with rehabilitation especially if neurological sequelae persist (Obaisi, 2022; Kiefer, 2023). Effective interventions are urgently needed to improve the QoL and functional capacity in patients with hematological cancers undergoing CAR-T therapy (Cenik, 2020;Jeevanantham, 2021). Physical activity programs have been shown to impact psychological symptoms, fatigue, and quality of life (Vermaete, 2013, 2014). Crucially, no evidence has been presented to date for patients with hematologic malignancies while undergoing CAR-T therapy. Thus, studies exploring approaches to expand access to multimodal cancer rehabilitation practices in these patients are necessary to address the needs of the rapidly growing population of cancer survivors receiving CAR-T therapy. Recent systematic reviews demonstrated the high potential of telehealth approaches to facilitate cancer rehabilitation (Brick, 2022; Chang, 2022).

Home Automated Telemanagement (HAT). The HAT system is a telemedicine platform supporting patients in following individualized self-care plans and assisting healthcare practitioners in the treatment and monitoring of their patients according to evidence-based guidelines (Finkelstein, 2012; Fleg, 2020; Shero, 2022). HAT is based on the chronic disease care model (Grover, 2014) and provides support for patient self-management, comprehensive patient-provider communication, and multidisciplinary care coordination (Drouin, 2015). The main objective of the HAT system is to minimize the burden of chronic disease management and to simplify monitoring in ambulatory care. To achieve this goal, the HAT system is required (1) to support a constant information feedback loop between the patient and health care providers; (2) to take over all routine repetitive tasks; and (3) to provide real-time clinical decision support both for the patient and clinician. HAT has been successfully implemented and tested in a variety of chronic diseases.

Patient units are used at patient homes to guide patients in following their treatment plans including exercise and diet prescriptions, monitor patients' progress and symptoms, and to communicate with health care providers. Any web-enabled device can serve as a patient unit including touchscreen tablets, VR headsets, and smartphones. The home unit interface underwent rigorous usability testing (Jeong, 2015; Finkelstein, 2021; Gabriel, 2023) and is very simple to operate, even by those without any prior computer experience. The clinician units (any web-enabled device) are used to set up and update individualized treatment plans, analyze patient self-testing results, and review computer-generated alerts. The HAT server implements computerized decision support based on individualized alert setup and realtime monitoring of patient self-testing data. In this study, the HAT system will be focused on the delivery of a multimodal cancer rehabilitation program comprising individualized therapeutic physical exercise, nutrition plan, behavioral counseling, and tailored educational empowerment targeting the social, cognitive, reproductive, and vocational needs of blood cancer survivors.

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.

This study will determine if patients with hematologic malignancies undergoing CAR-T therapy will demonstrate sufficient acceptability and adherence to the multimodal cancer telerehabilitation, and it will be associated with a positive trajectory of QoL, fitness, and patient-reported outcomes. This trial is an exploratory sequential mixed methods design to assess the feasibility of a patient-centered, culturally tailored telemedicine approach for multimodal cancer rehabilitation in patients with hematologic malignancies undergoing CAR-T therapy.

Eligible patients will undergo a four-week multimodal prehabilitation before the commencement of the CAR-T therapy and then receive continuous online empowerment and education support during CAR-T therapy while undergoing chemotherapy, CAR-T infusion, toxicity monitoring, and recovery for up to four weeks, depending on a specific CAR-T treatment regimen. This will be followed by a twelve-week multimodal telerehabilitation after treatment completion and hospital discharge. A comprehensive assessment will be conducted at the beginning of the study, and the patients will be individually prescribed resistance, aerobic, and relaxation exercises, and a nutrition plan for 4-week prehabilitation based on patient fitness levels and nutrition status. A mobile app will provide interactive education on cancer survivorship, early mobilization, and post-discharge self-care during CAR-T treatment comprising outpatient chemotherapy, CART infusion, and in-patient hospitalization for toxicity monitoring. After the hospital discharge, a 12-week multimodal rehabilitation plan will be provided via the telerehabilitation system which uses validated AI-driven real-time assessment of exercise exertion (Smiley, 2024). Social support will be delivered via group telecounseling sessions. Automated analysis of daily exercise and nutrition logs will alert the telerehabilitation team about low patient adherence and prompt tailored feedback by the telerehabilitation team. The acceptability, usability, feasibility, and adherence will be assessed at the end of the study as described in the Analysis Plan. Finally, this study will assess QoL, fitness, body composition, cancer symptoms, behavioral characteristics, and satisfaction with care before and after the multimodal rehabilitation delivered via a telemedicine platform.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute at University of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Score - Feasibility
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

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.
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.

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.
up to 12 weeks after completion of the CAR-T procedures.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk distance (6MWD)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

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.
up to 12 weeks after completion of the CAR-T procedures.
Short Physical Performance Battery (SPPB)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

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.
up to 12 weeks after completion of the CAR-T procedures.
Godin Leisure Score Index
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

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.
up to 12 weeks after completion of the CAR-T procedures.
Extended Activities of Daily Living (ADL)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

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.
up to 12 weeks after completion of the CAR-T procedures.
36-Item Short Form Survey (SF-36)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

SF-36 is a questionnaire that assesses patient health. This outcome measure will report 8 sub-scores: physical function, pain, limitations due to physical health issues, limitations due to personal/emotional issues, emotional well-being, social functioning, energy/fatigue, and general health perceptions.

Each sub-score ranges from 0-100, with higher score indicating more favorable health and lower score indicating less favorable health.
up to 12 weeks after completion of the CAR-T procedures.
European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

EORTC QLQ-C30 is a questionnaire to assess health-related quality of life in cancer patients. Patients indicate which symptoms/problems they have experienced during the past week, from "1 Not at All" to "4 Very Much".

The assessment will report data as 15 subscales with scores from 0-100. A high score indicates a higher response level.

A high functional scale score (FS) represents a high/healthy level of function and includes Physical, Role, Emotional, Cognitive, and Social functioning. A high symptom scale score (SS) represent a high level of symptomatology/problems and includes Fatigue, Nausea and vomiting, Pain, Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties, and Global health status/QoL.

This outcome will report the mean score of each subscale.
up to 12 weeks after completion of the CAR-T procedures.
Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

The FACT-F is a self-reported evaluation of fatigue in cancer patients. This questionnaire has patients rank statements regarding Physical, Social/Family, Emotional, and Functional well-being and Fatigue from 0 "Not at All" to 4 "Very Much".

The FACT-F has a minimum of 0 and a maximum of 52, with higher scores indicating less fatigue and lower scores indicating more fatigue.
up to 12 weeks after completion of the CAR-T procedures.
Numeric Rating Scale (NRS)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

NRS is a single-item question assessing pain. NRS scores range from 0-10, with lower scores indicating less pain and higher scores indicating more pain.

This outcome measure will report mean NRS.
up to 12 weeks after completion of the CAR-T procedures.
Exercise Self-Efficacy Scale (EXSE)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

The EXSE assesses exercise self-efficacy, or a patient's belief in their ability to continue regular exercise.

Outcome Expectations for Exercise Scale is an 8-item questionnaire. Each item is a 10-point scale, ranging from 0% (NOT AT ALL CONFIDENT) to 100% (Highly CONFIDENT).

Total score ranges from 0 to 100, with lower scores indicating worse exercise self-efficacy and higher scores indicating better exercise self-efficacy.
up to 12 weeks after completion of the CAR-T procedures.
Behavioral Regulation in Exercise Questionnaire 3 (BREQ-3)
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

BREQ-3 is an assessment measuring a patient's exercise motivation. BREQ-3 reports 6 sub-scores: Amotivation and External, Introjected, Identified, Integrated, and Intrinsic regulation.

BREQ-3 score ranges from 0 to 96. Lower scores indicate lower motivation, and higher scores indicate higher motivation.

This outcome measure will report the mean BREQ-3.
up to 12 weeks after completion of the CAR-T procedures.
Outcome Expectations for Exercise Scale
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

The Outcome Expectations for Exercise Scale assesses beliefs and attitudes about the benefits of exercise.

Outcome Expectations for Exercise Scale is a 15-item questionnaire. Each item is a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).

Total score ranges from 15 to 75, with lower scores indicating worse exercise attitudes and higher scores indicating better exercise attitudes.
up to 12 weeks after completion of the CAR-T procedures.
Medical Outcome Study (MOS) Exercise Adherence Questionnaire
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

The MOS Exercise Adherence Questionnaire assesses patient adherence to exercise.

MOS Exercise Adherence Questionnaire is a 40-item questionnaire. Scores range from 0 to 100, with lower scores indicating worse exercise adherence and higher scores indicating better exercise adherence.
up to 12 weeks after completion of the CAR-T procedures.
Telerehab user attitudes
Time Frame: up to 12 weeks after completion of the CAR-T procedures.

Telerehab user attitudes measure patients' overall feelings about remote rehabilitation technology and service. The minimum possible score is 11 (worst perceived attitude) and the maximum is 55 (best perceived attitude).

This outcome measure will report the mean Telerehab user attitudes at 12 weeks after completion of the CAR-T procedure.
up to 12 weeks after completion of the CAR-T procedures.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Douglas Sborov, MD, MS, Huntsman Cancer Institute/ University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCI190212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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