CELL INTELLIGENCE · 肿瘤细胞治疗研究

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.

主要终点：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.
次要终点：6-minute walk distance (6MWD)；Short Physical Performance Battery (SPPB)；Godin Leisure Score Index；Extended Activities of Daily Living (ADL)；36-Item Short Form Survey (SF-36)；European Organization For Research And Treatment Of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)；Functional Assessment of Cancer Therapy-Fatigue (FACT-F)；Numeric Rating Scale (NRS)

• 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.

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.