NCT07390071

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
33mo left

Started Sep 2025

Typical duration for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
Sep 2025Jan 2029

Study Start

First participant enrolled

September 1, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

LymphomaMyelomaCytokine Release SyndromeImmune Effector Cell Associated Neurotoxicity Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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.

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

  • 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.

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

Secondary Outcomes (13)

  • 6-minute walk distance (6MWD)

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

  • Short Physical Performance Battery (SPPB)

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

  • Godin Leisure Score Index

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

  • Extended Activities of Daily Living (ADL)

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

  • 36-Item Short Form Survey (SF-36)

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

  • +8 more secondary outcomes

Study Arms (1)

Multimodal Cancer Telerehabilitation

EXPERIMENTAL

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

Interventions

Home Automated Telemanagement (HAT) Patient UnitDEVICE

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.

Multimodal Cancer Telerehabilitation

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

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MeSH Terms

Conditions

LymphomaNeoplasms, Plasma CellCytokine Release Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Douglas Sborov, MD, MS

    Huntsman Cancer Institute/ University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aileen Gabriel

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

February 5, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)